RotablatorTM

Rotational Atherectomy System

In-Service Presentation

These materials are not for use in the US or Japan

RotablatorTM
Rotational Atherectomy System

Agenda

• What is the Rotablator System?

• Clinical Application
• Mechanism of Action
• Cautions, Indications, Contraindications
• Rotational Atherectomy Overview
• Hardware Components Overview
• Disposable Components Overview
• Procedural Information
• Management of Complications
• Frequently Asked Questions

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RotablatorTM
Rotational Atherectomy System

What is the Rotablator System?

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RotablatorTM
Rotational Atherectomy System

What is the Rotablator System?

• Rotational Atherectomy System
– Diamond-tipped burr designed to preferentially ablate calcium
and fibrous plaque
• System includes both capital equipment
and disposable components
– Capital Equipment
• Console
• Foot Pedal
• Air Tank
– Disposables
• Wires
• Advancer
• Burr

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RotablatorTM
Rotational Atherectomy System

Clinical Application

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 Clinical Application

Why use Rotational Atherectomy?

Calcium is out there.

The prevalence of severe calcium, defined as superficial in nature with greater than 180°
arc, is estimated to present itself in 12% of cases using angiographic imaging. When IVUS
guidance is used, it’s seen in approximately 26% of cases. 1

Calcium can preclude optimal stenting.

Asymmetrical stent expansion occurs in up to 50% of cases where calcium is not treated
before stent deployment.2

With DES, rotational atherectomy is an important tool for calcified lesions.

Lesion preparation with compliance change for a calcified lesion can substantially facilitate
stent delivery and symmetrical stent expansion for more homogeneous drug delivery. 3

1. Mintz et al. Patterns of Calcification in Coronary Artery Disease. Circulation April 1995, Volume 91, No 7
2. Moussa, Moses, Columbo et al. Coronary Stenting After Rotational Atherectomy in Calcified and Complex Lesions. Circulation 1997; 96:128-136
3. Iakovou, I. et. al. J Am Coll Cardiol 2005;46:1446-55
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Clinical Application

SPORT1 (Stent Implantation Post Rotational Atherectomy Trial)

While moderate de-bulking did not significantly improve clinical outcomes (TVR and TLR),
it did result in higher acute procedural success and larger final lumen diameters.
The study limitations included a lesion subset of mostly lesions with minimal calcification
where de-bulking with RA is known to be of limited value.

ROTA + Stent PTCA + Stent P-value

(n=360) (n=375)
Post Procedure 2.81  0.44 2.74  0.40 p= 0.032
MLD
Acute Gain 1.94  0.50 1.86  0.48 p= 0.041
Technical Success 93.1% 87.7% p=.0146
Procedure Success 93.6% 88.1% p=.0114
Clinical Success 91.6% 87.0% p=.0495

1 Buchbinder, M., et al, presentations at TCT 2001 & ACT 2001

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 Clinical Application

• Single 2.75 mm stent placed

• Post Dilatation: 3.5x9 mm non-

compliant balloon for 30 seconds
at 22 ATM (2229 kPa) followed by
4.0x9 mm non- compliant balloon
for 30 seconds at 16 ATM
(1621kPa). (figure 1)

Figure 1 Figure 2 • Results sub-optimal. (figure 2)

• Lesions which initially appear as either treatable with PTCA or by stenting may benefit
from pre-treatment with the RotablatorTM Rotational Atherectomy System.
• Using Rotablator System may favorably impact complications, acute angiographic
results, TLR and angiographic restenosis in calcified and complex lesions.1

• Asymmetrical stent expansion occurs in up to 50% of cases where calcium is not

treated before stent deployment.2

1.Hoffman R, et al. Comparative Early and Nine-Month Results of Rotational Atherectomy, Stents and the Combination of Both for Calcified Lesions
in Large Coronary Arteries. Am J. Cardiology; March 1, 1998: vol. 81, :552-557
2.Moussa, Moses, Columbo et al. Coronary Stenting After Rotational Atherectomy in Calcified and Complex Lesions. Circulation 1997; 96:128-136

Results from case studies are not predictive of results in other cases. Results in other cases may vary.
Case images courtesy of Dr. Arthur Lee, Santa Clara Valley Medical Center, Kaiser Permanente, San Jose, CA

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RotablatorTM
Rotational Atherectomy System

Mechanism of Action

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 Mechanism of Action

Porcine Model*

Angioplasty result with vessel injury RotablatorTM System result with minimal vessel injury

Intended PTCRA benefits

• Minimizes vessel wall stretch and elastic recoil
• Eliminates vessel barotrauma
• Produces a smooth lumen/channel
• Facilitates stent delivery and expansion

*Porcine model results may not necessarily be indicative of clinical performance.

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 IVUS Image

Post-PTCA Procedure Post-RotablatorTM System

Procedure
Results from case studies are not predictive of results in other cases. Results in other cases may vary.
All photographs taken by Boston Scientific Corporation.
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 RotablatorTM
Rotational Atherectomy System

Cautions, Indications, Contraindications

Prior to use, please see the complete ‘Directions For Use’ for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events and Operator’s Instructions.

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 Indications, Precautions, Contraindications
The following indications, precautions and contraindications are abbreviated. The full wording can be found on the last slide of this presentation or the
Directions for Use (DFU) found in the product package.

Percutaneous rotational coronary angioplasty with the RotablatorTM system, as a sole therapy or with
adjunctive balloon angioplasty, is indicated in patients with coronary artery disease who are acceptable
candidates for coronary artery bypass graft surgery and who meet one of the following selection criteria:

• Single vessel atherosclerotic coronary artery disease with a stenosis that can be passed with a guide wire
Intended
• Multiple vessel coronary artery disease that in the physician’s judgment does not pose undue risk to the patient
Use/Indications
for Use • Certain patients who have had prior percutaneous transluminal coronary angioplasty (PTCA), and who have a
restenosis of the native vessel; or,

• Native vessel atherosclerotic coronary artery disease that is less than 25mm

• Ejection fraction less than 30%

• Lesions longer than 25mm

Precautions • Angulated lesions

• Recommend temporary pacemaker in the RCA and dominant Cx
• Rotablator System use should only be carried out at hospitals where emergency bypass surgery can be immediately
performed in the event of a potentially injurious or life threatening complication.

• Saphenous Vein Grafts

• Last Remaining Vessel
• Thrombus
Contraindications • Significant Dissection
• Non-surgical candidates

Prior to use, please see the complete ‘Directions For Use’ for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events and Operator’s Instructions.

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 RotablatorTM
Rotational Atherectomy System

Rotational Atherectomy Overview

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 Rotational Atherectomy

Differential Cutting
• The RotablatorTM Atherectomy
System is designed to ablate
the inelastic, calcified,
atherosclerotic tissue making
up plaque in coronary arteries
Elastic tissue • All plaque is inelastic
• Helpful analogies:
– Shaving
– A nail file

Inelastic tissue
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 Differential Cutting
Animation

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 Rotational Atherectomy

Orthogonal displacement
of friction
• The turning burr of the RotablatorTM
System facilitates burr advancement
through the arteries and burr extraction

• Helpful analogies
– Removing a cork from a champagne bottle
– Taking a ring off a finger

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 Rotational Atherectomy

Plaque is ablated into

small particles called
microparticles:
• The size of the
microparticles is less
than 5 microns (smaller
than a red blood cell)

• The microparticles are

picked up by the RES
(Reticuloendothelial System)

• Embolic protection filters designed for

100+ microns

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 Rotational Atherectomy

• With ablation of plaque burden, less pressure is required for balloon

expansion1
• Removes plaque in bifurcation lesions instead of shifting it to the side
branch2

1. Levin, T.W., et.al., Cathet. Cardiovasc. Diagn. 45: 122-130, 1998.

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2. Walton, A.S., et.al., American Journal of Cardiology, 1996, 77: 370-373. IC-109205-AA
 RotablatorTM
Rotational Atherectomy System

Hardware Components Overview

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 Hardware

Console DynaGlide™ foot pedal

Compressed air or nitrogen

Tank, regulators, attachments

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 RotablatorTM Rotational Atherectomy System
Rotablator System Console

Procedure timer Reset button

Rotational speed
Turbine pressure
display (tachometer)
gauge (delivered
to advancer)

Event timer

Turbine
pressure control
knob
Advancer fiber optic (adjusts RPM)
tachometer connector
Power switch

DynaGlide™ Connector
Power lamp

Advancer turbine
(pneumatic) connector

See DFU for Rotablator System Console for full instructions for use.

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 Air Supply Set Up

Dual Gauge Regulator Byrne

• Monitors gas delivered to console (90 – 110 PSI / 620.5-758.4 kPa)
• Monitors gas contained in tank (minimum 500 PSI / 3447 kPa per case)

Cylinder Tank
 Compressed
Air or Nitrogen

Power Cord DynaGlide™

Connectors IC-109205-AA
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 Foot Pedal

DynaGlide™ Button

DynaGlide indicator
illuminated on RPM
display on console

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 Foot Pedal

Serves as an On / Off control

for either Compressed Air or
Nitrogen to the turbine to
spin the RotablatorTM System
turbine and Burr

* Highlighted item is the actual Foot Pedal

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 DynaGlide™ Foot Switch

 DynaGlide mode provides

controlled low speed rotation
(cuts RPMs in half)
 Facilitates RotablatorTM
Rotational Atherectomy
System catheter exchange
 Only used to remove
catheters, never to advance
catheter to lesion
 When in DynaGlide mode,
the burr will not stall when
>15,000 RPM decrease for
1/2 second is experienced
 DynaGlide activated with
button on foot pedal
 DynaGlide indicator
illuminated on RPM display
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 RotablatorTM
Rotational Atherectomy System

Disposable Components Overview

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 Disposables

Components

Advancer Burr catheter

WireClipTM Torquer
& Guidewires IC-109205-AA
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 RotablatorTM RotalinkTM Advancer

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 RotalinkTM Exchangeable Catheter

Catheter
• 135 cm in length
• Sheath is .058” (1.47 mm)
Burr
• Elliptical shaped with 2,000 to 3,000 microscopic diamond crystals on the
distal edge. The proximal surface of the burr is smooth
• The brass burr is nickel coated
• The diamond crystals are 20 microns in size, with only 5 microns extruding
from the nickel coating
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 WireClipTM Torquer

WireClipTM Torquer

Features:
• Side mount grip mechanism
• Designed specifically for
Rotawire .009” (0.23 mm)
Guidewire
• Aids in torquing guidewire
• Intended to prevent guide-
Guidewire wire from spinning when
brake defeat is activated

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 Rotawire™ Floppy Guide Wire

330 cm total length

0.014’’ = 0.36 mm
0.005’’= 0.13 mm
0.0077’’= 0.20mm
0.009’’ = 0.23 mm

• Flexible and torqueable to enhance navigation

• Significantly reduced guidewire bias

• Short Spring Tip (2.2 cm)

• Light rail support

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 Rotawire™ Extra Support Guide Wire

330 cm total length

0.014’’ = 0.36 mm
0.005’’= 0.13 mm
0.009’’ = 0.23 mm

• Spring Tip (2.6 cm)

• Lead wire for those physicians requiring a “stiffer” wire

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 Burr Size and Guide Selection

Quick Reference Burr Guide

Physician Considerations

• Guide catheter with side holes

• Guide catheter that provides coaxial
engagement will reduce unfavorable
guidewire bias
• Guide catheter to accommodate the
final burr size to be utilized

Recommended Curves*

* Avoid abrupt primary and secondary curves.

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 RotablatorTM
Rotational Atherectomy System

Set-Up Information

Prior to use, please see the complete ‘Directions For Use’ for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events and Operator’s Instructions.

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 System Set Up

A. Connect air supply hose to compressed air or nitrogen

(at least 500PSI / 3447 kPa in tank per procedure; 90
– 110 PSI / 620.5-758.4 kPa flowing to console)
B. Connect DynaglideTM Foot Pedal hoses – green and
blue to back of the console).
C. Plug in console and turn on power switch
D. Connect fibe optic tachometer cables from advancer to
front of console (black)
E. Connect Advancer air line to front of the console. (Not
pictured)
Prior to use, please see the complete ‘Directions For Use’ for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events and Operator’s Instructions.

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Device Prep

Important packaging/ prep reminder for the

RotablatorTM RotalinkTM Plus Pre-Connected
Exchangeable Burr Catheter and Burr
Advancing Device

• The directions for use (DFU) specify that after dropping the
product onto the sterile field, the next step is to “gently remove
the distal gripper from the burr.”
• The distal gripper is shown in the photo at left. This plastic
protector holds the burr so that the handshake connection
does not get retracted up into the sheath.
• Note: If the distal gripper is not removed before moving the
advancer knob, the drive shaft coil could be damaged/kinked
and the handshake connection could be loosened and/or
damaged. This may also result in difficulty loading the Burr
onto the Rotawire due to a kink in the drive shaft coil

When using a Rotablator Advancer and a Rotalink Catheter (provided

Photo of distal gripper taken by Boston Scientific
separately), the two should be connected prior to removing the distal gripper. 
Then, after connection, the next step is to “gently remove the distal gripper
from the burr.”

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 RotalinkTM Catheter Connection

Note:
If the catheter connector is not visible, it is most likely inside the catheter
body. Uncoil the drive shaft and gently push the burr towards the sheath until the
connector is visible as it exits the proximal end of the catheter body.
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 D.R.A.W. – Pre Procedure Test

• Drip – Saline drip from bottom of advancer and catheter*

• Rotate – Burr is rotating and RPMs are stabile**

• Advancer – Free movement of advancer knob

• Wire – Wire is visible and brake is functioning

* Never operate the Rotablator Advancer without saline infusion. Flowing saline is essential for cooling and
lubricating the working parts of the advancer. Operating the advancer without proper saline infusion may result in
permanent damage to the Rotablator advancer

**Do not allow the burr to remain in one location while rotating at high speeds, as this may lead to wear of
the guide wire (for instance: the burr may cut the Rota wire when rotating in the same position on the wire
for extended periods of time). Gently advance or retract the burr while it is in a high-speed rotary motion.

Prior to use, please see the complete ‘Directions For Use’ for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events and Operator’s Instructions.

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 RotablatorTM
Rotational Atherectomy System

Procedural Information

Prior to use, please see the complete ‘Directions For Use’ for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events and Operator’s Instructions.

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 Key Procedural Steps

Burr Positioning (Physician considerations)

• Lock advancer knob 2 to 3 cm forward before advancing burr

into guide catheter

• Advance burr forward while holding the wire

• When burr is proximal to lesion, relieve any forward tension on

drive shaft by unlocking advancer knob and pulling it back.

• Burr Speed
• Small burrs (1.25-2.0 mm) 160,000 – 180,000 RPM
• Large burrs (≥ 2.15 mm) 140,000 – 160,000 RPM

Prior to use, please see the complete ‘Directions For Use’ for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events and Operator’s Instructions.

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 Key Procedural Steps

Burr movement (Physician Considerations)

• Advance burr no more than 3 cm back and

forth, moving forward only where there is
light resistance

• Maintain RPMs within 5,000 of platform

speed
• Limit runs to <30 seconds with rest
periods in between

• Total rotational procedure time should not

exceed five minutes.

• Upsize burr if necessary, in

.25 cm increments

• Finish with one polishing run.

• No RPM drop
• Little to no resistance
Prior to use, please see the complete ‘Directions For Use’ for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events and Operator’s Instructions.

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Key Procedural Steps

Important reminder on Burr

movement
• The directions for use (DFU) for the
RotablatorTM RotalinkTM Burr Catheters
specify to always keep the burr advancing
or retracting while it is rotating.
• Maintaining the burr in one location while it
is rotating may lead to excessive tissue
removal or damage to the Rotablator
system.
• System damage could include wire damage
Illustration by Boston Scientific
or fracture.

Prior to use, please see the complete ‘Directions For Use’ for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events and Operator’s Instructions.

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 Feedback During Ablation

Tactile
Advancer knob resistance or
excessive driveshaft vibration
due to:
• Excessive load on burr
• Burr advanced too rapidly
• A kink in the drive shaft coil
• The burr is too large for the lesion/artery

Visual
• Smooth advancement under fluoroscopy
• Contrast injection to discern lesion contours and borders

Auditory
• Pitch changes relative to resistance encountered
by the burr

Prior to use, please see the complete ‘Directions For Use’ for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events and Operator’s Instructions.

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 Key Procedural Steps

Ablation Procedure Tips (Physician Considerations)

• Do not over-tighten Y-adapter

• Avoid dottering
• Never stop burr in lesion
• Never stop burr distal to lesion
• Never adjust RPMs during ablation
• Never advance rotating burr to point
of contact with the guidewire
spring tip
• Do not allow the burr to remain in
one location while rotating
at high speeds
• Gently advance or retract the burr
while it is at high speed rotary motion
• Avoid burring in the guide catheter
Prior to use, please see the complete ‘Directions For Use’ for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events and Operator’s Instructions.

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Key Procedural Steps

Important reminder on the Y-adaptor

• The directions for use (DFU) for the RotablatorTM
RotalinkTM Burr Catheters specify to advance the
catheter through the hemostasis valve (Y-
adaptor) and gently tighten the valve to prevent
bleeding around the catheter sheath.
• The hemostasis valve should be closed just tight
enough to prevent blood loss, but still allow the
RotaLink Sheath to slide through the valve.
• If the hemostasis valve is tightened excessively, it
can crush the sheath around the drive shaft and
cause permanent damage to the RotaLink
Photo of y-adaptor taken by Boston Scientific Catheter.
• Other possible failures stemming from a too tight
hemostasis valve include a torn/split/kinked
sheath that can leak and/or inhibit fluid flow which
could cause multiple other product issues.

Prior to use, please see the complete ‘Directions For Use’ for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events and Operator’s Instructions.

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Key Procedural Steps

Diagram by Boston Scientific

Important reminder on burr distance from spring tip

• The directions for use (DFU) for the RotablatorTM RotalinkTM Burr
Catheters specify that the physician must verify that the guide
wire tip (Figure 2 Spring Tip) is distal to the lesion and will not
come in contact with the rotating burr.
• Coming into contact with the guide wire tip could cause guide
wire damage/fracture or cause the burr to be stuck on the wire
and/or in the lesion.

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 RotablatorTM
Rotational Atherectomy System

Management of Complications

For questions regarding management of complications, please consult your proctor or other
certified RotablatorTM System physician.

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Slow Flow/No Flow
Overview
• Slow flow and No flow are
observed in 5% of patients
undergoing PTCRA
• Slow flow is a diminution of
flow by 1-2 TIMI grades
from the baseline
antegrade flow
• No reflow is a cessation of
flow into the distal coronary
bed
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Potential Course of Action
• IC Nitroglycerin 100-200 mcg
bolus as tolerated
• IC Verapamil or CardeneTM
• Time
• Low pressure balloon inflation
(less than 1 ATM / 101 kPa)
• Early recognition of flow
disturbance is key
• Intermittent injections of contrast
media during ablation run for
flow interrogation
• Appropriate burr run time for
lesion and vessel complexity
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 Dissection

• Operator technique influences dissection rate greatly

• Once identified, RotablatorTM System procedure must be stopped
• Management is similar to conventional PTCA
• Dissection must be allowed to heal before the Rotablator System
can be attempted again (per DFU)

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 Abrupt Closure

• Must be distinguished from a spasm or slow flow/no flow

• Management similar to conventional PTCA which is the same

as treatment for no flow

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Perforation

Overview Potential Course of Action

• Remove the burr, leaving wire
• The mechanisms for in place
perforation include:
• Perfusion balloon
– Oversized burrs (extended inflation time)
– Guidewire bias
• Decrease ACT with medication
– Severe angles
• Monitor BP (lowering of BP can
– Improper technique indicate tamponade)
• If tamponade occurs,
a pericardiocentesis may need to be performed
• Surgery consult in some cases
• CABG

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Lodged Burr
Causes
• Oversized burr in diffuse
calcium and too much
pressure can jam
• Small burr in eccentric lesion
and too much pressure can
cause watermelon seeding
thru lesion and with no
diamonds on proximal side of
burr, no way to get back
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Potential Course of Action
• Do not attempt to start the burr
spinning once it is stuck. Take an
angiogram to determine burr position
• Nitro, cough and time
• DynaGlide™: Burp foot pedal while
gently pulling catheter shaft. Brief
spurt of energy and gentle pull back
simultaneously
• Compliant balloon beside burr w/
low pressure (1 ATM / 101 kPa)
inflation to open up and dislodge
burr
• 0.014” (0.36 mm) buddy wire
• Surgery if required
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 Frequently Asked Questions

White Substance on Wire The Advancer was Running, but

• A white substance, called
HYSTRENETM, is intentionally coated
on the RotaWire™ Guide Wires
• HYSTRENETM is a palm oil derivative
• Bio-compatible
• Purpose is to facilitate initial burr
passage over dry wire
• Do not wipe the compound off the wire
Now is Not
• Check all connections
• Check air source – make sure it is on
and delivering 90 -110 PSI (620.5 –
758.4 kPa)
• Likely a lack of saline allowed “burn
out,” which happens quickly
• New advancer needed if no saline drip
through advancer is discovered

Hystrene is a trademark of Crompton Corporation

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 Frequently Asked Questions
Console Problems
• Ensure all connections are secure
• Ensure adequate air supply: at least
500 PSI (3447 kPa) in tank, 90 -110
PSI (620.5 – 758.4 kPa) delivered to
console
• Ensure console is plugged in, correctly
set-up and connected
• Double check airflow regulator to
secure tank connections and quantity
of pressure output tank
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Stall light comes On
• As a safety feature, the system
automatically stalls when there is a
>15,000 rpm drop for a ½ second or
more
• Ensure the burr is not lodged
• Pull back and re-platform proximal to
the lesion
• Ensure connections are secure
• Ensure air supply
• Ensure saline flow
Note: Advancer could be burned out if no
saline is flowing – new advancer needed.
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Frequently Asked Questions

Contemporary Use of RotablatorTM Rotational

Atherectomy System
• One burr approach is common: 1.25 mm, 1.50 mm, 1.75 mm

• Only allow for less than 5,000 RPM drop

• 15-30 second runs(average)

• Plaque modification vs. de-bulking

• Saline infusion “cocktail” per hospital protocol

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RotablatorTM Rotational Atherectomy System
Abbreviated Statement

Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.
INTENDED USE/INDICATIONS FOR USE
Percutaneous rotational coronary angioplasty with the Rotablator Rotational Atherectomy System, as a sole therapy or with adjunctive balloon angioplasty, is indicated in patients with coronary
artery disease who are acceptable candidates for coronary artery bypass graft surgery and who meet one of the following selection criteria:
Single vessel atherosclerotic coronary artery disease with a stenosis that can be passed with a guidewire;
Multiple vessel coronary artery disease that in the physician’s judgment does not pose undue risk to the patient;
Certain patients who have had prior percutaneous transluminal coronary angioplasty (PTCA), and who have a restenosis of the native vessel; or,
Native vessel atherosclerotic coronary artery disease that is less than 25 mm in length.
CONTRAINDICATIONS AND RESTRICTIONS:
Contraindications
1. Occlusions through which a guidewire will not pass.
2. Last remaining vessel with compromised left ventricular function.
3. Saphenous vein grafts.
4. Angiographic evidence of thrombus prior to treatment with the Rotablator System. Such patients may be treated with thrombolytics (e.g., Urokinase). When the thrombus has been resolved for two
to four weeks, the lesion may be treated with the Rotablator system.
5. Angiographic evidence of significant dissection at the treatment site. The patient may be treated conservatively for approximately four weeks to permit the dissection to heal before treating the
lesion with the Rotablator System.

WARNINGS:
The risks of Rotational Atherectomy can be reduced if the device and associated accessories are used in the appropriate patient population by a physician who has had adequate training.

The use of Rotablator for in-stent restenosis might lead to damage of stent components and/or Rotablator Systems, which may lead to patient injury.
PRECAUTIONS
Treating certain types and/or locations of lesions or patients with certain conditions is inherently riskier, regardless of the therapeutic device being used. For many of these applications, relatively
few cases have been carried out using the Rotablator System. Physicians should be aware of the higher risk when treating such patients and the lack of scientific evidence for treatment in the
following applications:
Patients who are not candidates for coronary artery bypass surgery;
Patients with severe, diffuse three-vessel disease (multiple diseased vessels should be treated in separate sessions);
Patients with unprotected left main coronary artery disease;
Patients with ejection fraction less than 30%;
Lesions longer than 25mm;
Angulated (> 450) lesions;
Rotablator System use should only be carried out at hospitals where emergency bypass surgery can be immediately performed in the event of a potentially injurious or life threatening
complication.
ADVERSE EVENTS
Potential adverse reactions which may result from the use of this device include but are not limited to:
Angina or unstable angina; Arrhythmias; Bailout stenting; Cardiac perforation; Cardiac tamonade; conduction block; Coronary artery spasm; Death; Drug reaction, allergic reaction to
contrast media; Embolism (coronary, cerebral, peripheral); Hemorrhage or hematoma; Infection, local infection, systemic infection; Myocardial ischemia; Myocardial infarction (Q-wave
and non q-Wave); Pericardial effusion; Pulmonary edema/cardiogenic shock; Slow flow, no flow, abrupt vessel closure; Stroke; Vascular thrombus; Vessel trauma (dissection,
perforation, rupture or injury)
There may also be complications associated with distortion, kinks, and fracture of the guidewire and physical deterioration or malfunction of the device, which can lead to patient injury or death.
•Complications include: access site bleeding of significance, distal embolization, intimal dissection, acute vessel closure, vessel perforation or tear, ventricular perforation, emergency surgery,
contrast media reaction, stroke, slow flow, no flow, myocardial infarction, arrhythmia requiring treatment, cardiac tamponade, and death.

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Cardene is a trademark of EKR Therapeutics, Inc. Hystrene is a trademark of Crompton Corporation. IC-109205-AA