Qualified Level Training

Theory of Counterpulsation

Cardiac Structure and Position

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Cardiac Structure and Position

2nd – 3rd ICS

5th – 6th ICS

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Cardiac Structure and Position

Right Atrium Left Atrium

Tricuspid Valve Mitral Valve

Right Ventricle Left Ventricle

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Cardiac Structure and Position

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Cardiac Structure and Position

Pulmonary Artery

Pulmonic Valve

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Cardiac Structure and Position

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Phases of the Cardiac Cycle

Systole: Diastole:

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Phases of the Cardiac Cycle

• Atrial Systole
• Isovolumetric Contraction
• Ventricular Ejection
• Isovolumetric Relaxation
• Ventricular Filling
• Atrial Systole

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Phases of the Cardiac Cycle

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Phases of the Cardiac Cycle

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Phases of the Cardiac Cycle

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Phases of the Cardiac Cycle

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Phases of the Cardiac Cycle

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Phases of the Cardiac Cycle

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Phases of the Cardiac Cycle

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Phases of the Cardiac Cycle

MAP – Mean Arterial Pressure = Systolic + (Diastolic x 2)

3
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Determinants of Myocardial Oxygen Supply and Demand

Myocardial Oxygen Supply Myocardial Oxygen Demand

• Coronary Artery Anatomy • Heart Rate
• Diastolic Pressure • Afterload
• Diastolic Time • Preload
• Oxygen Extraction • Contractility
• Hemoglobin
• PaO2

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Myocardial Oxygen Supply

Coronary Artery Anatomy

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Myocardial Oxygen Supply

Coronary Artery Anatomy

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Myocardial Oxygen Supply

Diastolic Pressure

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Myocardial Oxygen Supply

Diastolic Time

Diastolic Phase Diastolic Phase

60 bpm 130 bpm
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Myocardial Oxygen Supply

Oxygen Extraction – Hemoglobin and PaO2

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Determinants of Myocardial Oxygen Supply and Demand

Myocardial Oxygen Supply Myocardial Oxygen Demand

• Coronary Artery Anatomy • Heart Rate
• Diastolic Pressure • Afterload
• Diastolic Time • Preload
• Oxygen Extraction • Contractility
• Hemoglobin
• PaO2

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Myocardial Oxygen Demand

Heart Rate

Play Video

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Myocardial Oxygen Demand

Afterload

Aorta

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Myocardial Oxygen Demand

Preload

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Myocardial Oxygen Demand

Contractility

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14
Measurement of Cardiac Performance

Cardiac Output

Heart Rate Stroke Volume

Preload Contractility Afterload

Diastolic Arterial
Filling Fiber Contractile Pressure
Stretch Force

Ventricular Size
Reprinted with permission from Pierce and Wilson, Pathophysiology: Clinical Concepts of Disease Processes, 1978, McGraw-Hill

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Measurement of Cardiac Performance

.
Measurement Normal
4-6 liters/minute
Cardiac Output = Heart Rate x Stroke Volume

Cardiac Index = Cardiac Output

Normal = 2.5-3.5 l/min/m²
Body Surface Area
Systemic Vascular Resistance =
(Mean Arterial Pressure-Mean RA) x 80 900-1500 dynes/sec./cm-5)
Cardiac Output

Ejection Fraction =
end diastolic volume – end systolic volume (60-75% of end diastolic
end diastolic volume volume)

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Frank – Starling Law

160
Cardiac
Reserve Cardiac
Failure
Stroke 120
Volume
ml As the end-diastolic
volume increases, so
80 does the force of
ventricular contraction.
The stroke volume
40 increases up to a
critical point after
which stroke volume
decreases and cardiac
failure results.
100 200 300 400
End-Diastolic Volume
Price and Wilson, Pathophysiology Clinical Concepts of Disease Processes 1978, McGraw-Hill Book Company.

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Left Ventricular Failure

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Left Ventricular Failure

Three Stages

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Left Ventricular Failure

Vasoconstriction

 Pumping efficiency
 LV Volume & Pressure
Baroreceptors Activate
 HR
 Release of Catecholamines
 Afterload (SVR)
 O2 Demand
 Preload (LVEDP)

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Left Ventricular Failure

Hypervolemia
 Cardiac Output
 Glomerular Filtration Pressure
Activation of Renin-Angiotensin
Aldosterone - ADH
 Na+ & H2O Reabsorption
  Preload (LVEDP)
  Afterload (SVR)
  O2 Demand
  C.O.
  HR
  O2 Supply
  Pulmonary Artery Pressure

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Left Ventricular Failure

Tissue Hypoxia
Pulmonary Edema

 Oxygenation

 Contractility

   C.O.

 BP

Anaerobic Metabolism

Lactic Acid Production

Tissue Acidosis

Tissue Anoxia

DEATH

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Left Ventricular Failure

When to intervene with counterpulsation

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Left Ventricular Failure

When to intervene with counterpusation

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Primary Effects of IABC

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The Mechanics of Intra-Aortic

Balloon Counterpulsation

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Left Ventricular Failure

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Intra-aortic Balloon Insertion

Play Video

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IAB Catheter Sizing Guidelines

Note: This information is to be used as a guidance only. Clinical information and patient factors such as torso length should be
considered when selecting the appropriate balloon size. SENSATION and SENSATION PLUS are fiber-optic IAB catheters.

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IAB Catheter Placement

Incorrect Correct

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IAB Catheter Placement

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IAB Catheter Placement

Too High

Ideal

Too Low

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IAB Inflation

Diastole

• Augmentation of diastolic
pressure

• Increase coronary perfusion

• Increase Myocardial Oxygen

Supply

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IAB Deflation

Systole

• Decrease afterload

• Decrease cardiac work

• Decrease myocardial
oxygen consumption

• Increase cardiac output

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Secondary Effects of IAB Counterpulsation

• Cardiac Output 
• Heart Rate 
• Pulmonary Artery Diastolic Pressure
and Pulmonary Capillary Wedge
Pressure 
• Systemic Vascular Resistance 
• Blood Pressure
• Systolic 
• Diastolic 
• Mean Arterial Pressure 
• Diastolic Augmentation 

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Systemic Effects of Counterpulsation

• Neurologic

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Systemic Effects of Counterpulsation

• Neurologic
• Respiratory

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Systemic Effects of Counterpulsation

• Neurologic
• Respiratory
• Renal

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Systemic Effects of Counterpulsation

• Neurologic
• Respiratory
• Renal
• Vascular

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Trigger and Timing

Synchronization with the Cardiac Cycle
ECG Trigger Event – R wave
IAB Inflation - Diastole

Trigger Event Electrocardiogram

TRIGGER

Dicrotic Notch

Arterial Pressure

TIMING
IAB Inflated

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IAB Timing

D Increased Coronary
Artery Perfusion A = One cardiac cycle
C B = Unassisted End Diastole
F
C = Unassisted Systole
Dicrotic D = Augmented Diastole
Notch E = Assisted End Diastole
F = Assisted Systole

B Reduced
A E Myocardial O2
Demand

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Optimal Timing Assessment

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IABP Frequency – 1:1

Diastolic
Augmentation
Assisted Systole

One Cardiac Assisted End

Cycle Diastolic Pressure

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IABP Frequency – 1:2

Diastolic
Augmentation
Unassisted Assisted
Systole Systole

Unassisted End
One Cardiac Assisted End
Diastolic Pressure
Cycle Diastolic Pressure

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IABP Frequency – 1:3

Diastolic
Augmentation
Assisted
Unassisted Systole
Systole

One Cardiac Cycle Unassisted End Assisted End

Diastolic Pressure Diastolic Pressure

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Timing Errors

Early Inflation

Inflation of the IAB prior to aortic valve closure

Waveform Characteristics:
• Inflation of IAB prior to dicrotic
notch
• Diastolic augmentation
encroaches onto systole (may be
unable to distinguish)

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Timing Errors

Early Inflation

Inflation of the IAB prior to aortic valve closure

Physiologic Effects:
• Potential premature closure of
aortic valve
• Potential increase in
LVEDV/LVEDP/PCWP
• Increased left ventricular wall
stress or afterload
• Aortic regurgitation
• Increased MVO2 demand

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Timing Errors

Late Inflation

Inflation of the IAB markedly after closure of the aortic valve:

Waveform Characteristics:
• Inflation of IAB after the dicrotic
notch
• Absence of sharp V
• Sub-optimal diastolic
augmentation

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Timing Errors

Late Inflation

Inflation of the IAB markedly after closure of the aortic valve:

Physiologic Effects:
• Sub-optimal coronary artery
perfusion

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Timing Errors

Early Deflation

Premature deflation of the IAB during the diastolic phase

Waveform Characteristics:
• Deflation of IAB is seen as a sharp
drop following diastolic
augmentation
• Sub-optimal diastolic augmentation
• Assisted aortic end-diastolic
pressure may be equal to or less
than unassisted aortic end-diastolic
pressure
• Assisted systolic pressure may rise

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Timing Errors

Early Deflation

Premature deflation of the IAB during the diastolic phase

Physiologic Effects:
• Sub-optimal coronary perfusion
• Potential for retrograde coronary &
carotid blood flow
• Angina may occur as a result of
retrograde coronary blood flow
• Sub-optimal afterload reduction
• Increased MVO2 demand

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Timing Errors

Late Deflation

Deflation of the IAB as the aortic valve is beginning to open

Waveform Characteristics:
• Assisted aortic end-diastolic
pressure may be equal to the
unassisted aortic end-diastolic
pressure
• Rate of rise of assisted systole is
prolonged
• Diastolic augmentation may
appear widened

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Timing Errors

Late Deflation

Deflation of the IAB as the aortic valve is beginning to open

Physiologic Effects:
• Afterload reduction is
essentially absent
• Increased MVO2 consumption
due to the left ventricle ejecting
against a greater resistance &
a prolonged isovolumetric
contraction phase
• IAB may impede left ventricular
ejection and increase afterload

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Factors Affecting Augmentation

Sub-optimal Augmentation

Sub-optimal Diastolic Augmentation

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Factors Affecting Diastolic Augmentation

Patient Hemodynamics

• Heart Rate
• Stroke Volume
• Mean Arterial Pressure
• Systemic Vascular Resistance

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Factors Affecting Augmentation

Intra-aortic Balloon Catheter

• IAB in sheath
• IAB not unfolded
• IAB position
• Kink in IAB catheter
• IAB leak
• Low Helium concentration

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Factors Affecting Diastolic Augmentation

Intra-Aortic Balloon Pump

• Timing
• Position of the IAB
Augmentation control

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Questions?

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36
 Thank You

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Qualified Level Training

IAB Catheters

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Counterpulsation Market History

2016

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IAB Catheter History

1985 2011
1979 First pre-folded SENSATION®
World’s first balloon
2007 PLUS 8Fr. 50cc
percutaneous 2001 SENSATION® Fiber-optic IAB
PERCOR STAT-
IAB catheter FIDELITY® 8Fr. 7Fr. Fiber-optic catheter
DL® 10.5Fr. IAB
IAB catheter IAB catheter

1998 2004
2009
TRUE LINEAR® 2012
1981 MEGA® 8Fr.
SHEATHLESS® 7.5Fr. IAB SENSATION®
First dual 50cc IAB
9.5 Fr. IAB catheter PLUS 7.5Fr.
lumen IAB catheter
40cc Fiber-optic
IAB catheter
MEGA® 7.5 Fr.
30 & 40cc IAB
catheter

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IAB Position

Tip of the IAB catheter:

Approximately 1-2 cm distal to the
left subclavian artery

Base of the balloon membrane:

• Positioned above the renal
arteries:
• avoid compromise to renal
perfusion
• avoid abrasive trauma to
balloon membrane from plaque

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IAB Position

2nd – 3rd ICS

5th – 6th ICS

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IAB Position

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IAB Catheters

Conventional IAB Catheter

Fiber Optic IAB Catheter

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IAB Catheter Features
Conventional IAB Catheter Components

STAT-GARD Sleeve
Universal Sheath Seal
Y- fitting

Inner Lumen

Catheter Shaft
Suture Pads

Extracorporeal
Tubing

Proximal Marker Balloon Membrane Distal Marker

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IAB Catheter Features

Catheter Construction

Co-lumen Design vs. Co-axial

• Gas Passage Area: shuttles helium
• Inner Lumen: insertion over guide wire and
arterial pressure monitoring Co-lumen Design

Gas Passage Inner Lumen

Area

Co-axial Design

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IAB Catheter Features
Catheter Construction

Co-lumen Design vs. Co-axial

• Inner Lumen Diameter and Guide Wire:

Co-lumen Design

Guide Wire Inner Lumen

Diameter
SENSATION 0.018” 0.020”
LINEAR, Mega 0.025” 0.027”
And SENSATION
PLUS

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Arterial Pressure Monitoring

Conventional (Fluid-Filled) Pressure System

Low-compliance
pressure tubing

Traditional IAB catheters transmit a pressure Three-way

stopcock
signal through the fluid-filled inner lumen to an
external pressure transducer, then to the pump
via a pressure transducer cable
Transducer

System requires periodic zeroing to atmosphere.

Transducer leveled to right atrium.
Fast-flush
device

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Fluid-Filled (Conventional) Signal Transmission

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Maquet’s Fiber-Optic Pressure Sensor

The fiber-optic pressure sensor is located in the tip of the Sensation and
Sensation Plus IAB catheter and transmit the pressure signal by light
through a fiber-optic strand to the CS300 and Cardiosave IABPs.
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Comparison of Fiber-optic Sensor to
Conventional Pressure Sensor

Conventional
pressure sensor
Fiber-optic
pressure sensor

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Proprietary
Balloon Membrane

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Proprietary IAB Membrane

Proprietary IAB Membrane Provides Better Performance

IAB Membrane Abrasion

Patented blow-molded polyurethane Resistance
5
material is stronger, more durable, yet
4.5
thinner than any previous membrane.
4
• Abrasion resistance improved by 43% 3.5
• Improved fatigue resistance 3
• Immediate inflation on start-up 2.5
2
• Reduced insertion force
1.5
1
0.5
0
Proprietary IAB Competitor
Membrane Cardiothane™ II

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Proprietary Membrane
Technical Tips for Proprietary Membrane

The membrane handles and appears

different:
• Use only the introducer dilator and sheath that
are packaged with the insertion kit
• Balloon prep - apply and maintain vacuum by
leaving one-way valve in place until after
catheter is inserted
• Keep the balloon in the T-handle until ready to
insert catheter over the guide wire

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Proprietary Membrane
Technical Tips for Proprietary Membrane

The membrane handles and appears

different:
• Do not dip, wipe, or handle the membrane prior
to insertion
• Do not twist the catheter during insertion
• Always advance in short, continuous one inch
(2.5cm) strokes (as close to the insertion site as
possible) to avoid kinking the IAB catheter

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LINEAR ® 7.5Fr. IAB Catheter

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LINEAR 7.5Fr. IAB Catheter
Key Features and Benefits

• Small 7.5Fr. IAB

• Smaller profile without compromising
performance
• Wire reinforced sheath
• Easy to insert
• Proprietary IAB membrane

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LINEAR 7.5Fr. IAB Catheter

Small Catheter Diameter

The smaller 7.5Fr. size is ideal for

small adults, diabetics, and patients
with PVD
• Reduced catheter cross section area by
12% vs. 8Fr
• Smaller catheter size allows increased
distal flow
• Minimize the size of the arterial puncture
• Ease of insertion into smaller or diseased
vessel lumens
• 43% reduction in insertion force compared
to competitor’s 7.5Fr. IAB catheter

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LINEAR 7.5Fr. IAB Catheter
Small Catheter Diameter

LINEAR 7.5Fr. displayed faster cycle time

Smaller profile without compromised
performance
• Faster gas shuttle performance allows
better support of rapid heart rates and
arrhythmias
• LINEAR has 19% faster cycle time in
80°bend test method compared to
competitive IAB catheters

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LINEAR 7.5Fr. IAB Catheter

Proprietary Membrane

Proprietary IAB Membrane provides

better performance
• Abrasion resistance improved 43%
• Improved fatigue resistance
• Immediate inflation at start-up
• Reduced insertion force

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48
LINEAR 7.5Fr. IAB Catheter
Fatigue and Abrasion Leaks

LINEAR IABs showed a 50% decrease in balloon membrane leaks

Fatigue and Abrasion Leaks
2005-2009

0.1

0.08

0.06

0.04

0.02

0
Linear IAB Catheter

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LINEAR 7.5 Fr. IAB Catheters

IAB Catheter Tray
STAT-GARD Sleeve
Extracorporeal Tubing
Stylet Y-fitting Universal Sheath Seal

T-Handle Retainer 30 cc syringe with

one-way valve Catheter
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49
LINEAR 7.5 Fr. IAB Catheter
IAB Insertion Kit
Pressure Tubing 4.5Fr. to 7.5Fr. 18 gauge
and Luer Cap Catheter Extender Vessel Dilator Angiographic Needle

3-way
Stopcock

0.025” Guidewire Pressure Tubing Introducer 7.5Fr. Introducer Sheath

Dilator with hemostasis valve
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LINEAR 7.5Fr. IAB Catheter

Technical Specifications

Catheter Size 7.5Fr.

Balloon Size 25cc, 34cc, 40cc
Balloon Membrane When Folded 7.5Fr.
Balloon Material Proprietary material / blow molded
Balloon Membrane Length 173mm (25cc), 219mm (34cc), 258mm (40cc)
Balloon Membrane Diameter 15mm
Catheter Insertable Length 72.3cm
Catheter Shaft Design Co-lumen / Co-extruded
Catheter Shaft Material Polyurethane / Polyimide
Arterial Pressure Lumen Diameter 0.027“
Guidewire 0.025“
Sheath Size 7.5Fr.
Catheter Extender 183cm / 6 feet (34cc,40cc) 152cm / 5 feet (25cc)

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50
IAB Catheter Sizing Guidelines

Note: This information is to be used as a guidance only. Clinical information and patient factors such as torso length should
be considered when selecting the appropriate balloon size. SENSATION and SENSATION PLUS are fiber-optic IAB catheters.
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LINEAR 7.5Fr. IAB Catheter

Marketing Literature

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51
SENSATION 7Fr.
Fiber-Optic IAB Catheter
QLT - Sales – IAB Catheters ML-0580-02 Rev B
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SENSATION 7Fr. Fiber-Optic IAB Catheter

Key Features and Benefits

• SENSATION 7Fr. is the smallest IAB

catheter available with fiber-optic
technology.
• In-vivo calibration for accurate arterial
blood pressure waveform
• Fiber-optic sensor instantaneously
transmits a precise pressure signal to
the IABP
• Provides a clean, crisp arterial
pressure waveform
• Maquet’s proprietary membrane

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SENSATION 7Fr. Fiber-Optic IAB Catheter
Smaller Catheter Size

• 15% increase in the amount of distal

flow vs. 8Fr.
• 23% reduction in catheter cross-
sectional area
• Potential for smaller arteriotomy
• Potential for reduced limb ischemia

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SENSATION 7FR. Fiber-Optic IAB Catheter

Fiber-Optic Technology

• A miniature pressure sensor is mounted inside the tip of the IAB

• Light travels from the pump through the fiber-optic cable to the pressure sensor
• The sensor responds to the arterial pressure and creates a light pattern that is
sent back to the CS300 and CARDIOSAVE IABPs
• The pump translates the light pattern into pressure readings for accuracy in
measuring pressure

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53
Sensation 7Fr. Fiber-Optic IAB Catheter
In vivo Calibration

In vivo calibration gives you the confidence that the fiber-optic

pressure waveform is consistently accurate

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Sensation 7Fr. Fiber-Optic IAB Catheter

Insertion Tray

Helium Extender Tubing

(w/blue clips)
18g Needle

3-Way Stopcock

0.035” Guide
wire

4 Fr. to 7 Fr. Stepped

Dilator
Carrier

0.018” Guide wire 7 Fr. Introducer Dilator

7 Fr. Sheath with

hemostasis valve

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Sensation 7Fr. Fiber-Optic IAB Catheter
Catheter Tray

Catheter
Extracorporeal Tubing

Orange Fiber-Optic Cable

30cc Syringe with

One-Way Valve

Sensor
Connector

T- Handle

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Sensation 7Fr. Fiber-Optic IAB Catheter

Sensor Connector

Dust Cap:
Protects from Fluid and Dust Rubberized Grips

Electronic Prongs:
Identifies Sensor
to Pump

Tip of Fiber Strand

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Sensation 7Fr. Fiber-Optic IAB Catheter
Technical Specification

CatheterFeatures
Size and benefits 7Fr.
Balloon Size 34cc, 40cc
Balloon Membrane When Folded 7Fr.
Balloon Material Proprietary material / blow molded
Balloon Membrane Length 221mm (34cc), 258mm (40cc)
Balloon Membrane Diameter 15mm
Catheter Insertable Length 71.4cm
Catheter Shaft Design Co-lumen/Co-extruded
Catheter Shaft Material Polyurethane/Polyimide
Arterial Pressure Lumen Diameter 0.020“
Guidewire 0.018“ and 0.035“
Sheath Size 7 Fr.
Catheter Extender 183cm / 6 feet (34cc,40cc)

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IAB Catheter Sizing Guidelines

Note: This information is to be used as a guidance only. Clinical information and patient factors such as torso length should
be considered when selecting the appropriate balloon size. SENSATION and SENSATION PLUS are fiber-optic IAB catheters.
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56
SENSATION 7Fr. IAB Catheter
Marketing Literature

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MEGA® IAB Catheters

Higher Efficacy for Every Patient

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MEGA IAB Catheters
Product Overview

MEGA – Greater hemodynamic support and higher efficacy for every patient

• MEGA 8Fr. 50cc IAB catheter launched in 2009

• MEGA 7.5Fr. 30cc and 40cc IAB catheters introduced in 2012
• Superior blood volume displacement for everyone, at any height
• Two STATLOCK® devices included

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MEGA IAB Catheters

Product Overview and Positioning

• Larger volume balloons like MEGA

provide greater hemodynamic support
and higher efficacy
• One complete IAB family for all patient
heights
• NEW sizing guidelines for easier IAB
selection
• IAB therapy as the “first choice” of
treatment when hemodynamic support
is needed

MEGA: Greater hemodynamic support and higher efficacy for every patient.

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MEGA IAB Catheters
Key Features and Benefits

• Greater hemodynamic support

• Two STATLOCK® devices included (optional)
• Proprietary membrane
• Advanced IAB catheter design

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MEGA IAB Catheters

Greater Hemodynamic Support*

• More blood volume displacement

• More diastolic augmentation
• More systolic unloading

* Bench testing completed by Maquet. Data on file. Bench test results are not necessarily predictive of clinical results.
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MEGA IAB Catheter
STATLOCK® IAB

• Eliminates suture needle stick injuries

• Eliminates suture wound complications
• Enhances patient comfort and safety
• Quick and easy application and
removal

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MEGA IAB Catheters

Proprietary Membrane*

• 43% more abrasion resistance

• Reduced insertion force
• Immediate inflation at start-up

* Bench testing completed by Maquet. Data on file. Bench test results are not necessarily predictive of clinical results.
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60
MEGA IAB Catheters
Advanced IAB Catheter Design

• No step-down due to unique balloon

wrap
• Co-lumen design for optimal gas
passage
• Large 0.027” inner lumen for reliable Co-lumen Design
pressure transducer signal

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MEGA IAB Catheter

Technical Specifications

30cc 40cc 50cc

Patient Height < 5’0” 5’0” to 5’4” 5’4” & taller
(< 152cm) (152-162cm) (≥ 162cm)
Catheter/Sheath Diameter 7.5Fr. 7.5Fr. 8Fr.

Balloon Diameter 16mm 16mm 17.4mm

Balloon Length 178mm 229mm 258mm

Guidewire 0.025” 0.025” 0.025”

Inner Lumen 0.027” 0.027” 0.027”
Catheter Extender 5’6” / 168 cm 5’6” / 168 cm 5’7” / 170 cm

Insertable Length 72.3cm 72.3cm 72.3cm

Catheter Shaft Design Co-lumen/Co-extruded Co-lumen/Co-extruded Co-lumen/Co-extruded

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61
IAB Catheter Sizing Guidelines

Note: This information is to be used as a guidance only. Clinical information and patient factors such as torso length should
be considered when selecting the appropriate balloon size. SENSATION and SENSATION PLUS are fiber-optic IAB catheters.
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MEGA IAB Catheters

Packaging

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62
MEGA IAB Catheters

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MEGA IAB Catheters

IAB Catheter Tray
STAT-GARD Sleeve
Extracorporeal Tubing
Stylet Y-fitting Universal Sheath Seal

T-Handle Retainer 30 cc syringe with

one-way valve Catheter
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63
MEGA IAB Catheter
IAB Insertion Kit
4’ Pressure Tubing 4.5Fr. to 7.5Fr. 18 gauge
and Luer Cap Catheter Extender Vessel Dilator Angiographic Needle

3-way
Stopcock

4’ Pressure
0.025” Guidewire Introducer 7.5Fr. Sheath with
Tubing
Dilator hemostasis valve
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MEGA vs. Linear IAB Catheters

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64
MEGA IAB Catheters
Key Features and Benefits

Greater Hemodynamic Support

Feature Benefits What does this mean for

customers/patients?
Larger volume  More blood volume displacement  Greater hemodynamic
balloons  More diastolic augmentation support for every patient
(30cc, 40cc, 50cc)  More systolic unloading

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MEGA IAB Catheters

Key Features and Benefits

STATLOCK IAB

Feature Benefits What does this mean for

customers/patients?
STATLOCK IAB • Convenience of availability • Saves the clinician time
Stabilization Device
included in the box
• Needle-free securement of IABs • Eliminates suture-
securement needle sticks
and suture-wound
complications
• Patient comfort and safety
• Quick and easy application
and removal

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MEGA IAB Catheters
Key Features and Benefits

Proprietary Membrane

Feature Benefits What does this mean for

customers/patients?
Proprietary • 43% more abrasion resistance • Reduction in balloon leaks
Membrane • Reduced insertion force • Easier to insert balloon
• Immediate inflation at start-up • Faster time to therapy

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MEGA IAB Catheters

Key Features and Benefits

Advanced IAB Design

Feature Benefits What does this mean for

customers/patients?
Advanced IAB  No step-down due to unique  Potentially reduces risk of
design balloon wrap bleeding with sheathless
insertion
 Allows for smaller catheter
and sheath size which
optimizes distal limb flow
 Co-lumen design for optimal gas  Optimizes helium shuttle
passage area speed
 Delivers a reliable pressure
 Large 0.027” inner lumen
transducer signal

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66
MEGA IAB Catheters
Sizing Guidelines

Why are the New sizes better for patients?

• Larger volume balloons displace more

blood volume in aorta during diastole
• Result: improved augmentation and
unloading

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New Sizing Guidelines

MEGA IAB Safety

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MEGA IAB Catheters
Sizing Guidelines

Supporting Data

Hemodynamic Effects of Standard Versus Larger-Capacity

Intraaortic Balloon Counterpulsation Pumps
Authors: N. Kapur, MD, et. al.

Enhanced Augmentation of Cardiac Output for Different

Counterpulsation Modes Using a New Intra-Aortic Balloon and
Catheter
Authors: C. Boiangiu, MD and M. Cohen, MD

Improvement in Hemodynamics with a New, Larger-Volume

(50 cc) Intra-Aortic Balloon for High-Risk Percutaneous
Coronary Intervention
Authors: P.K. Nair, MD; S. Scolieri, MD; A.B. Lee, MD

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MEGA 30cc IAB Catheter

Bench Testing

MEGA 30cc - Greater Hemodynamic Support*

50%

45% 44%

40%

35%

30%
% increase in

25%
30 vs. 25
support

20%
20%
16%
15%

10%

5%

0%
volume displacement systolic unloading augmentation area

* Bench testing completed by Maquet. Data on file. Bench test results are not necessarily predictive of clinical results.
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MEGA 40cc IAB Catheter
Bench Testing

MEGA 40cc – Greater Hemodynamic Support*

20%
18%
18%

16%

13%
14%
% increase in

12%
support

10%
9%
40 vs. 34
8%

6%

4%

2%

0%
volume displacement systolic unloading augmentation area

* Bench testing completed by Maquet. Data on file. Bench test results are not necessarily predictive of clinical results.
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MEGA 50cc IAB Catheter

Bench Testing

MEGA 50cc - Greater Hemodynamic Support*

70%

58%
60%

50%
% increase in

40%
support

50 vs. 40
30%
25%

20%
15%

10%

0%
volume displacement systolic unloading augmentation area
* Bench testing completed by Maquet. Data on file. Bench test results are not necessarily predictive of clinical results.
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69
MEGA IAB Catheters
Product Strategy

All customers should be using a higher efficacy balloon because of the greater
hemodynamic support it provides to the patient

BIG BALLOONS are BETTER!!

Better…for the patient
Better…to take away business from our
competitors
Better…to help us meet our business
objectives

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MEGA IAB Catheters

Product Strategy

• Promote higher efficacy balloons to provide greater hemodynamic support

for every patient
• Continue to be the “first choice” of treatment when hemodynamic
support is needed for our cardiac patients
• Increase utilization and market share

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MEGA IAB Catheters
Targeting

MEGA 8Fr. 50cc customers LINEAR customers

• Familiar with hemodynamic benefits • Greater hemodynamic support for all
patients
• Complete family for all patient heights
• Two STATLOCK IAB devices in the box
• Easier solution for IABs on the shelf
• Two STATLOCK IAB devices in the box

Competitive accounts
• One IAB family provides greater hemodynamic
support for all patients
• Premium proprietary membrane
• Two STATLOCK IAB devices in the box
• Can be used with any Maquet or Arrow IABP

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MEGA IAB Catheter

Marketing Literature

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71
SENSATION PLUS®
Fiber-Optic IAB Catheter
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SENSATION PLUS Fiber-Optic IAB Catheter

Key Features

SENSATION PLUS is a Fiber-Optic IAB Catheter

PLUS Greater Hemodynamic Support

PLUS Improved Ease of Use

PLUS Improved Patient Comfort

= SENSATION PLUS IAB Catheter

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SENSATION PLUS Fiber-Optic IAB Catheter
Product Overview

SENSATION PLUS is a
PLUS to our current SENSATION Fiber-optic IAB catheter and a
PLUS to our MEGA IAB Catheter
Providing
• Greater Hemodynamic Support
• Improved Ease of Use
• Improved Patient Comfort

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SENSATION PLUS Fiber-optic IAB Catheter

Product Overview

• Fiber-optic technology
• 40 and 50cc membrane size
• 40cc 7.5 Fr. catheter design
• 50cc 8Fr. catheter design
• One guidewire to insert both sheath and
catheter (0.025”)
• Two STATLOCK IAB included in the IAB box

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SENSATION PLUS Fiber-Optic IAB Catheter

Fiber-Optic Technology
• Faster time to therapy
• In vivo calibration
Greater Hemodynamic Support
• 50cc vs. 40cc for patients 5’4” (162cm) and taller
• 25% more blood volume displacement 40cc vs. 50cc
• 18% more blood volume displacement 34cc vs. 40cc
• Improved unloading and augmentation
Ease of Use
• One guidewire
STATLOCK IAB Stabilization Devices
• 2 STATLOCK IABs inside the box

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SENSATION PLUS Fiber-Optic IAB Catheter

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SENSATION PLUS Fiber-Optic IAB Catheter
IAB Catheter Tray
Extracorporeal tubing STAT-GARD sleeve
Fiber-optic cable Y-fitting Sheath seal

T-Handle retainer 30cc syringe with Catheter

one-way valve
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SENSATION PLUS Fiber-Optic IAB Catheter

Insertion Kit Tray

Catheter extender with Introducer dilator

tubing clips Sheath with
Luer cap hemostasis valve

Carrier

18 gauge
needle

Pressure Tubing 3-way 0.025” x 145cm

Vessel dilator
stopcock guidewire
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SENSATION PLUS Fiber-Optic IAB Catheter
Technical Specifications

40cc 50cc

Patient Height 5’0” to 5’4” (152-162cm) 5’4” & taller (≥ 162cm)

Catheter/Sheath Size 7.5Fr. 8Fr.
Balloon Diameter 16mm 17.4mm
Balloon Length 229mm 258mm
Guidewire 0.025” 0.025”
Inner Lumen 0.027” 0.027”
Extender Tubing 6’ (183 cm) 5’7” (170 cm)

Insertable Length 72.3cm 72.3cm

Catheter Shaft Design Co-lumen/Co-extruded Co-lumen/Co-extruded

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SENSATION PLUS Fiber-Optic IAB Catheter

Sensation vs. Sensation Plus

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76
IAB Catheter Sizing Guidelines

Note: This information is to be used as a guidance only. Clinical information and patient factors such as torso length should
be considered when selecting the appropriate balloon size. SENSATION and SENSATION PLUS are fiber-optic IAB catheters.
QLT - Sales – IAB Catheters ML-0580-02 Rev B
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SENSATION PLUS Fiber-Optic IAB Catheter

Features and Benefits

Fiber-Optic Technology

Features Patient Benefits

Faster time to therapy • Faster and easier process for clinicians to bring
hemodynamic support to patient
Automatic in vivo calibration • No longer need to zero prior to insertion

Instantaneous signal transmission • Reduced signal transfer delay vs. fluid-filled

Crisp, clean arterial pressure
waveform
Low-level output capability
column
• Allows for fast response to rate and rhythm
changes
• Advanced tip design and reduced signal artifact
• Arterial pressure waveform not affected by
electrosurgical interference or patient movement
and positioning
• Allows for the ability to send the fiber-optic signal
to patient monitor

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SENSATION PLUS Fiber-Optic IAB Catheter
Features and Benefits

Greater Hemodynamic Support

Features Patient Benefits

Greater Hemodynamic Support • 25% more blood volume displacement

50cc vs. 40cc for patient > 5’4”(162cm) • 18% more blood volume displacement
40cc vs. 34cc for patient 5’-5’4” (152-162 cm)
Improved unloading and augmentation* • 15% more diastolic augmentation
50cc IAB SENSATION PLUS IAB • 58% more systolic unloading

40cc IAB SENSATION PLUS IAB • 9% more diastolic augmentation

• 13% more systolic unloading
Proprietary Membrane* • Balloon material would better withstand
abrasion and fatigue resistance to
continually deliver the therapy
• 43% abrasion resistance
• Improved fatigue resistance
• Immediate inflation at start-up

*Bench testing completed by Maquet. Data on file. Bench test results are not necessarily predictive of clinical results.
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SENSATION PLUS Fiber-Optic IAB Catheter

Features and Benefits

Ease of Use

Features Patient Benefits

One guidewire (0.025”) for sheathed • One guidewire for inserting the sheath and the
IAB catheter insertion IAB catheter
• No need to exchange wires
• Ease of use and faster time to therapy

0.027” internal diameter for pressure • Larger central lumen to provide clean arterial
monitoring if needed pressure signal, if needed
• Suitable for 0.025” guidewire
SENSATION 8Fr. Catheter 50cc IAB • 8Fr. catheter inserted through 8Fr. sheath or
Catheter sheathless
SENSATION PLUS 7.5Fr. 40cc IAB • 7.5Fr. catheter inserted through 7.5 Fr. sheath or
Catheter sheathless

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SENSATION PLUS Fiber-Optic IAB Catheters
Features and Benefits

STATLOCK IAB Stabilization Device

Features Patient Benefits

Provides custom designed • Sutureless securement

STATLOCK retainer for needle-free • Streamlines insertion process
securement of Maquet IABs
Eliminates suture-wound • Designed to provide patient comfort and
complications (ie. bleeding, infection) safety

100% elimination of suture- • Designed for staff safety

securement needlesticks

Offers skin safe STATLOCK adhesive • Allows for quick and easy application and
system removal
Two STATLOCK IABs in the box • Ease of use and convenience of having the 2
STATLOCK IABs inside the box

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SENSATION PLUS IAB Catheters

Marketing Literature

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79
Maquet IAB Catheters
Additional Marketing Literature

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Thank You!

www.getingegroup.com

Getinge Group is a leading global provider of innovative solutions for operating rooms,
intensive-care units, hospital wards, sterilization departments, elderly care and for life
science companies and institutions. With a genuine passion for life we build quality and
safety into every system. Our unique value proposition mirrors the continuum of care,
enhancing efficiency throughout the clinical pathway. Based on our first-hand
experience and close partnerships, we are able to exceed expectations from
customers – improving the every-day life for people, today and tomorrow.

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Qualified Level Training
IABP Consoles

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Counterpulsation Market History

2016

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Maquet IABP Consoles
CARDIOSAVE® / CS300™ / CS100®

Intra-aortic Balloon Pump Launch

• CARDIOSAVE 2011

• CS300 2007

• CS100 2003

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Intra-Aortic Balloon Counterpulsation

40 Years of Innovation

Video history of IABPs

click to play
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Triggering and Timing

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Trigger and Timing

Synchronization with the Cardiac Cycle
ECG Trigger Event – R wave
IAB Inflation - Diastole

Trigger Event Electrocardiogram

TRIGGER

Dicrotic Notch

Arterial Pressure

TIMING
IAB Inflated

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IAB Timing

A = One cardiac cycle

D Increased Coronary Artery
Perfusion B = Unassisted End Diastole

C C = Unassisted Systole
F
D = Augmented Diastole
E = Assisted End Diastole
Dicrotic
Notch F = Assisted Systole

B Reduced Myocardial
E O2 Demand
A

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IABP Triggers

• A Trigger is the signal that MAQUET IABP uses

to identify the beginning of the next cardiac
cycle

• When MAQUET IABP recognizes the trigger

event, it will deflate the balloon if not already
deflated

• ECG and Pressure trigger available in Auto

Operation

• All triggers available in Semi Auto Operation

CARDIOSAVE CS300

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IABP Triggers
ECG Trigger

Trigger Event
• R-Wave

Applications
• Preferred trigger (must have reliable
R-Wave)
• Recommended for patients with
arrhythmias
• Recommended for paced rhythms
(demand or asynchronous pacing)

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IABP Triggers
Pressure Trigger

Trigger Event
• Systolic upstroke of arterial waveform

Applications
• Backup trigger when ECG trigger is
not appropriate
• Reoccurring ECG artifact
• Electrocautery interference in OR
• Low voltage R-Wave
• Cardiac arrest/CPR

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IABP Triggers
Pacer V/AV Trigger

Trigger Event
• Ventricular pacer spike

Applications
• Used with V or AV paced rhythms
• Used when 100% paced and NO
reliable R-Wave
• Low voltage R-Wave
• Only available in Semi-Auto
operation mode

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IABP Triggers
Pacer A Trigger

Trigger Event
• R-Wave

Applications
• If pacer tails are present, IABP may
trigger inappropriately on the pacer tail
instead of the R-Wave (in ECG trigger)
• Primarily used in open heart patients
who have a temporary atrial pacemaker
• Never use Pacer A trigger in the
presence of a ventricular paced rhythm
• Only available in Semi-Auto operation
mode

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IABP Triggers
Internal Trigger

Trigger Event

• Asynchronous
• Balloon inflates/deflates at a set rate of 80 BPM
• Internal rate is adjustable

Applications

• Only use when patient is not generating a cardiac

output on their own
• Cardiac arrest
• Cardiopulmonary bypass
• Only available in Semi Auto operation mode

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Operation Modes
Auto and Semi Auto Operation
Name, title
Date
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CARDIOSAVE / CS300 / CS100
Auto vs. Semi Auto Operation

Auto Operation Semi Auto Operation

Automatic lead & trigger selection Operator selects the trigger source – all
trigger selections available
Automatic inflate & deflate timing Operator establishes initial timing

CardioSync 2 with R-Trac Software algorithms automatically track

changes in patient heart rate or rhythm and
adjusts timing – Cardiosync2 with R-Trac

User option to fine-tune deflation timing Operator can fine tune inflation and deflation
timing
Fiber-optic pressure sensor capability Fiber-optic pressure sensor capability
(CARDIOSAVE / CS300) (CARDIOSAVE / CS300)

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Auto Operation Design Goals

Provide optimal therapy with less user intervention by automatically and continually
monitoring and adjusting triggers and timing like an experienced user.

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CARDIOSAVE / CS300 / CS100
Auto Operation Features and Benefits
Features
Automatic lead & trigger selection
Automatic inflate & deflate timing
CardioSync 2 with R-Trac
User option to fine-tune deflation timing
Fiber-optic pressure sensor capability
(CARDIOSAVE / CS300)
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CARDIOSAVE / CS300 / CS100
INTELLISENSE™ and INTELLISYNC™ Software
Auto Operation – INTELLISENSE
Automatic lead and trigger selection
Automatic inflation and deflation timing
CardioSync2 with R-Trac
User option to fine-tune deflation timing
Additionally:
Fiber-optic pressure sensing capability
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Benefits
Reduces the need for user intervention in
the OR and in patients with unstable signals.
Less time needed by user to reconfirm
timing. Standardizes patient timing across
usage base.
Provides greater support in presence of
isolated PVC’s, ectopic patterns, A-Fib and
sudden rate or rhythm changes.
Incorporates user’s experience into therapy
delivery, not locking user out.
Reliable pressure monitoring
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MCV00039868 REV A
Auto Operation - INTELLISYNC
Automatic lead and trigger selection
Automatic inflation and deflation timing
CardioSync2 with R-Trac
User option to fine-tune deflation timing
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CARDIOSYNC2 with R-Trac™
Auto R Wave Deflation

Auto R-Wave deflation:

• Patented surveillance algorithm to identify unpredictable rhythms such as
atrial fibrillation
• Auto R-Wave Deflate automatically selected by R-Trac™ when complex
irregular rhythms prohibit the accurate prediction of the next cardiac cycle.
• R-Trac adjusts timing on a beat-to-beat basis to optimize augmentation and
support during diastole
• Simplest of deflation control methods:
• No need to anticipate the next cardiac cycle
• Deflate occurs immediately upon detection of next R-Wave
• Deflate method benefits from fast pneumatics

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Auto Operation
Automatic Lead and Trigger Selection

Automatic lead and trigger selection is designed to select the most appropriate
ECG lead and blood pressure signal from the available sources for display on the
monitor and to synchronize assist

Three Major Components

• ECG source manager
• Blood pressure source manager
• Trigger source manager

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Auto Operation
ECG Source Manager

• Preferred Source
• Skin leads directly connected to the IABP

• Total Available Sources

• Leads I, II, and III
• External ECG input (if interfaced from external monitor)

• Remain in current lead unless “Poor”

• (i.e.: noisy, inconsistent R-wave amplitude, etc.)

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Auto Operation
Blood Pressure Source Manager

• Preferred Source
• Direct / Transducer

• Available Sources
• Fiber-optic pressure signal
• Arterial pressure transducer
• External pressure input (if interfaced from external monitor)

Note: The fiber-optic pressure sensor takes precedence over an arterial pressure
transducer, as the direct pressure source. The fiber-optic pressure sensor must be
disconnected to use the pressure transducer.

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Auto Operation
Blood Pressure Source Manager

No source change unless loss of trigger is sustained

(for example: zeroing, flushing, or low pulsatility >8 seconds) \
or signal becomes unavailable.

System checks the suitability of the pressure transducer source during the Autofill
period if the external input is being used.

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Auto Operation
Trigger Source Manager

Trigger modes available in Auto Operation

• ECG Trigger
• Pressure Trigger

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Auto Operation - Trigger Source Manager
ECG to Pressure Trigger Change Criteria

• If loss of lead / ECG cable and no alternate lead available– Changes

immediately
• If loss of trigger for > 8 seconds – Changes to if no other ECG trigger available
• If all available ECG signals are noisy – Changes if no clear ECG signal in other
leads or from external source
• If 5 lead changes within 4 Min.
• If pacers are interfering with reliable R-wave detection – Changes to Pressure
trigger within 1-4 minutes (CS300, not applicable to CARDIOSAVE)
• ESU (electro surgical unit) noise detected
• Single ESU activation >4 seconds
• 2 ESU activations within 10 seconds

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Auto Operation - Trigger Source Manager

ECG to Pressure Trigger Change

Lead fault to Pressure Trigger

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Auto Operation - Trigger Source Manager
ECG to Pressure Change

Noisy ECG to Pressure to Pressure Trigger

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Auto Operation - Trigger Source Manager

ECG to Pressure Trigger Change Criteria

SCENARIO TIME TO CHANGE TO PRESSURE TRIGGER

Lead Fault Changes Immediately

Low Amplitude 8 Seconds if no other ECG trigger available

Noisy ECG 10 – 40 Seconds

Lead Changes 5 Leads in 4 Minutes

ESU (electro-surgical unit) Single ESU activation >4 seconds

Noise 2 ESU activations within 10 seconds
1.5 – 4 Minutes (CS100/CS300)
Pacer interference Not applicable to CARDIOSAVE due to improved pacer
detection.

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Trigger Source Manager
Pressure to ECG Trigger Change Criteria

• If B.P. cable is disconnected – immediately changes to ECG trigger if ECG

available

• If ECG is connected/reconnected & ECG is “clean” returns to ECG trigger within

15 seconds

• If trigger is lost for > 8 Sec. - due to flushing, zeroing or low BP pulse height, &
ECG is “clean” – returns to ECG trigger immediately

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Trigger Source Manager

Pressure to ECG Trigger Criteria

If Reason for Being in Pressure Trigger is:

Not Due to ESU Noise Due to ESU Noise

2 Minutes 5 Minutes
Regular
Rhythm is:

(typical case) (limited to O.R.)

1 Minutes
Irregular 1 Minute
(limited to O.R.)

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Trigger Source Manager
Pressure to ECG Trigger

Pressure to ECG TriggerQLT - Sales - IABP Consoles ML-0580-03 Rev A

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Auto Operation
Inflation / Deflation Timing

The system regularly examines and analyses key landmarks and events on both
assisted and unassisted beats to confirm and adjust timing accuracy.

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Auto Operation
Inflation Timing

• Inflation automatically set to begin at

the dicrotic notch Trigger Electrocardiogram
Event
• CardioSync2 with R-Trac adjusts timing TRIGGER
beat-to-beat to manage cardiac
rhythms and heart rate changes Dicrotic Notch

• Timing control models are updated a Arterial

Pressure
minimum of once every 3 minutes in TIMING
IAB Inflated
ECG trigger.

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Auto Operation
Deflation Timing

Deflation of the IAB prior to onset of ventricular ejection.

• System establishes deflation timing in Auto Operation
• User can fine tune deflation timing in Auto Operation – ECG Trigger
• No user fine tuning of deflation timing in Pressure Trigger

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Semi Auto Operation Mode

Semi Auto Operation

Operator selects the trigger source – all
trigger selections available

CARDIOSAVE CS300

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Semi Auto Operation Mode

Semi Auto Operation

Operator selects the trigger source – all Trigger Event Electrocardiogram
trigger selections available TRIGGER

Operator establishes initial timing Dicrotic Notch

Arterial
Pressur
TIMING e
IAB Inflated

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Semi Auto Operation Mode

Semi Auto Operation

Operator selects the trigger source – all trigger selections available

Operator establishes initial timing

Software algorithms automatically track changes in patient heart rate or rhythm and adjusts
timing – Cardiosync2 with R-Trac

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Semi Auto Operation Mode

Semi Auto Operation

Operator selects the trigger source – all
trigger selections available

Operator establishes initial timing

Software algorithms automatically track

changes in patient heart rate or rhythm and
adjusts timing – Cardiosync2 with R-Trac
Operator can fine tune inflation and deflation
timing

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Semi Auto Operation Mode

Semi Auto Operation

Operator selects the trigger source – all trigger selections available

Operator establishes initial timing

Software algorithms automatically track changes in patient heart rate or rhythm and adjusts
timing – Cardiosync2 with R-Trac

Operator can fine tune inflation and deflation timing

Fiber-optic pressure sensor capability (CARDIOSAVE / CS300)

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Pneumatics

Name, title
Date
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Pneumatic System

Safety Disk
Condensate Removal System
Compressor - Pressure / Vacuum

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Safety Disk

CS300/CS100 Safety Disk

CARDIOSAVE Safety Disk

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101
Safety Disk

Flexible Isolation
Membrane
(Diaphragm)

Drive Port
pressure and vacuum Shuttle Gas Port – IAB
from compressor Air catheter connection

Helium gas to
patient IAB
He
catheter

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Safety Disk – Internal View

CARDIOSAVE

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Safety Disk – Internal View
CS300 / CS100

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Condensate Removal
CARDIOSAVE

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Condensate Removal
CS300 / CS100

• Peltier Cooler
• Power Supply
• Drain Port

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Pneumatics
Compressor

Role of the compressor is to generate drive pressure and vacuum needed to

operate the safety disk

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Compressor
CARDIOSAVE

New Scroll Compressor (Feature)

Air is moved along a continuous spiral path
Attributes (Benefits)
• Sound deadening enclosure not required
because there is less vibration – smaller,
lighter & quieter
• Less energy required to drive
compressor
• Motor speed ramps up or down based
on changes in heart rate, allowing for
optimization of power consumption
The Drive Side
Scroll Compressor

Example of a scroll compressor in action (internet access needed to view)

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Compressor
CS300 / CS100

Dual Head Reciprocating Compressor

Air is moved during a
compression/decompression cycle
Attributes
• Requires sound deadening enclosure
due to vibration - affects size, weight &
noise
• Takes more energy to drive
• Motor only has 2 speeds – AC power &
Battery power

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CARDIOSAVE

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CARDIOSAVE
More than a pump. A Revolution

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CARDIOSAVE
Product Offering

CARDIOSAVE hybrid CARDIOSAVE rescue

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CARDIOSAVE hybrid

Easily converts from hospital configuration

to transport configuration

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CARDIOSAVE rescue

Designed specifically for transport use

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CARDIOSAVE
Intelligent Automation

Simply press one-button to initiate therapy

• Automatically evaluates and selects the best lead and trigger source

• Automatically sets optimal timing

• Automatically adjusts to changes in patient conditions without clinician

intervention

• Automatically calibrates the fiber-optic pressure sensor inside the patient and
recalibrates every 2 hours or sooner should patient or environmental conditions
change*

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CARDIOSAVE
Monitor and Touchscreen

Improved user interface for ease-of-use

• Backlit monitor display
• Backlit touchscreen control
• Improved help screen navigation
• Lock screen feature

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CARDIOSAVE
Monitor

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CARDIOSAVE
Touchscreen

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CARDIOSAVE

Improved patient interconnects for ease-of-use

• Better organized patient interface

connections

• Easier access to connection panel

• Color coded and keyed connections

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CARDIOSAVE hybrid

Improved user convenience attributes

• Self retracting power cord

• 2 hot-swappable lithium ion batteries

• Out-of-sight helium tank compartment

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CARDIOSAVE

Improved physical characteristics for inter-facility transports

• Lighter weight
• Only 53 lbs. in transport configuration
• Only 114 lbs. in hospital configuration
• Smaller size

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CARDIOSAVE rescue

Interchangeable Lithium Ion Batteries

• 90 minutes typical run time per pack, with full charge

• Weight (per pack)
• 1.4 kg
• 3 lbs.
• 80% lighter than current lead acid battery
• Hot-swappable for virtually unlimited run time

All weights ± 5%
Weight comparison is with 2 Lithium Ion Batteries vs. current CS300 lead acid battery
Additionally, the ability to “hot swap” batteries allows virtually unlimited battery run time capability and
allows patients who are being supported by the pump in one facility to be easily transported to another
without any interruption in support regardless of the length of transport.
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CARDIOSAVE

Enhanced algorithms for easier

management of the most complex patients

• Enhanced pacer detection

• More sophisticated management of lead

faults

• Advanced triggering performance

Quieter for patient comfort

• Significantly quieter when compared to

earlier generation MAQUET IABPs

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CARDIOSAVE
Project Goals

Overall Product Goals

• Familiar appearance with new attributes
• Equal or better performance to current IABPs
• Improved user interface
• Improved transport attributes
Production & Service Goals
• Better manufacturability & serviceability
• Extended service interval
• Utilize latest technology components

First fully MAQUET branded IABP

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CARDIOSAVE
Design Objectives

Provide equal or better performance to

current products except:
• More Intuitive
• Smaller
• Lighter
• Quieter
• More Efficient

Unique new design:

• User Interface
• External Package
• Pneumatics
• Electronics
• Software
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CARDIOSAVE
Features and Benefits

Improved user interface for ease of use

• Larger upper display
• New touch screen control
• Improved help screen navigation

Improved functionality for increased

performance
• Enhanced pacer detection
• More sophisticated management of lead
faults
• Improved tall T-wave rejection

Lighter for better maneuverability

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CARDIOSAVE
Features and Benefits

Improved patient interconnects for

ease of use
• Better organized patient interface
connections
• Easier access to connection panel
• Color coded and keyed connections
Quieter for patient convenience
• Significantly quieter when compared to
CS300
Improved user convenience attributes
• Self retracting line cord
• Convenient access and out-of-sight helium
tank compartment

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CARDIOSAVE
Features and Benefits

Improved attributes for better inter-facility

transports

• Lighter weight - approximately 1/2 weight of

CS300UTS

• Smaller size - approximately 1/3 size of

CS300UTS

• Hot swappable lithium ion batteries - potential

unlimited run time with spare batteries

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CARDIOSAVE hybrid
Physical Characteristics

WEIGHT1 Kilograms Pounds

Monitor 3.62 7.97

2 Battery Packs 2.86 6.30

Cart (with helium tank) 26.80 59.00

Pump Console 17.20 38.00

Total 50.48 111.27

CS300 Reference 84.00 185.30

1 All weights ± 5%
2 All dimensions ± 5%. Dimensions include the Pneumatic Module
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CARDIOSAVE hybrid
Physical Characteristics

DIMENSIONS2 Height Depth Width

Centimeters Inches Centimeters Inches Centimeters Inches

Display Closed 111.80 44.00 68.60 27.00 55.90 22.00

Display Open 90° 134.60 53.00

1 All weights ± 5%
2 All dimensions ± 5%. Dimensions include the Pneumatic Module
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CARDIOSAVE rescue
Physical Characteristics

WEIGHT1 Kilograms Pound

Transport Module2 23.68 52.27

CS300 UTS Reference 61.40 135.30

1 All weights ± 5%
2 Includes transport module, display & 2 batteries
3,All dimensions ± 5%. Dimensions include the Pneumatic Module
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CARDIOSAVE rescue
Physical Characteristics

DIMENSIONS3 Height Depth Width

Centimeters Inches Centimeters Inches Centimeters Inches

Display Closed 57.20 22.50 40.60 16.00 33.00 13.00

Display Open 90° 78.00 30.70

1 All weights ± 5%
2 Includes transport module, display & 2 batteries
3,All dimensions ± 5%. Dimensions include the Pneumatic Module
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CARDIOSAVE hybrid

Conversion to transport configuration

Step 1 Step 2 Step 3

Un-latch & slide-out console Remove console from cart Affix monitor & extend handle

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CARDIOSAVE

• Designed for use with all current MAQUET IABs

• SENSATION Plus
• Sensation 7Fr
• MEGA
• LINEAR
• No pediatric capability

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CARDIOSAVE hybrid
Standard Accessories

Standard Accessories Qty

CARDIOSAVE Accessory Kit 1

Helium Tank(s) Current

CARDIOSAVE Battery Pack 2

CARDIOSAVE hybrid

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CARDIOSAVE rescue
Standard Accessories

Standard Accessories Qty

CARDIOSAVE Accessory Kit 1

Helium Tank(s) current

CARDIOSAVE Battery Pack 2

CARDIOSAVE Battery Charging

1
CARDIOSAVE rescue Station

CARDIOSAVE Helium Refilling Station 1

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CARDIOSAVE
Helium Supply

Designed for use with all current MAQUET/Datascope Helium Tanks

• 0075-00-0024-XX Reusable Helium Tank Global

• 0075-02-0001-01 Reusable Helium Tank - UK / France

• 0075-02-0002-01 Reusable Helium Tank – German

• 0202-00-0104 Disposable Helium Tank

• Ships separately from pump & accessories

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CARDIOSAVE
Battery Packs

• Battery Type 14.8 VDC (nominal), sealed, Lithium Ion, maintenance free

• Run Time: 60 Minutes Minimum, 120 bpm, 22 +/- 5 degrees C

90 Minutes Typical - new battery, 90 bpm, 22 +/- 5 degrees C

(per pack, with full charge)

• Recharge Time: 5 hours per pack to 90% or greater capacity

• FOR USE ONLY WITH CARDIOSAVE

• Ships separately from pump & accessories

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CARDIOSAVE IABP Trainer

Optional Accessories

• New connectors

• New package

• Increased functionality

FOR USE ONLY WITH CARDIOSAVE

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CARDIOSAVE AC Transport Power Supply
Optional Accessories

• Provides power to Rescue module from AC power source

• Identical package to battery

• Charges battery only when unit is powered off

• FOR USE ONLY WITH CARDIOSAVE

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CARDIOSAVE rescue Transport Accessories

Standard Accessories

• Battery Charging Station

• Helium Refilling Station

• FOR USE ONLY WITH CARDIOSAVE

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CARDIOSAVE rescue Transport Accessories
Optional Accessories

• Transport Mounting Plate

• FOR USE ONLY WITH CARDIOSAVE

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CARDIOSAVE
Accessory Kit Components

• CARDIOSAVE Blood Pressure Transducer

Adapter Cable
• CARDIOSAVE ECG Trunk Cable - 5 lead ECG
• CARDIOSAVE ESIS Lead Wires 50“ – 5 Lead
• External Signal Cable (current)
• Washer, Helium Cylinder (current)
• Chart Paper, Thermal Recorder (current)
• CARDIOSAVE Operators Manual

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CARDIOSAVE Languages

18 Languages at Full Market Release

Chinese Japanese Hungarian
Czech French Portuguese
Danish German Russian
Dutch Italian Spanish
English Norwegian Swedish
Finnish Polish Turkish

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CARDIOSAVE
Service Highlights

• 6 month preventive maintenance no longer

required under normal use

• New compressor technology yields longer

times between preventive maintenance

• 2,500 hour compressor preventive

maintenance kit no longer required under
normal use

• Improved cable management and sub-

assembly accessibility

• Smaller and lighter - easier to transport in

and out of service vehicle

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CARDIOSAVE Technical Features

Objective:
Side by side comparison of
CARDIOSAVE and CS300

CARDIOSAVE CS300
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CARDIOSAVE Technical Features

CARDIOSAVE CS300
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CARDIOSAVE Technical Features

CARDIOSAVE CS300

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CARDIOSAVE Technical Features

Pigtail Pressure Cable ECG Cable

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CARDIOSAVE Technical Features

CARDIOSAVE CS300

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CARDIOSAVE Technical Features

CARDIOSAVE CS300

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CARDIOSAVE Technical Features

CARDIOSAVE CS300
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CARDIOSAVE Technical Features

CARDIOSAVE CS300

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CARDIOSAVE Technical Features

CARDIOSAVE CS300

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CARDIOSAVE Technical Features

CARDIOSAVE CS300

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CARDIOSAVE Technical Features

CARDIOSAVE CS300

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CARDIOSAVE Technical Features

CARDIOSAVE CS300

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CARDIOSAVE Technical Features

CARDIOSAVE CS300

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CARDIOSAVE Technical Features

CARDIOSAVE CS300

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CARDIOSAVE Technical Features

CARDIOSAVE CS300

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CARDIOSAVE Technical Features

CARDIOSAVE CS300

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CARDIOSAVE Technical Features

CARDIOSAVE CS300
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CARDIOSAVE
Algorithmic and Pneumatic Enhancements

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CARDIOSAVE
Algorithmic and Pneumatic Enhancements

• Algorithmic Enhancements

• Pneumatic Enhancements

• Key Takeaways

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CARDIOSAVE
Algorithmic Enhancements

Introduction
• CARDIOSAVE‘S advanced front-end board design incorporates 2 state of the art
digital signal processing (DSP) engines
• Leveraging extensively upon new hardware architecture and DSP technology,
several significant enhancements were made to:
• Pacer Detection
• ECG Lead Fault Detection
• Triggering Performance

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CARDIOSAVE
Algorithmic Enhancements

Pacer Detection

Feature
• New ability to detect and analyze pacer spikes simultaneously
in multiple leads
Benefit
• Improves ability to identify pacer spikes

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CARDIOSAVE
Algorithmic Enhancements

Pacer Detection
Feature
• New pacer detection sensitivity adjustment via Touchscreen
• Increases sensitivity (ability) to detect pacer spikes – default
sensitivity is at 2 bars
• *Sensitivity can be increased to:
• 3 bars - increases nominal sensitivity by 50% (Direct) / 15% (Ext)
• 4 bars - increases nominal sensitivity by 75% (Direct) / 38% (Ext)
• *Sensitivity can be decreased to:
• 1 bar - decreases nominal sensitivity by 50% (Direct) / 38% (Ext)
Benefit
• Improves ability to identify pacer spikes
• Minimizes potential for pseudo pacer spikes

*Data on File.
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CARDIOSAVE
Algorithmic Enhancements

ECG Lead Fault Detection

Feature
• New ability to pinpoint which lead and/or electrode is “off” the patient
Benefit
• Potentially saves clinician time when trying to identify which lead and/or
electrode is “off” the patient

Displays “Faulted” if there

is no ECG waveform

Displays “Disconnected” if
there is an ECG waveform

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CARDIOSAVE
Algorithmic Enhancements

Triggering Performance
Feature
• Greater immunity to electro-surgical interference
Benefit
• Potentially minimizes need to switch from ECG Trigger to Pressure
Trigger in the OR

CS300

CARDIOSAVE

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CARDIOSAVE
Algorithmic Enhancements

Triggering Performance

Feature
• Lower threshold requirement for triggering in ECG Trigger (80uV)
- as opposed to 120uV with CS300
Benefit
• Improved ability to trigger with very low voltage ECG amplitudes,
allowing for elimination of manual ECG gain adjustment

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CARDIOSAVE
Algorithmic Enhancements

Triggering Performance

Feature
• Improved tall T-Wave rejection - associated with ischemic
myocardium
• T-Waves 120% of the R-wave height will be rejected – as
opposed to 70% with CS300
Benefit
• Pump less likely to trigger inappropriately on a tall T-Wave

Examples of Tall T-Waves

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CARDIOSAVE
Algorithmic Enhancements

Triggering Performance

Feature
• Increased pacer functionality with higher heart rates in Pacer
V/AV Trigger
• Manages both V & A-V pacing modes up to 180BPM - with
CS300, A-V triggering is limited to 125BPM
Benefit
• Improves range of triggering in Pacer V/AV Trigger

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CARDIOSAVE
Algorithmic and Pneumatic Enhancements

Additional Improvements:

Low-Level Output BP Signal Transmission

Feature
• New ability to send a conventional BP signal from pump to a patient
monitor - as opposed to only the fiber-optic signal with CS300
Benefit
• Gives clinicians more flexibility with external monitor interfacing

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CARDIOSAVE
Algorithmic Enhancements

Additional Improvements:

Augmentation Alarm
Feature
• Alarm limit is no longer forced to maximum when pressure
waveform does not permit analysis
• Learning interval increased to 3 minutes before Aug. Alarm is set
on start-up - as opposed to 1 minute with CS300
Benefit
• Potentially minimizes nuisance alarms
• Allows more time for hemodynamic stabilization before Aug.
Alarm is set

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CARDIOSAVE
Algorithmic Enhancements

Additional Improvements:

Switching Operation Modes

Feature
• Clinician does not need to press START after switching from
Semi-Auto to Auto, pumping starts automatically
Benefit
• Minimizes interruption of therapy
• Saves clinician a step

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CARDIOSAVE
Algorithmic Enhancements

Additional Improvements:

Unable to Calibrate Alarm

Feature
Improved management of the Unable to Calibrate Fiber-Optic Sensor alarm
decreases the interval that further calibrations are attempted
• One recalibration attempt after 5 minutes, then only with regularly scheduled
calibrations – as opposed to recalibration attempts every 15 minutes with
CS300
• Alarm only sounds briefly with each unsuccessful calibration – as opposed
to every 5 minutes with CS300
Benefit
• Potentially reduces amount of time therapy is paused for patient
• Reduces repetition of alarms

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CARDIOSAVE
Pneumatic Enhancements

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CARDIOSAVE
Pneumatic Enhancements

Pneumatic Design Goals

• Smaller
• Lighter
• Quieter
• Faster

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CARDIOSAVE
Pneumatic Enhancements

The Drive Side

Role of the Compressor

Generates drive pressure and vacuum needed to operate Safety Disk

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CARDIOSAVE
Pneumatic Enhancements

The Drive Side

CS300 – Dual Head Reciprocating

Compressor
Air is moved during a
compression/decompression cycle
Attributes
• Requires sound deadening enclosure
due to vibration - affects size, weight
& noise
• Takes more energy to drive
• Motor only has 2 speeds – AC power
& Battery power

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CARDIOSAVE
Pneumatic Enhancements

The Drive Side

CARDIOSAVE – New Scroll Compressor

(Feature)
Air is moved along a continuous spiral path
Attributes (Benefits)
• Sound deadening enclosure not required
because there is less vibration – smaller,
lighter & quieter
• Less energy required to drive compressor
• Motor speed ramps up or down based on
The Drive Side
changes in heart rate, allowing for
Scroll Compressor
optimization of power consumption

Example of a scroll compressor in action (internet access needed to view)

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CARDIOSAVE
Pneumatic Enhancements

The Drive Side

CS300 - Vent Valve

Activated with high heart rates to reduce vacuum demand from compressor,
resulting in noise that is noticeable to clinician

CARDIOSAVE - No Vent Valve (Feature)

Venting at high rates is no longer required due to speed controlled motor
Attributes (Benefits)
• Reduces noise, weight & power consumption

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CARDIOSAVE
Pneumatic Enhancements

The Fill Side

CS300 - Safety Disk

Constructed of aluminum

CARDIOSAVE - New Safety Disk (Feature)

Constructed of molded plastic
Attribute (Benefit)
• Lighter weight

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CARDIOSAVE
Pneumatic Enhancements

The Fill Side

CS300 - Condensate Removal Module

Utilizes a Peltier Cooler - converts water
vapor to liquid, then drips it into a cold trap.
Liquid is purged out of the system with each
Autofill

Attributes
• Consumes power
• Does not operate with low battery levels

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CARDIOSAVE
Pneumatic Enhancements

The Fill Side

CARDIOSAVE - New
Condensation Removal System
(Feature)
Utilizes NafionTM technology:
• As helium passes through a
Nafion tube, water vapor is
collected on the inside surface
• Water vapor is then
transferred across the surface
to another tube with
circulating air, which vents the
water vapor to atmosphere

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CARDIOSAVE
Pneumatic Enhancements

The Fill Side

CARDIOSAVE - New Condensation

Removal System
Attributes (Benefits)
• Continuous water vapor removal
from system with each
inflate/deflate cycle
• No need to convert water vapor
to liquid
• Consumes no power, smaller &
lighter weight
Nafion Tube

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CARDIOSAVE
Pneumatic Enhancements

The Fill Side

CS300 – Concealment
Attributes
• Safety Disk/CRM can potentially become
dislodged or work loose
• Fill and drain ports are exposed
CARDIOSAVE – Better Concealment (Feature)
Attributes (Benefits)
• Pneumatic Module cannot become dislodged or
work loose
• Fill and drain ports are not exposed, thus
cannot become disconnected

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CARDIOSAVE
Pneumatic Enhancements

The Fill Side

CS300 – Volume Fill System

• Deep vacuum is drawn on balloon and tubing to evacuate helium
• Calibrated cylinder is filled with fixed volume of helium
• Fixed volume is then drawn into Safety Disk

Attributes
• Scheduled Autofills occur every 2 hours
• Helium tank lasts for approximately 2 months of continuous
pumping

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CARDIOSAVE
Pneumatic Enhancements

The Fill Side

CARDIOSAVE – New Pressure Fill System (Feature)

• Old helium is vented to atmosphere
• System measures catheter and tubing volume, then calculates a targeted
fill pressure based on that volume
• Helium is added directly into Safety Disk until calculated fill pressure is
reached
• New Diffusion Replacement Cycle (DRC)
– Helium loss due to diffusion is replaced at midway point between each
2 hour Autofill
– Process takes < 1 second

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CARDIOSAVE
Pneumatic Enhancements

The Fill Side

CARDIOSAVE – New Pressure Fill System (continued)

Attributes (Benefits)
Scheduled Autofills occur every 2 hours
Helps to optimize volume displacement and diastolic augmentation
- due to Diffusion Replacement Cycle
Helium tank lasts for approximately 3 months of continuous
pumping
Requires less space - large calibrated cylinder is eliminated

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CARDIOSAVE
Pneumatic Enhancements

Maquet CARDIOSAVE and CS300 vs. Arrow AutoCAT2 WAVE

Combined Inflate/Deflate Speed (milliseconds)

Data based on bench-top testing and on file at Maquet.

All measurements completed using a MEGA 8 Fr. 50cc IAB under the same physical conditions.
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CARDIOSAVE
Pneumatic Enhancements

The Fill Side

CARDIOSAVE – Faster Pneumatic Speed!! (Feature)

• HR 80 – 10.0% faster than CS300 (normotensive pt.)*
• HR 150 – 16.4% faster than CS300 (normotensive pt.)*
• HR 80 – 24% faster than AutoCAT2 WAVE (normotensive pt.)*
• HR 150 – 26.7% faster than AutoCAT2 WAVE (normotensive pt.)*
Why is pneumatic speed faster?
Helium travels shorter and straighter path due to new Condensation
Removal System - less time from pump to catheter
Attribute (Benefit)
Helps optimize diastolic augmentation because balloon can stay inflated
longer during diastole

*Data on File.
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CARDIOSAVE
Pneumatic Enhancements

Key Takeaways

Enhanced Algorithms – Easier to manage the most complex patients

Enhanced pacer detection
More sophisticated management of lead faults
Advanced triggering performance

Enhanced Pneumatics - Innovative design for optimal performance in an

efficient package
Smaller, lighter, quieter & faster
Helps optimize volume displacement and diastolic augmentation
Conserves helium

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CS300 / CS100
Features and Benefits

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CS300
Monitor Screen

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CS300
Keypad

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CS100
Monitor Screen

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CS100
Keypad

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CS300 / CS100
Rear Panel

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CS300
Features and Benefits

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CS300
Design Principles of the CS300

INTELLISENSE combines fiber-optic speed and

automatic in vivo calibration with:
• Faster time to therapy
• Faster signal acquisition
• Faster adaptation to rate and rhythm
changes

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CS300
Design Principles of the CS300

The goal of the CS300 is to provide

optimal therapy with less user
intervention.

This is achieved by automatically and

continually monitoring and adjusting
triggers and timing as would an
experienced user.

This allows more time for the clinician to

focus on the patient.

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CS300 with Intellisense

Features and Benefits

True One-button Start-up:

• Automatically calibrates the fiber-optic
pressure sensor in the patient
• Automatically evaluates and selects
the best lead and trigger source
• Automatically sets optimal inflate and
deflate timing
• Automatically adjusts to changes in
patient conditions without clinician
intervention

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Maquet Fiber-Optic Technology

A fiber-optic pressure sensor is a very small manometer (pressure sensor) located

in the tip of the Sensation IAB catheter that transmits the signal by light through a
fiber-optic strand to the CS300.

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CS300 with Intellisense

Automatic In-vivo Calibration

MAQUET/Datascope has the ONLY fiber-
optic IABP and catheter system that
automatically calibrates in the patient
after insertion and automatically
recalibrates in vivo every 2 hours or
sooner if patient or environmental
conditions change.

The result: faster time to therapy, ongoing

consistency and accuracy of the arterial
blood pressure, and improved ease of
use.

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CS300
Features and Benefits

• Faster time to therapy

• One-button start-up.
• Faster inflation and deflation speed
• Fast balloon pump and superior catheter result in a fast inflate/deflate time
• Speed matters! For the patient, the benefit is an improvement in arrhythmia
tracking and response
• A smart timing algorithm matters
• CS300 with INTELLISENSE is designed to emulate an experienced user
• Allows clinician more time to focus on the patient
• System regularly examines key landmarks on the ECG and arterial pressure
waveform to determine optimal timing
• Adapts to rate or rhythm changes instead of imposing fixed timing rules

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CS300 with Intellisense

Low-level Pressure Output:

• Ability to transmit the fiber-optic
pressure waveform from the CS300
directly to a patient monitor
• A unique MAQUET/Datascope feature

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CS300 with Intellisense

Flexibility of Use:
• Sensation fiber-optic IAB
• Conventional fluid-filled catheters
• Remove console from cart for easy
transport
• UTS model specially designed for
transport

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CS300
New Alarm Structure

Visual and Audible alarms comply with IEC 60601-1-8 Alarm Standard

CS300 Alarm Messages CS100 Alarm Messages

Technical Informational Messages Technical Alarm Messages

High Priority Alarm Messages

Medium Priority Alarm Messages Alarm Messages
Low Priority Alarm Messages

Informational Messages Advisory Messages

Alarms look and sound differently than CS100

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CS300
Technical Alarms

Electrical Test Fails Code # _____

System Failure
No Patient Status Available

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CS300 Alarms / Informational Messages

High Priority Alarms

!!! • Red Icon Flashes
• Tone is two groups of 5 notes, repeated every 3 seconds until the
alarm is corrected.
• Located on the top line of the display.
Medium Priority Alarms
!! • Yellow Icon Flashes
• Tone is a group of 3 notes, repeated within 30 seconds until the
alarm is corrected.
• Location on one of three lines directly under the ECG waveform.
Low Priority Alarms
! • Steady (non-flashing) Icon
• Tone is a group of 2 notes, repeated every 30 seconds until the
alarm is corrected.
• Location on one of three lines directly under the ECG waveform.

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CS300 Alarms / Informational Messages

Informational Messages
• No icon
• Certain Informational Messages will have a “double beep” audio tone.
• Messages located on one of three lines directly under the ECG waveform

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CS300 Alarm Display

Single Line High

Priority Alarm
Message

Three additional
lines of Alarm and
Informational
Messages

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CS100
Features and Benefits

CS100 with INTELLISYNC

Introduced in 2003
First system with Auto and Semi Auto Operation
Auto Operation with INTELLISYNC
INTELLISYNC algorithms adapt to the unique needs of every
patient care environment
Full color monitor – easier to distinguish patient waveforms
Redesigned keypad with more intuitive user interface

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CS100
Features and Benefits

CS100 with INTELLISYNC

• Timing algorithms regularly examine key waveform

landmarks on both assisted and unassisted beats to
determine optimal timing.
• Sets inflation at the dicrotic notch and deflation at
start of systole
• Reacts quickly in the presence of rate or rhythm
changes and adjusts timing
• Lead and trigger sources are continuously evaluated
for quality
• Responds to changes in signal quality and selects
new trigger
• Ensures pump is always utilizing the best available
signal
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CS100
Features and Benefits

• Fast, one-button start-up and delivery of therapy

• Consistent support for patients with PVC’s and
arrhythmias
• Fast pneumatics
• Automatically troubleshoots and adapts
• Easier patient management
• Standardization of patient therapy
• Eliminates alarms due to ESU noise
• Reduced need for user intervention

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Thank you!

Getinge Group is a leading global provider of equipment and systems that contribute to quality enhancement
and cost efficiency within healthcare and life sciences. We operate under the three brands of Arjohuntleigh,
Getinge and Maquet.

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159
Qualified Level Training
®
STATLOCK IAB and PSI

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STATLOCK PSI Stabilization Device

Why not suture?

Sutures can Cause:

Wound Infections
Catheter-Related Bloodstream Infection (CRBSI)
Needle stick Injuries

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STATLOCK Stabilization Device
Standard of Practice and Guidelines

OSHA (Occupational Safety and Health Administration) Fact Sheet:

• “As part of their annual review of methods to reduce needle sticks, employers
must review options for securing medical catheters and consider appropriate
engineering and work practice controls.”

Infusion Nursing Society 2006 Standards of Practice:

• Use of a manufactured catheter stabilization device is preferred over other
methods

CDC (Centers for Disease Control) 2001 Guidelines:

• Use a sutureless securement device to reduce the risk of infection for
intravascular catheters
• Using a sutureless securement device also mitigates the risk of sharps injury to
the healthcare provider from inadvertent needle stick injury

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STATLOCK Stabilization Device

Safety Benefits

• Cost of treating blood stream infection as been estimated between $ 3,700 to

$ 29,000*
• Needle stick injury poses a significant risk to health care providers**

*Mermel, LA. Prevention of intravascular catheter-related infections. Ann Intern Med 200;132:391-402
**Patel N, et al. Device-specific sharps injury and usage rates: analysis by hospital departments. Am J Infec Control 1997;
25:77-84
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STATLOCK Stabilization Device
Safety Benefits

Sutureless Securement Device Reduces Complications

The Journal of Vascular and Interventional Radiology
Prospective, randomized study
170 participants - STATLOCK® vs. Suture

Bloodstream infections
2% (STATLOCK) vs. 12% (suture) p = 0.032
Needle stick injury
0% (STATLOCK) vs. 1.2% (suture)
Average securement time significantly
2.7min (STATLOCK) vs. 4.7 min (suture) p<.001

Yamamoto, AJ.,et al. Sutureless securement device reduces complications of peripherally inserted central venous
catheters. JVIR 13.1 (2002): 77-81.
QLT – Sales – STATLOCK IAB and PSI ML-0580-04 Rev A
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STATLOCK Stabilization Device

Journal of Infusion Nursing

• Publication reviews prospective

data comparing standard methods
of catheter securement with
securement device
• Data demonstrates securement
device significant y reduces overall
catheter-associated complications

Frey, Anne Marie, et al. Why Are We Stuck on Tape and Suture?: A Review of Catheter Securement Devices. Journal of Infusion
Nursing 29.1 (2006): 34-38.
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STATLOCK Stabilization Device

Frey, Anne Marie, et al. Why Are We Stuck on Tape and Suture?: A Review of Catheter Securement Devices. Journal of Infusion
Nursing 29.1 (2006): 34-38.
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STATLOCK Stabilization Device

Frey, Anne Marie, et al. Why Are We Stuck on Tape and Suture?: A Review of Catheter Securement Devices. Journal of Infusion
Nursing 29.1 (2006): 34-38.
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STATLOCK Stabilization Device

Frey, Anne Marie, et al. Why Are We Stuck on Tape and Suture?: A Review of Catheter Securement Devices. Journal of Infusion
Nursing 29.1 (2006): 34-38.

QLT – Sales – STATLOCK IAB and PSI ML-0580-04 Rev A

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Medical Sharp Injuries

Medical Sharp Injuries

• Approximately 10% of workers in the European Union are employed in the health
and welfare sector – a significant proportion employed in hospitals.
• Healthcare is one of the biggest employment sectors in Europe
• Women represent around 77% of the workforce
• European data indicates the work related accident rate in the healthcare sector
is 34% higher than the EU average
• The effects of injuries to staff from used hypodermic needs can be both physical
and emotional
• Bloodborne viruses such as HIV or hepatitis B or C can be passed on to the staff

Source: European Agency for Safety and Health at work FACTS Issue 29 - Safety and Health Good Practice for the Healthcare Sector (Online
Publication - ISNN 1681-2123)
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Medical Sharp Injuries
Medical Sharp Injuries

Preventative measures include:

• Eliminate the use of needles where safe and effective alternatives are available
• Implement the use of devices with safety features and evaluate their use to
determine which are most effective and acceptable
• Modify work practices that pose a needle injury hazard to make them safer
• Train works in the safe use and disposal of needles

Source: European Agency for Safety and Health at work FACTS Issue 29 - Safety and Health Good Practice for the Healthcare Sector (Online
Publication - ISNN 1681-2123)
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STATLOCK Intra-aortic Balloon

®

(IAB) Stabilization Device

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STATLOCK IAB Stabilization Device
Product Overview

Description
The STATLOCK IAB Stabilization Device
offers free securement of IAB catheters

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STATLOCK IAB Stabilization Device

Indication
For use with MAQUET Intra-Aortic
Balloon (IAB) Catheters

Contraindication
Patients with known tape or adhesive
allergy

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STATLOCK IAB Stabilization Device
Features and Benefits

FEATURES BENEFIT
• Skin-safe STATLOCK adhesive Secure IAB catheter stabilization
system
• Custom engineered locking retainer
for suture pads

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STATLOCK IAB Stabilization Device

Features and Benefits

Patient Benefit Customer benefit

Designed to provide patient comfort 100 % elimination of suture-securement
and safety needle sticks to staff

Eliminates suture-wound complication Custom designed for needle-free

(bleeding, tractions complaints, and securement of MAQUET IAB catheters
infection)

Quick and easy application and

removal

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STATLOCK IAB Stabilization Device
Package Contents

Foam Tape

Prep Pad

STATLOCK

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STATLOCK IAB Stabilization Device

Locking Retainer
(Lids)

Anchor Pad

Locking Retainer
(base)

Hydrocolloid
adhesive

Acrylic adhesive
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STATLOCK IAB Stabilization Device
Application Technique

Prep
• Prepare the targeted securement site with alcohol – Allow to dry
• Apply provided skin prep
• Allow to dry completely

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STATLOCK IAB Stabilization Device

Application Technique

Press:
• Slide STATLOCK under suture pads of IAB
• Press pads into STATLOCK retainer
• Close retainer lids to secure sheath seal
Note: Always secure catheter to STATOCK before placing pad on the skin

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STATLOCK IAB Stabilization Device
Application Technique

Place and Peel

• Place the device on targeted skin, sheath seal first and Y-fitting second
• Peel away the paper backing one side at a time and gently press adhesive
to the skin

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STATLOCK IAB Stabilization Device

Removal Technique

Disengage:
Gently lift retainer lids, one site at a time, to remove suture pad from retainer

Dissolve:
Apply alcohol to loosen edge of pad and gently lift device pad

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STATLOCK Percutaneous Sheath ®

Introducer (PSI) Stabilization Device

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STATLOCK PSI Stabilization Device

Product Overview

The STATLOCK PSI provides suture-free

securement of percutaneous sheath
introducers

Contraindication:
Patients with known tape or adhesive
allergy

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STATLOCK PSI Stabilization Device
Features and Benefits

Feature Benefit
Skin-safe STATLOCK adhesive system Secure sheath stabilization

Waxed silk ties for easy threading Utilizes the familiarity of suture tying
through sheath eyelets without associated suture-wound
complications

QLT – Sales – STATLOCK IAB and PSI ML-0580-04 Rev A

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STATLOCK PSI Stabilization Device

Patient Benefit Customer benefit

Designed to provide patient comfort 100 % elimination of suture-securement
and safety needle sticks to staff

Eliminates suture-wound complication Quick and easy application and

(bleeding, tractions complaints, and removal
infection)

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STATLOCK PSI Stabilization Device

Acrylic Adhesive

Anchor Pad

Hydrocolloid
Adhesive

Molded Retainer

Silk Ties

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STATLOCK PSI Stabilization Device

Application Technique

Prep:
• Prepare targeted skin area per hospital protocol.
• Use skin prep provided with STATLOCK PSI for enhanced pad adhesion and
skin protection.
• Allow to dry (10-15 seconds)

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STATLOCK PSI Stabilization Device
Application Technique

Application:
• Remove the middle section of the liner on back of STATLOCK PSI pad
• Place STATLOCK PSI pad to skin under sheath so that securement hole(s)
aligns with silk ties

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STATLOCK PSI Stabilization Device

Application Technique

Application (continued)
• Secure sheath and tie down
• Reaffirm proper positioning then remove wing section liners and secure to skin.

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STATLOCK PSI Stabilization Device
Removal Technique

Removal:
• Disengage sheath from retainer by carefully cutting ties
• Dissolve adhesive by gently stroking under surface of pad with alcohol swab
while continuing to lift pad
• Remove pad and discard

QLT – Sales – STATLOCK IAB and PSI ML-0580-04 Rev A

Page 349 For Internal Use Only MCV00039869 REVA

Thank You

Getinge Group is a leading global provider of equipment and systems that contribute to quality enhancement
and cost efficiency within healthcare and life sciences. We operate under the three brands of Arjohuntleigh,
Getinge and Maquet.

QLT – Sales – STATLOCK IAB and PSI ML-0580-04 Rev A

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175
Qualified Level Training
Clinical Considerations

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Indications and
Contraindications for IABC

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176
Indications

High-risk
Cath Lab CABG Surgery
Support 16%
21%

20% Cardiogenic
Weaning 15% Shock
from CABG

6% 4%
6%
12%
AMI Other
Complications Ventricular
Refractory Failure
Benchmark 2005 Angina
Page 353 For Internal Use Only QLT – Sales – Clinical Considerations ML-0580-05 Rev A

Indications for Use

1. Refractory unstable angina

2. Impending infarction
3. Acute MI
4. Refractory ventricular failure
5. Complications of acute MI
6. Cardiogenic shock
7. Support for diagnostic, percutaneous revascularization, and interventional
procedures
8. Ischemia related intractable ventricular arrhythmias
9. Septic shock

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177
Indications for Use

10. Intra-operative pulsatile flow generation

11. Weaning from bypass
12. Cardiac support for non-cardiac surgery
13. Prophylactic support in preparation for cardiac surgery
14. Post surgical myocardial dysfunction/low cardiac output syndrome
15. Myocardial contusion
16. Mechanical bridge to other assist devices
17. Cardiac support following correction of anatomical defects

Page 355 For Internal Use Only QLT – Sales – Clinical Considerations ML-0580-05 Rev A

Contraindications

1. Severe aortic valve insufficiency

2. Abdominal or thoracic aortic aneurysm
3. Severe calcific aorta-iliac disease or peripheral vascular disease
4. Sheathless insertion with severe obesity, scarring of the groin

*FDA Executive Summary, Classification of Intra-Aortic Balloon Pump Devices (December 5, 2012) page 15.

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178
Cardiogenic Shock

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Cardiogenic Shock
Acute Myocardial Infarction and Cardiogenic Shock

The most common cause of cardiogenic shock is extensive acute myocardial

infarction

Patients with previous impairment of ventricular function may also experience shock
with the occurrence of a small infarction

Reynolds H, Hochman J. Circulation 2008;117(5):686-697

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179
Cardiogenic Shock

Definition
State of end-organ hypo-perfusion due to cardiac failure

Mortality Rate
Approximately 50-80%

Incidence
5-8% of STEMIs (S-T elevation myocardial infarction)
2-5% of non STEMIs (non S-T elevation myocardial infarction)
40,000-50,000 cases per year in the US

Leading cause of death for patients hospitalized with acute MI

Reynolds H, Hochman J. Circulation 2008;117(5):686-697

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Cardiogenic Shock

Hemodynamic Parameters:
• Systolic BP < 80 to 90mmHg or a MAP 30mmHg lower than baseline
• Cardiac Index < 1.8L/m/M2 without support and adequate filling pressures
• Cardiac Index < 2.0-2.2L/m/M2 with support and adequate filling pressures
• LVEDP (Left ventricular end diastolic pressure) > 18mmHg

Recommendation regarding IABP use:

Whether shock onset occurs early or late after MI, rapid IABP placement
and angiography are recommended

Reynolds H, Hochman J; Circulation 2008;117(5):686-697

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Cardiogenic Shock

Timeframe for Development of Cardiogenic Shock

Median time frame for development of cardiogenic shock is 12 hours into AMI

39.6% develop cardiogenic shock within 6 hours

63.2% develop cardiogenic shock within 24 hours

Hasdai D, et al. American Heart Journal. 1999;138 (1 Pt 1):21-31

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Cardiogenic Shock

Cardiogenic Shock Risk Factors

• Age
• single greatest risk factor
• for every ten year increase in age, the risk
of developing shock increases by 47%

• Systolic Blood Pressure

• HR

• Killip Class

Hasdai D, et al. American Heart Journal. 1999;138 (1 Pt 1):21-31

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Cardiogenic Shock
Pathophysiology of Cardiogenic Shock

• Myocardial injury causes systolic and diastolic dysfunction

• A decrease in cardiac output leads to a decrease in systemic and coronary
perfusion
• This reduction in systemic and coronary perfusion worsens ischemia
and causes cell death in the infarct border zone and the remote zone
of myocardium
• The cardiovascular system fails to maintain sufficient perfusion resulting in
inadequate cellular metabolism and eventually cell death
• The consequence is irreversible cell damage

Reynolds H, Hochman J. Circulation 2008;117(5):686-697

Page 363 For Internal Use Only QLT – Sales – Clinical Considerations ML-0580-05 Rev A

Cardiogenic Shock
Pathophysiology of Cardiogenic Shock

Inadequate systemic perfusion triggers reflex vasoconstriction, which is usually

insufficient

SVR in cardiogenic shock is typically within a normal range, despite vasopressor

therapy

Sepsis was suspected in 18% of the SHOCK trial patients, and 74% of these
patients developed positive blood cultures

Reynolds H, Hochman J. Circulation 2008;117(5):686-697

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Cardiogenic Shock
Impact of Cardiogenic Shock

“The degree of myocardial dysfunction that initiates cardiogenic is often, but not
always, severe.”

• The challenge is that the heart benefits from low blood pressure and the resulting
afterload reduction, but at the same time suffers from decreased coronary blood
flow due to the low blood pressure

“Hemodynamics in this case may be simultaneously beneficial and detrimental.”

Reynolds H, Hochman J. Circulation 2008;117(5):686-697

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Cardiogenic Shock
Treatment

Key to Treatment

“Effective therapy for cardiogenic shock must include a prevention strategy.”

“This requires identification of patients at high risk for shock development and
selection patients who are candidates for aggressive intervention.”

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Cardiogenic Shock
Treatment

As discussed during discussion LV failure, treatment may include:

• Pharmacologic support
• Mechanical ventilation
• Counterpulsation

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IABP Shock II Study

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IABP Shock II Study

Randomized comparison of intraaortic balloon counterpulsation

versus optimal medical therapy in addition to early revascularization in
acute myocardial infarction complicated by cardiogenic shock

Holger Thiele, MD Uwe Zeymer, MD; Franz-Josef Neumann, MD; Miroslaw Ferenc,
MD; Hans-Georg Olbrich, MD; Jörg Hausleiter, MD; Gert Richardt, MD; Marcus
Hennersdorf, MD; Klaus Empen, MD; Georg Fuernau, MD; Steffen Desch, MD;
Ingo Eitel, MD; Rainer Hambrecht, MD; Jörg Fuhrmann, MD; Michael Böhm, MD;
Henning Ebelt, MD; Steffen Schneider, PhD; Gerhard Schuler, MD; Karl Werdan,
MD
University of Leipzig – Heart Center

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IABP Shock II Study

Statistical Methodology

Sample Size
• Estimated 12% absolute difference in survival rates
• 600 patients
Primary Study Endpoint
• 30-day all-cause mortality
Secondary Study Endpoints
• Hemodynamic parameters (mean BP, heart rate pre and post revascularization
• Serum-lactate
• Serial creatinine level and creatinine clearance
• Inflammatory reaction

Thiele, H, et al; N Engl J Med 2012; 367:1287-1296

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IABP Shock II Study
Trial Flow and Treatment

790 patients with AMI and cardiogenic shock screened

190 excluded because of exclusion criteria

• 60 no informed consent
• 47 resuscitation >30 minutes
• 19 shock duration >12 hours
• 18 severe peripheral artery disease
• 14 participation in another trial
• 13 no intrinsic heart activity
• 9 mechanical complications
• 3 shock of other cause
• 3 comorbidity with life expectancy <6 months
• 2 severe cerebral deficit
• 2 age >90 years

600 randomized
Thiele, H, et al; N Engl J Med 2012; 367:1287-1296

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IABP Shock II Study

Trial Flow and Treatment

600 randomized

Allocation

301 randomized to IABP 299 randomized to control

288 received IABP 269 received control therapy
13 did not receive IABP 30 cross-over to IABP (22 first day,
10 died before IABP insertion 8 day 1-8)
3 protocol violation (2 not suitable 4 mechanical complications
for revascularization, 1 serious 25 protocol violation
kinking) 1 unknown reason

Thiele, H, et al; N Engl J Med 2012; 367:1287-1296

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IABP Shock II Study
Trial Flow and Treatment

600 randomized

Revascularization
301 intended early revascularization 299 intended early revascularization
287 primary PCI 288 primary PCI
3 primary CABG 3 primary CABG
11 no revascularization 8 no revascularization
3 not suitable for revascularization 1 not suitable for revascularization
4 coronary artery disease with no 2 coronary artery disease with no
identifiable culprit lesion identifiable culprit lesion
4 no coronary artery disease 5 no coronary artery disease

Follow-Up
300 with 30-day follow-up 298 with 30-day follow up
1 lost to follow-up 1 withdrew informed consent

Primary Endpoint Analysis

300 primary endpoint analysis 298 primary endpoint analysis
Thiele, H, et al; N Engl J Med 2012; 367:1287-1296

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IABP Shock II Study

Thiele, H, et al; N Engl J Med 2012; 367:1287-1296

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187
IABP SHOCK II

IABP Control
(n = 300) (n = 298)
2/300 (0.7) 5/298 (1.7)

10/300 (3.3) 13/298 (4.4)

52/300 (17.3) 49/298 (16.4)

13/300 (4.3) 10/298 (3.4)

47/300 (15.7) 61/298 (20.5)

Thiele, H, et al; N Engl J Med 2012; 367:1287-1296

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IABP Shock II Study

Summary and Conclusions

• IABP support in cardiogenic shock is safe without significant inherent

complications.

• However, IABP support did not reduce 30-day mortality in this large,
randomized, multicenter trial in cardiogenic shock patients complicating
myocardial infarction undergoing early revascularization.

• The primary study endpoint results are supported by a lack of benefit in

secondary endpoints.

Thiele, H, et al; N Engl J Med 2012; 367:1287-1296

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IABP Shock II Study

Clinical Implications of Shock II

• In mild to moderate cardiogenic shock use catecholamine/pressors rather

than IABP?
• Be restrictive as catecholamines increase myocardial oxygen demand
• Start IABP early
• Consider severity of cardiogenic shock
• Little to no downside risk-safety of IABPs
• IABP use may allow for more complete revascularization

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IABP SHOCK II STUDY

12 Month Follow-Up

Strengths:
• Largest randomized shock trial ever performed
• 600 patients included within 32 months
• 12-month follow-up: 99.2%

Limitations:
• No hemodynamic shock assessment
• 10% crossover to IABP
• Majority of patients received IABP following PCI

Thiele, H, et al; Lancet. 2013 Nov 16;382(9905):1638-45

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189
IABP SHOCK II STUDY
Clinical outcomes at 12 months

Thiele, H, et al; Lancet. 2013 Nov 16;382(9905):1638-45

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Summary of Clinical Guidelines

Cardiogenic Shock / High-Risk PCI

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Summary of Clinical Guidelines
Cardiogenic Shock/High-Risk PCI

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IAB COUNTERPULSATION
AND HIGH-RISK PCI

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IAB Counterpulsation and High-risk PCI

High-Risk PCI - Definition

How to predict hemodynamic compromise (i.e., SBP ≤90 mm Hg) during PCI?
• LV Dysfunction (EF < 30%)
• Large area of myocardium at risk, jeopardy score>8
• Ongoing ischemia
• Multi-vessel disease
• Unprotected left main lesion
• Acute coronary syndrome

Page 383 For Internal Use Only QLT – Sales – Clinical Considerations ML-0580-05 Rev A

IAB Counterpulsation and High-Risk PCI

PCI Without Cardiogenic Shock

Clinical Study Study Type/Aim Summary

Perera et al. BCIS-1: Long Term Prospective, randomized, multi-
Mortality Data center n=300
2012 Aim: Long-term all-cause
mortality comparing elective
IABP to no planned IABP in high-
risk PCI
 IABP vs. no IABP deaths
p=0.039
 IABP during PCI
demonstrated a 34% relative
reduction in mortality

O’Neill et al. PROTECT II Prospective, randomized, multi-
center n=452
2012
Aim: Evaluate 30 day major
adverse events (MAE) comparing
Impella 2.5L to IABP
 Study stopped due to futility
 No difference in survival or
other major adverse events at
30 days

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BCIS-1 Study

Elective Intra-aortic Balloon Counterpulsation During High-risk Percutaneous

Coronary Intervention: A Randomized Controlled Trial.

Introduction

• Observational data from retrospective, non-randomized studies is all that has

been available for IABP support for the High Risk PCI patient

• No formal recommendations for elective use of IABP in current guidelines

• This study compared the efficacy and safety of elective Intra-aortic Balloon Pump
insertion prior to high-risk PCI vs. conventional treatment with no planned IABP

Perera, D, et al; JAMA 2010; 304(8):867-74

Page 385 For Internal Use Only QLT – Sales – Clinical Considerations ML-0580-05 Rev A

BCIS-1 Study

Method

Multi-centered, prospective, randomized, controlled

High Risk PCI patients defined as:
• EF ≤ 30%
• Large area of myocardium at risk: BCIS Jeopardy score ≥ 8

Perera, D, et al; JAMA 2010; 304(8):867-74

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BCIS-1 Jeopardy Score

Allows LM and Graft Classification

• 6 Major Coronary
Segments 2 2
• 2 points for each
2
lesion + 2 points for
each territory distal
to lesion 2
• Negative points for
2
functioning grafts

2
Perera D, et al AHJ 2009; in press

Page 387 For Internal Use Only QLT – Sales – Clinical Considerations ML-0580-05 Rev A

BCIS-1 Study

LVEF < 30%

Jeopardy Score ≥ 8

Randomize

Elective IABP No Planned

Insertion IABP
PCI

Remove IABP 4-24

hours after PCI
Hospital Follow-up
To discharge or 28 days

Perera, D, et al; JAMA 2010; 304(8):867-74

6 month follow-up
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BCIS-1 Study

Primary Endpoint

MACCE defined as:

• Death – all cause mortality at hospital discharge or 28 days which
ever comes first
• AMI
• Further revascularization by PCI or CABG
• Cerebrovascular event (CVA)

Perera, D, et al; JAMA 2010; 304(8):867-74

Page 389 For Internal Use Only QLT – Sales – Clinical Considerations ML-0580-05 Rev A

BCIS-1 Study

Results

• Recruitment completed January 21, 2009

• Total of 301 patients
• 151 Elective vs. 150 Conventional (no IABP)
• Patient demographics were similar in both groups

Perera, D, et al; JAMA 2010; 304(8):867-74

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BCIS-1 Study - Major Outcomes
Summary

25 HR 1.86
(0.93-3.79)

20 HR 0.94
(0.51-1.76)
Adverse Events (%)

15 HR 0.11
(0.01- 0.49) HR 0.61
(0.24-1.62)
10

0
In-Hospital MACCE Procedural Major or Minor 6-Month Mortality
Complications Bleeding
Elective IABP No Planned IABP

Perera, D, et al; JAMA 2010; 304(8):867-74

Page 391 For Internal Use Only QLT – Sales – Clinical Considerations ML-0580-05 Rev A

BCIS-1 Study

MACCE to Hospital Discharge

IABP No Planned IABP

n=151 (%) N=150 (%) p value*

Death 3 (2.0) 1 (0.7) 0.40

CVA 2 (1.3) 0 (0.0)

MI 19 (11.3) 20 (13.3) 0.43

Revasc 1 (0.0) 4 (1.4) 0.13

Total 23 14.6 24 15.3 0.35

* Cox regression
Perera, D, et al; JAMA 2010; 304(8):867-74 1 patient had MI and died; 2 patients had MI and PCI
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BCIS-1 Study

Major Secondary Outcomes

IABP No Planned IABP p value

6 month mortality 7 (4.6%) 11 (7.3%) 0.32†

Procedural complication 2 (1.3) 16 (10.7) 0.001

Access site complication 5 (3.3) 0 (0) 0.06*

All bleeds 29 (19.3) 17 (11.3) 0.058

Major bleeds 5 (3.3) 6 (4.0) 0.77
Minor bleeds 24 (15.9) 11 (7.3) 0.021
Procedural success 230 (93.5) 237 (93.3) 0.93

Length of stay - mean 2 (1,5) 2 (1,4) 0.12

days (SD)
† 2 test

Perera, D, et al; JAMA 2010; 304(8):867-74

* Fisher’s exact test
Page 393 For Internal Use Only QLT – Sales – Clinical Considerations ML-0580-05 Rev A

BCIS-1 Study
6 Month Mortality

7.3%

4.6%

P = 0.32

Perera, D, et al; JAMA 2010; 304(8):867-74

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BCIS-1 Study

Discussion

• BCIS-1 is the first randomized trial of elective vs. “bailout” IABP in patients with poor LV
function and severe coronary disease

• 12% in the conventional group required emergency IABP during the procedure, supporting
the important role of provisional IABP for High Risk patients prior to PCI

• Although there was not evidence of statistical significance to reduce MACCE at hospital
discharge, mortality curves beyond 30 days do increasingly favor elective IABP and the
Investigators are planning to do a twelve month follow up

• Patients with poor LV function and severe coronary disease treated by PCI appear to have
low in-hospital and 6 month mortality

Perera, D, et al; JAMA 2010; 304(8):867-74

Page 395 For Internal Use Only QLT – Sales – Clinical Considerations ML-0580-05 Rev A

BCIS-1 Long-Term Follow-up Study

Ethics/IRB approval granted for extended follow-up

Primary Endpoint:
All-cause Mortality
Follow-up status:
Mortality data collection completed for 301 patients (100%) in October 2011
(randomisation period Dec 2005 – Jan 2009)

Perera, D, et al; Circulation 2013; 127: 207-212

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BCIS-1 Long-Term Follow-up
Results

Duration of follow-up (from randomisation): Median 51 months (IQR 41-58

months)
100 DEATHS (33%)

IABP No IABP
n = 151 n = 150
Deaths 42 58

Person-years of follow-up 532 480

Rate (per 100 person-years 7.89 12.08

Hazard ration (95% confidence interval) 0.66 (0.44 to 0.98)

P-value 0.039

Perera, D, et al; Circulation 2013; 127: 207-212

Page 397 For Internal Use Only QLT – Sales – Clinical Considerations ML-0580-05 Rev A

BCIS-1 Long Term Follow-up

Results
All-cause Mortality by Treatment Assignment

50%
IABP
No IABP

40%
Cumulative percentage

30%

20%
Hazard ratio 0.66 (95% CI 0.44 to 0.98)
10%

0%
0 6 m 1 year 2 years 3 years 4 years 5 years
Time since randomisation

IABP 151 144 137 127 111 66 21

No IABP 150 139 130 117 93 52 19

Perera, D, et al; Circulation 2013; 127: 207-212

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BCIS-1 Long-Term Follow-up
Conclusions

• In patients with severe ischemic cardiomyopathy treated with PCI, all cause-
mortality was 33% at 51 months (median)
• Elective IABP use during PCI was associated with an observed 34% reduction in
long-term all-cause mortality
• The mode of death and the putative mechanism of benefit of counterpulsation
are unclear at present

Perera, D, et al; Circulation 2013; 127: 207-212

Page 399 For Internal Use Only QLT – Sales – Clinical Considerations ML-0580-05 Rev A

Summary of Clinical Guidelines

Cardiogenic Shock / High-Risk PCI

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200
Summary of Clinical Guidelines
Cardiogenic Shock/High-Risk PCI

Page 401 For Internal Use Only QLT – Sales – Clinical Considerations ML-0580-05 Rev A

Potential Side Effects and

Complications

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201
Potential Side Effects and Complications
Limb Ischemia

Assessment:
• Check distal pulses, color, temperature, and capillary refill every 30 minutes x 2
hours, then every 2 hours
• Monitor differential toe temperatures

Prevention:
• Use smallest sheath/catheter size available
• Evaluate for risk factors: female, diabetic, PVD
• Select the limb with the best pulse

Intervention:
• Subcutaneous Xylocaine injection for arterial spasm
• Change insertion site to opposite limb
• Bypass graft the femoral artery insertion site

Page 403 For Internal Use Only QLT – Sales – Clinical Considerations ML-0580-05 Rev A

Potential Side Effects and Complications

Excessive Bleeding from Insertion Site

Assessment:
• Observe anteriorly and posteriorly for bleeding or hematoma formation

Prevention:
• Employ careful insertion technique
• Monitor anticoagulation therapy
• Prevent catheter movement at insertion site

Intervention:
• Apply direct pressure at insertion site, assuring distal blood flow
• Surgical repair of the insertion site

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Potential Side Effects and Complication
Thrombocytopenia

Assessment:
• Assess platelet count daily

Prevention:
• Avoid excessive heparin administration

Intervention:
• Replace platelets as needed

Page 405 For Internal Use Only QLT – Sales – Clinical Considerations ML-0580-05 Rev A

Potential Side Effects and Complication

Immobility of the Balloon Catheter

Assessment:
• Observe movement of IAB status indicator
• Evaluate arterial waveform for diastolic augmentation

Prevention:
• Do not allow IAB to be immobile in patient for > 30 min.
• Maintain an adequate trigger

Intervention:
• Notify the physician if IAB is immobile for > 30 min.
• If unable to inflate IAB with the IABP, inflate and deflate IAB by hand, using a
syringe and stopcock once every 5 min. with 40cc of air or Helium

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Potential Side Effects and Complication
Balloon Leak

Assessment:
• Observe helium tubing for blood with or without the presence of a blood
detected, low augmentation, gas loss, and/or IAB catheter alarm

Prevention:
• Do not remove IAB from T-handle/tray until ready to insert

Intervention:
• If blood is observed in catheter extender tubing, disconnect IAB from pump and
notify physician immediately

Page 407 For Internal Use Only QLT – Sales – Clinical Considerations ML-0580-05 Rev A

Potential Side Effects and Complication

Balloon Leak

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204
Potential Side Effects and Complication
Balloon Leak

Page 409 For Internal Use Only QLT – Sales – Clinical Considerations ML-0580-05 Rev A

Potential Side Effects and Complication

Infection

Assessment:
• Observe insertion site for signs of infection
• Culture blood if symptoms of infection present

Prevention:
• Use sterile technique during insertion of the IAB catheter
• Change dressings using sterile technique per infection control policy

Intervention:
• Antibiotics

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Potential Side Effects and Complication
Aortic Dissection

Assessment:
• Assess patient for pain between shoulder blades
• Monitor hematocrit daily
• If dissection is suspected, an aortogram may be indicated

Prevention:
• Insertion of the IAB over a guidewire with fluoroscopic control

Intervention:
• Balloon removal
• Surgical repair of the dissection

Page 411 For Internal Use Only QLT – Sales – Clinical Considerations ML-0580-05 Rev A

Potential Side Effects and Complication

Compartment Syndrome

Assessment:
• Observe limb for swelling and/or hardness
• Measure and record calf girth
• Monitor interstitial pressure

Prevention:
• Use smallest catheter/sheath available
• Maintain adequate colloid osmotic pressure

Intervention:
• Fasciotomy if necessary

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206
Thank you!

Getinge Group is a leading global provider of equipment and systems that contribute to quality enhancement
and cost efficiency within healthcare and life sciences. We operate under the three brands of Arjohuntleigh,
Getinge and Maquet.

Page 413 For Internal Use Only QLT – Sales – Clinical Considerations ML-0580-05 Rev A

Qualified Level Training

Competitive Products

Page 414 For Internal Use Only QLT

QLT–– Sales
Sales –– Competitive
Competitive Products
Products ML-0580-06
ML-0580-06 Rev
Rev AA

207
Arrow International / Teleflex Medical

Overview

• Largest IABP Competitors

• Low price sales strategy
• Limited R&D investment – past 10 years

Page 415 For Internal Use Only QLT– Sales – Competitive Products ML-0580-06 Rev A

Arrow International / Teleflex Medical

IABP Products
• AutoCAT2 WAVE
• AutoCAT2
• Aero Series - AutoCAT2 WAVE for Transport
• Aero Series - AutoCAT2 for Transport
• Languages (unconfirmed)
• English, German, Spanish
French, Italian, Dutch, Japanese, Swedish

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208
Arrow International / Teleflex Medical

IAB Products
• FiberOptix 8Fr.
• UltraFlex
• Ultra 8
• NarrowFlex
• RediGuard

Page 417 For Internal Use Only QLT– Sales – Competitive Products ML-0580-06 Rev A

Arrow Pump Consoles

AutoCAT2 Wave

• First shown – STS Meeting Jan. 2003

• Auto Pilot and Operator operation modes.
• Auto Pilot automatically adjusts timing and
triggering to optimize counterpulsation support
• Arrow/Teleflex promotes system as providing
“ProActive CounterPulsation”
• Capable of fiber-optic pressure monitoring with
Arrow FiberOptix catheter
• WAVE algorithm only works with the Arrow/Teleflex
fiber-optic balloon catheter
• Bellows pneumatic platform
• Competes with the CS100 and CS300
• Available as a console or air transport version
• Available in multiple languages

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209
AutoCAT2 WAVE

• Triggers
• Peak, Pattern, A-fib, AP (Arterial Pressure),
APace, VPace, Internal
• Frequency
• 1:1, 1:2, 1:4, 1:8
• Operating Modes
• Auto Pilot and Operator Mode
• Battery Life - 1.5 Hour

Page 419 For Internal Use Only QLT– Sales – Competitive Products ML-0580-06 Rev A

Bellows Drive System Components

Arm rotates
Bellows moves axially

IAB

Lead - screw
rotates

A bellows design has inherent speed limitations.

To effect inflation or deflation, the bellows, lead screw and motor must do the
following: Accelerate from a stop and then decelerate to a stop.
This results in time delays. During arrhythmias, the delays in inflation and deflation
can effect peak augmentation and unloading.
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210
Pneumatic Speed Comparisions

Maquet CARDIOSAVE® and CS300 ™ vs. Arrow AutoCAT2 WAVE®

Combined Inflate/Deflate Speed (milliseconds)

Data based on bench-top testing and on file at Maquet.

All measurements completed using a MEGA 8 Fr. 50cc IAB under the same physical conditions.
Page 421 For Internal Use Only QLT– Sales – Competitive Products ML-0580-06 Rev A

Pneumatic Speed Comparisions

Maquet CARDIOSAVE and CS300 vs. Arrow AutoCAT2 WAVE

Combined Inflate/Deflate Speed (milliseconds)

Data based on bench-top testing and on file at Maquet.

All measurements completed using a MEGA 8 Fr. 50cc IAB under the same physical conditions.
Page 422 For Internal Use Only QLT– Sales – Competitive Products ML-0580-06 Rev A

211
Pneumatic Speed Comparisions

Maquet CARDIOSAVE and CS300 vs. Arrow AutoCAT2 WAVE

Combined Inflate/Deflate Speed (milliseconds)

Data based on bench-top testing and on file at Maquet.

All measurements completed using a MEGA 8 Fr. 50cc IAB under the same physical conditions.
Page 423 For Internal Use Only QLT– Sales – Competitive Products ML-0580-06 Rev A

Pneumatic Speed Comparisions

Maquet CARDIOSAVE and CS300 vs. Arrow AutoCAT2 WAVE

Combined Inflate/Deflate Speed (milliseconds)

Data based on bench-top testing and on file at Maquet.

All measurements completed using a MEGA 8 Fr. 50cc IAB under the same physical conditions.
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Pneumatic Speed Comparisions

Maquet CARDIOSAVE and CS300 vs. Arrow AutoCAT2 WAVE

Combined Inflate/Deflate Speed (milliseconds)

Data based on bench-top testing and on file at Maquet.

All measurements completed using a MEGA 8 Fr. 50cc IAB under the same physical conditions.
Page 425 For Internal Use Only QLT– Sales – Competitive Products ML-0580-06 Rev A

Pneumatic Speed Comparisions

Maquet CARDIOSAVE and CS300 vs. Arrow AutoCAT2 WAVE

Combined Inflate/Deflate Speed (milliseconds)

Data based on bench-top testing and on file at Maquet.

All measurements completed using a MEGA 8 Fr. 50cc IAB under the same physical conditions.
Page 426 For Internal Use Only QLT– Sales – Competitive Products ML-0580-06 Rev A

213
Arrow AutoCAT2 WAVE IABP
Proactive Counterpulsation

Proactively anticipate aortic valve closure before it occurs even during severe
arrhythmias

Calculates aortic flow based on the arterial pressure signal from the FiberOptix
catheter for each beat

Page 427 For Internal Use Only QLT– Sales – Competitive Products ML-0580-06 Rev A

WAVE - Windkessel Aortic Valve Equation

• The WAVE algorithm makes fixed assumptions

• Assumes every patient will have a dicrotic notch at
the same point during the cardiac cycle
• The WAVE algorithm predicts where the dicrotic notch
will occur
• This is a fixed assumption, not formulated specifically
for each patient
• WAVE algorithm only controls inflation timing, not
deflation
• WAVE algorithm only used with fiber optic pressure
signal

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214
AutoCAT2 WAVE Set-up

• Power on the pump

• Establish ECG
• Connect Blue Sensor and Cal. Key to console prior to
insertion – Sensor must be calibrated before
catheter insertion.
• When the pump reaches a stable temperature, zeroing
will start automatically
• Catheter can now be inserted into patient
• Connect IAB catheter to pump
• Press pump ON

Page 429 For Internal Use Only QLT– Sales – Competitive Products ML-0580-06 Rev A

AutoCAT2 WAVE
Advantages

• Often less expensive

• Lighter weight than CS300/CS100

• Customers like the WAVE algorithm

• Customers loyal to Arrow brand

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215
AutoCAT2 WAVE
Disadvantages

• Longer set up time

• Fiber optic sensor must be calibrated prior to insertion –
outside the patient
• Cannot automatically calibrate inside the patient
• Timing algorithm doesn’t learn each patient - makes
fixed assumptions
• WAVE algorithm only works with inflation
• WAVE algorithm only works when using a fiber optic
catheter
• In Autopilot Mode, user is unable to fine-tune deflation
timing
• Pneumatic system is slower

Page 431 For Internal Use Only QLT– Sales – Competitive Products ML-0580-06 Rev A

Arrow IABPs
AeroCAT Series

• AeroCAT2 – No fiberoptics
• AeroCAT2 WAVE
• Specifically designed for transport
• 90 pounds / 41 kg.

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Arrow IAB Catheters

ARROW CATHETERS

REDIGUARD

NARROWFLEX

ULTRAFLEX

ULTRA 8

FIBEROPTIX 8

Page 433 For Internal Use Only QLT– Sales – Competitive Products ML-0580-06 Rev A

Arrow IAB Catheters

• All Arrow catheters have the same balloon

membrane - Cardiothane II
• Only the Ultra 8 and FiberOptix 8 do not have a
stepdown between the wrapped balloon and the
catheter shaft
• Arrow insertion kits have 2 sheaths and 2 guide
wires
• Arrow catheters have a co-axial design

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Arrow IAB Catheters
RediGuard IAB Catheter

• Oldest and Least Expensive Arrow Catheter

• Polyurethane catheter
• Wire reinforced inner lumen
• Balloon Size / Catheter Diameter / Sheath Diameter
• 30cc 7 Fr. Catheter / 8 Fr. Sheath
• 40cc 8 Fr. Catheter / 9 Fr. Sheath
• 50cc 9 Fr. Catheter / 10 Fr. Sheath
• Large Stepdown
• Central Lumen & Guidewire Size
• 0.027”/ 0.025”

Page 435 For Internal Use Only QLT– Sales – Competitive Products ML-0580-06 Rev A

Arrow IAB Catheters

FiberOptix 8 IAB Catheter

• Polyurethane catheter
• Stainless steel inner lumen
• Fiberoptic sensor
• No Step-down
• Balloon Sizes
• 30cc
• 40cc
• Catheter and Sheath Diameter
• 8 Fr. Catheter / 8Fr. Sheath
• Central Lumen and Guidewire Size
• 0.027” / 0.025”

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Arrow IAB Catheters
UltraFlex 7.5Fr IAB Catheter

• Wire reinforced polyurethane catheter

• Stainless steel inner lumen
• Balloon Sizes
• 30cc
• 40cc
• Catheter and Sheath Diameter
• 7.5Fr. Catheter / 8Fr. Sheath
• Inner Lumen and Guidewire Size
• 0.027” / 0.025”

Page 437 For Internal Use Only QLT– Sales – Competitive Products ML-0580-06 Rev A

Arrow IAB Catheters

Ultra 8 IAB Catheter

• Polyurethane catheter
• Stainless steel inner lumen
• No Stepdown
• Balloon Sizes
• 30cc
• 40cc
• Catheter and Sheath Diameter
• 8Fr. Catheter / 8Fr. Sheath
• Inner Lumen and Guidewire Size
• 0.027” / 0.025”

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Arrow IAB Catheters
NarrowFlex IAB Catheter

• Wire reinforced catheter

• Nitinol inner lumen
• Balloon Sizes
• 30cc
• 40cc
• Catheter and Sheath Diameter
• 8Fr. Catheter / 9Fr. Sheath
• Inner Lumen and Guidewire Size
• 0.032” / 0.030”

Page 439 For Internal Use Only QLT– Sales – Competitive Products ML-0580-06 Rev A

Arrow IAB Catheters

Advantages

• Usually less expensive

• Some customers like their stronger, stiffer catheters
• Sheath has a sideport
• Insertion kit includes 2 sheaths and 2 guidewires
• FiberOptix catheter has large inner lumen that provides additional pressure
monitoring capability (compared to Sensation)
• FiberOptix inner lumen same size as Sensation Plus

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220
Arrow IAB Catheters
Disadvantages

• Most catheters have a “stepdown”

• Most sheaths are bigger than catheter
• More insertion force required to insert the catheter
• Stiffer catheter shaft
• Cardiothane II membrane 43 % less abrasion resistant than MAQUET
membrane
• No 25cc IAB
• FiberOptix catheters require calibration before insertion (outside the body)
• Unable to calibrate in vivo
• FiberOptix cable more likely to tangle

Page 441 For Internal Use Only QLT– Sales – Competitive Products ML-0580-06 Rev A

Arrow Pump Adapter - APA

Maquet IAB to Arrow AutoCAT2 WAVE

Order Maquet IAB catheter with APA

Part Number end with - 02
• Maquet 25cc, 30cc, 34cc, and 40cc
IABs can be ordered with a Blue 40cc
APA
• Maquet 50cc IAB can be ordered with
an Orange 50cc APA

Refer to the instructions for use for

detailed instructions

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Adapting a Maquet Balloon to an Arrow Pump

When an Arrow IAB pump is used:

• Connect the IAB catheter’s male luer fitting to the female luer fitting of the
provided catheter extender.
• Connect the male luer fitting of the provided catheter extender to the female luer
fitting of the Arrow pump Adapter.
• Connect the Arrow pump Adapter to the appropriate system.
• Adjust the volume setting on the Arrow pump, according to the operating
instructions, to match the IAB catheter volume.

Page 443 For Internal Use Only QLT– Sales – Competitive Products ML-0580-06 Rev A

Arrow Volume Control

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222
Thank You

Getinge Group is a leading global provider of equipment and systems that contribute to quality enhancement
and cost efficiency within healthcare and life sciences. We operate under the three brands of Arjohuntleigh,
Getinge and Maquet.

Page 445 For Internal Use Only QLT– Sales – Competitive Products ML-0580-06 Rev A

Qualified Level Training

CA Complaint Handling

For Internal Use Only QLT - Sales – Complaint Handling ML-0620 Rev A

223
Complaint Handling

Why is it Important
• Product complaints must be reported to regulatory authorities
• Need to address customers’ concerns
• Provide information on product performance
• Provide feedback for future product enhancements

For Internal Use Only QLT - Sales – Complaint Handling ML-0620 Rev A

Complaint Handling
Responsibilities

Maquet Associate is responsible for:

• Informing a member of quality of any written, electronic, or oral communication
that alleges a deficiency related to the identity, quality, durability, reliability,
safety, effectiveness, or performance of any Maquet product after it has been
released for distribution.
• Reporting the complaint to the Designated Complaint Unit (DCU) per global
requirements.

For Internal Use Only QLT - Sales – Complaint Handling ML-0620 Rev A

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Complaint Handling
Definition of a Complaint

A product complaint is defined as any written, electronic, or oral communication that

alleges deficiencies related to the identity, quality, labeling, durability, reliability,
safety, effectiveness, or performance of a medical device after it has been released
for distribution.

For Internal Use Only QLT - Sales – Complaint Handling ML-0620 Rev A

Complaint Handling
Definition of a Complaint

Examples of “complaints” include but are not limited to the following:

• Communication alleges patient death, injury, adverse event, reaction of any kind,
side effects, pain, need for medical intervention to any person (user, patient,
customer, healthcare provider)

• Failure to operate as intended, failure to meet intended use

• Repair or service requests when device fails to perform their intended function

• Report of a device/part that indicates smoking, burning, smoldering, sparking, on

fire, electrical/burning smell, hot to touch

• Concern of possible tampering, potential counterfeit/forgery of a device or part

• Concern regarding closure, container, seal, or packaging integrity

For Internal Use Only QLT - Sales – Complaint Handling ML-0620 Rev A

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Complaint Handling
Definition of a Complaint

Examples of “complaints” (continued):

• Any report of dissatisfaction with the product or its labeling

• Difficulty reading or interpreting labeling, illegible labeling, missing labels

• Missing labels, labeling, parts, pieces, or components

• Discrepancies in lot numbers on packaging, missing labeling information, missing

lot number or expiration date

• Product shipped from Maquet after expiration

• Indications of use/user errors, misuse, off-label use

Note: Use / User errors are not the same as user-induced accidental damage
(e.g. user admits bumping the device into the wall and breaking it)

• Parts not fitting, disengaging, not staying in place

For Internal Use Only QLT - Sales – Complaint Handling ML-0620 Rev A

Complaint Handling
Definition of a Complaint

Examples of event that do not fall under this procedure:

• The device/part was not a Maquet device/part

• Request for preventive maintenance or calibration as defined with the labeling
(e.g. IFU, service manual)
• Returns/repairs initiated by Maquet as part of a Field Action
• Request of a replacement order that is not replacing a malfunctioning product
• Request for credit, billing errors or disputes, scheduling, or delivery concerns (e.g.
shipping damage, late arrival)
• Requests for product information, literature, or promotional materials, general
question about product use, instructions for use
• Expressions of customer preference where there is no specific statement of
dissatisfaction
• Customer training

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Complaint Handling
Source of Complaints

Complaints may originate from any source, including but not limited to consumers,
MAQUET employees, user facilities, distributors, original equipment manufacturer
(OEM) customers, service requests, regulatory agencies, publications

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Complaint Handling
Reporting Complaints

• Every Maquet associate is responsible for immediately (within 24 hours) informing

a member of Quality or the Designated Complaint Unit (DCU) of any written,
electronic, or oral communication that alleges a deficiency related to the identity,
quality, durability, reliability, safety, effectiveness, or performance of any Maquet
product after it has been released for distribution.

• Provide the contact information of the person making the complaint

• Additional information to obtain
- description of the alleged incident or deficiency
- date the allegation was made to Maquet
- any actions that were mentioned as having been taken as a result of the alleged
incident or deficiency

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Complaint Handling
Reporting Complaints

• For Cardiac Assist products, the DCU is pssd@getinge.com

• Potentially serious public health threats should be reported to Senior Management

within 24 hours

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Complaint Handling
Field Complaint Intake Form

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Complaint Handling
Product Returns

Hardware:
• Products / parts may need to be returned to complete the complaint evaluation in
some cases such as:
- Death or serious injury
- Field corrective actions when indicated
- When determined by Quality System Performance Data Analysis
- As requested by management

• SSU is responsible for coordinating the return of the part / device when return is
indicated

For Internal Use Only QLT - Sales – Complaint Handling ML-0620 Rev A

Complaint Handling
Product Returns

Disposables:

• US: A Biohazard Return Kit with instructions for handling, packaging, and shipping
the device / part is sent to the customer or SSU representative as agreed upon to
accommodate the return of the complaint device / part.

• Outside the US: The return package is coordinated by MAQUET International

Sales / Clinical Representatives or Distributors, who will send the return package
to the customer.

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Complaint Handling
Product Returns

Disposables:

• STATLOCK Products: The DCU Representative prepares the return package that
will be forwarded to the facility and will include the following:

- If required, the STATLOCK Field Intake Form with the complaint number
- Shipping box, including packing materials and instructions
- Return shipping label
- The DCU Representative forwards all complaints to
FA.Complaints.SLC@crbard.com for evaluation

For Internal Use Only QLT - Sales – Complaint Handling ML-0620 Rev A

Thank you!

www.getingegroup.com

Getinge Group is a leading global provider of innovative solutions for operating rooms,
intensive-care units, hospital wards, sterilization departments, elderly care and for life
science companies and institutions. With a genuine passion for life we build quality and
safety into every system. Our unique value proposition mirrors the continuum of care,
enhancing efficiency throughout the clinical pathway. Based on our first-hand
experience and close partnerships, we are able to exceed expectations from
customers – improving the every-day life for people, today and tomorrow.

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 Higher Efficacy for
Your Patient
Larger Volume IAB in Real-World
Practice

Mega IAB Family

Sizing

Higher Efficacy IAB

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 40cc vs. 50cc IAB

Blood volume displacement

Offers 25% more blood volume displacement

than 40cc*
Delivers 10cc more volume at a comparable
speed than 40cc*
* Bench testing completed by MAQUET. Data on file. Bench test results are not necessarily predictive of clinical results.

Higher Efficacy IAB

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Greater Hemodynamic Support

Larger volume IAB

What are the benefits?

 More blood volume displacement*
 More diastolic augmentation*
 More systolic unloading*

What does it mean for your patient?

 Greater hemodynamic support

* Bench testing completed by MAQUET. Data on file. Bench test results are not necessarily predictive of clinical results.

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Tertiary Care Experience Utilizing the Mega 50cc IAB ®

Visveswaran et al.

Intra-aortic balloon counterpulsation using a 50cc volume balloon

appears effective as a first line percutaneous circulatory support
strategy in a large fraction of critically ill cardiac patients
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Tertiary Care Experience Utilizing the Mega 50cc IAB

Introduction
 The newer volume Mega 50cc IAB offers improved
diastolic augmentation and better left ventricular(LV)
unloading compared to the 40cc IAB
Methods
 Retrospective, single center review of all patients who
received a MEGA 50cc IAB from 2011-2015
 Total cohort: N=150
− Cardiogenic shock (CS) subgroup N=100
− Non-cardiogenic shock (non-CS) subgroup N=50
 Primary Outcomes
− Serial renal function
− Survival to hospital discharge
 Adverse events
− Bleeding requiring transfusions; surgical bleeding;
minor and major vascular complications
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Tertiary Care Experience Utilizing the Mega 50cc IAB

Results

Higher Efficacy IAB

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Tertiary Care Experience Utilizing the Mega 50cc IAB

Results

Higher Efficacy IAB

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Tertiary Care Experience Utilizing the Mega 50cc IAB

Discussion

 This contemporary cohort of IABC patients had worse cardiac function than those
reported in the Benchmark Registry or in IABPSHOCK II (LVEF 20.2%)
 Positive hemodynamics:
▪ +42 mmHg in diastolic augmentation
▪ -15 mmHg systolic unloading
▪ -7 mmHg diastolic unloading
▪ +1.03 l/min cardiac output
▪ +.046 ml/min m² cardiac power output
 Overall complications rate was 2.7% validating the known safety and easy deployment
capabilities of IABC therapy
 There is significant cost associated with newer mechanical circulatory support
devices*

*Shah et al. J INVASIVE CARDIOL

2015;27(3):148-154

Higher Efficacy IAB

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Hemodynamic Effects of 40cc vs. Mega 50cc IAB

Kapur et al.

In real-world practice the Mega 50cc IAB provides greater diastolic

augmentation and systolic unloading compared to the 40cc IAB

Higher Efficacy IAB

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Hemodynamic Effects of 40cc vs. Mega 50cc IAB

Introduction
 The aim of this study was to explore the
hemodynamic effects of the Mega 50cc IAB in
real-world practice
Methods
Retrospective, single center review of 52 patients
− N=26 patients with the 40cc IAB
− N=26 patients with the Mega 50cc IAB
Data Obtained:
− Patient demographics
− Indication for use
− Clinical outcomes: in-hospital mortality and
device related complications
− Hemodynamic measurements

Higher Efficacy IAB

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Hemodynamic Effects of 40cc vs. Mega 50cc IAB

Methods for IABP tracing analysis

Systolic Unloading
 Difference between unassisted systole (B) and assisted systole (F) pressure
Diastolic Augmentation
 Difference between non-augmented (A) and augmented diastolic (D) pressure

Higher Efficacy IAB

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Hemodynamic Effects of 40cc vs. Mega 50cc IAB

Results: Demographics and indications

No difference in patient baseline characteristics or medications used

were observed

Indications for Use:

Acute decompensated heart failure (ADHF); Acute coronary syndrome (ACS); ST elevated myocardial infarction
(STEMI);Cardiogenic shock (CGS;) High-risk percutaneous coronary intervention (HR-PCI)

Higher Efficacy IAB

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Hemodynamic Effects of 40cc vs. Mega 50cc IAB

Results: Hemodynamic variables

Note: PA catheter data available before and after IAB implantation in 20 patients
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Hemodynamic Effects of 40cc vs. Mega 50cc IAB

Results: Hemodynamic variables

Within 24 hours of the Mega 50cc IAB activation:

• PA diastolic and occlusion pressures were reduced
• CO, CI and PA oxygen saturation pressures increased
• Absolute change in CO:
• 0.7L (18%)in the 40cc group and 1.4L (40%) in the Mega
50cc group (P=.08)

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Hemodynamic Effects of 40cc vs. Mega 50cc IAB

Discussion

 Mega 50cc IAB provides greater diastolic augmentation and systolic unloading
compared to the 40cc IAB
 Mega 50cc IAB compared with the 40cc IAB recipients:
 Achieved a greater reduction in cardiac filling pressures and increase in cardiac
output
 A reduction in systolic pressure >10 mmHg
 The magnitude of systolic unloading correlates directly with the magnitude of
diastolic augmentation and inversely with PA occlusion pressures

Higher Efficacy IAB

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239
Impella CP vs. IABP in AMI Complicated by
Cardiogenic Shock: IMPRESS Trial

ML-0632 Rev A

IMPRESS Trial
Introduction
• The goal of the trial was to compare outcomes following Impella CP or IABP in
patients presenting with STEMI and CS and undergoing primary PCI

Methods
• Multicenter, open-label, randomized study
• Primary endpoint: 30-day all-cause mortality
• Secondary endpoint: 6 month mortality
• Total of 48 patients: Impella CP (n=24); IABP (n=24)

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IMPRESS Trial
Results
• Baseline patient characteristics similar in both groups
• Notable characteristics:
- Infarct-related artery: LAD: 65%
- Multi-vessel disease: 76%
- Cardiac arrest before randomization: 92%
- Baseline ejection fraction:
◦ <20% Impella 23% vs IABP 44%
◦ 20-40% Impella 46% vs IABP 33%
◦ >40% Impella 32% vs IABP 22%
- Median duration of support 48 hours

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IMPRESS Trial
Results
• 30 day mortality
- Impella CP 46% vs. IABP 50%
p=0.92
• 6 month mortality
- Impella CP 50% vs. IABP 50%,
p=0.92
• LVEF after 2.5 months:
- Impella CP 46% vs. IABP 49%

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IMPRESS Trial
Complications
Complications Impella CP IABP
Major vascular complication 4% 0%
Major Bleeding 33% 8%
Hemolysis requiring extraction of 8% 0%
the device

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IMPRESS Trial
Discussion
• Impella CP was not associated with lower 30-day or 6 month mortality when
compared to IABP
• Vascular and bleeding complications were higher with Impella CP
• Any kind of MCS may be of limited clinical utility in patients who had resuscitated
cardiac arrest
• In both Impella CP and IABP there was trend towards lower mortality when the
devices were initiated before the PPCI
• The trial was underpowered

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Impella vs. IABP in CS
Meta-analysis of Randomized Controlled Trials
• All trials were underpowered
• Total of 95 patients Impella (n-49)
IABP (n=46)
• No difference in all-cause mortality at
30-days and 6 months
• No difference in LVEF
• Majority of patients treated after
revascularization

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IMPRESS Trial
Questions remain
• Is any MCS able to reduce CS mortality?
• Do we have appropriate patient selection?
• Is the lack of efficacy of MCS based on inappropriate timing of device insertion in
the course of CS and also in relation to primary PCI?
• Should devices with low complication rates be chosen more liberally in the early
stages of CS?

Zeymer U, Thiele H,, J Am Coll Cardiol (2016); doi:10.1016

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