As Published in February 2010

Recent Trends in Hemodynamic Monitoring

by Anne Staylor

In critical care, the goal of hemodynamic
monitoring is to provide data that guides
treatment and prevents morbidity and
mortality of critically ill patients. Clini-
cians use hemodynamic monitoring data
to optimize the balance between tissue ox-
ygen supply and demand and effectively
combat global tissue hypoxia, shock, and
multiorgan failure in critically ill patients.
Market Outlook
Within the market for hemodynamic
monitoring products, there are two main
segments: pulmonary artery catheters
(PACs) and cardiac output (CO) monitor-
ing systems, which include minimally in-
vasive and noninvasive technologies. Over
the past 10 years, the market for hemody-
namic monitoring products has evolved,
and growth in this market is being fueled
by several factors, not the least of which
is an aging population with an increasing
number of cardiac disorders and other
conditions that could benefit from hemo-
dynamic monitoring. Growth is also being
driven by the demand for less invasive
and noninvasive technologies that mea-
sure CO, stroke volume, and other global With the advent
parameters of oxygen delivery. Current
technologies available for hemodynamic
of less invasive
monitoring include products based on and noninvasive
thermodilution, dye dilution, lithium
devices, the base
dilution, those using the Fick principle,
thoracic electrical bioimpedance, esopha- of clinicians that
geal Doppler monitoring, pulse contour can initiate cardiac
methods, ultrasonic CO monitoring, and
transesophageal echocardiography. These output monitoring
technologies are increasingly being used in has increased
place of the more invasive PAC.
exponentially.
The market for hemodynamic monitoring
will also be driven by the increasing number
of clinicians who can initiate and place these
monitoring technologies. Previously, only a
physician could initiate CO monitoring, as
PAC catheters must be inserted by a physi-
cian. But with the advent of less invasive
and noninvasive devices—which can be
used by any nurse, physician assistant, re-
spiratory therapist, cardiovascular technolo-
gist, or anesthesia technician familiar with

Exhibit 1

Estimated Worldwide Sales of Hospital-Based Less Invasive Hemodynamic Monitoring Products

$140

$120 All Others

Edwards
Sales ($millions)

$100

$80

$60

$40

$20

$0

Note: Includes sales of disposables and monitors.

SOURCE: Edwards Lifesciences

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2010 Windhover Information, an Elsevier company. All rights reserved. 1
 HEMODYNAMIC MONITORING February 2010

basic invasive pressure monitoring—the With the US hospital market for patient
base of clinicians that can initiate CO moni- monitoring dominated by industry giants
toring has increased exponentially. like Royal Philips Electronics NV’s Philips
Medical Systems Inc., General Electric
In 2009, hospital-based sales of less inva- Co.’s GE Healthcare and Draegerwerk AG’s
sive hemodynamic monitoring products Draeger Medical Inc., the biggest chal-
was well over $120 million worldwide, lenges for manufacturers of noninvasive
according to Edwards Lifesciences Corp., and minimally invasive hemodynamic
an established leader in the hemodynamic monitoring devices will be establishing
monitoring market. (See Exhibit 1.) Clinicians widespread distribution, gaining clini-
in the US have been slower to adopt the less cian trust and preference for the devices,
invasive and noninvasive hemodynamic and integrating these devices into proven
treatment algorithms and
Exhibit 2
goal-directed therapy that
Hemodynamic Monitoring Products, US Market Forecast, 2006-2012E will ultimately demon-
strate the data derived
Cardiac Out- from these devices can be
Pulmonary Annual put Monitor- Annual used to improve patient
Artery Catheter Change ing System Change Total Sales outcomes. Selected com-
Year Sales ($M) (%) Sales ($M) (%) ($M)
panies with less invasive
2006 100.4 — $22.5M — 122.9 and noninvasive hemody-
2007 98.1 -2.3 31.5 40.0 129.6 namic monitoring devices
include CardioDynam-
2008 95.8 -2.3 38.0 20.6 133.8
ics International Corp.
2009 93.7 -2.2 45.0 18.4 138.7 (acquired by SonoSite
2010 E 91.6 -2.2 52.0 15.6 143.6 Inc. in August 2009), CAS
2011 E 89.0 -2.8 60.0 15.4 149.0 Medical Systems Inc. and
newcomer Cheetah Medi-
2012 E 85.7 -3.7 69.0 15.0 154.7
cal Inc., among others.
CAGR (2007-2012E) 3.6% (See Exhibit 3.) (See Sidebar,
Cheetah Medical: Advancing
Note: Figures for cardiac output monitoring systems include noninvasive and minimally invasive products. Noninvasive Hemodynamic
SOURCE: Medtech Insight Market Report #A346, US Markets for Patient Monitoring Products, published Monitoring.)
June 2008
Edwards: A Case
Study in Trends
monitoring products than those in Europe
With its Swan-Ganz line of hemodynamic
and other countries; however, US sales of
monitoring products, Edwards has long
these technologies have been steadily grow-
been an established leader in the world-
ing and are projected to reach $69.0 mil-
wide hemodynamic monitoring market.
lion by 2012. (See Exhibit 2.) And while the
Over the last five years, the company’s
barriers to entry are high for this business,
product development strategies and sales
the prospect for future growth is significant,
of hemodynamic monitoring products have
with the worldwide potential for hemody-
provided a real-world glimpse of the trends
namic monitoring estimated by Edwards at
in the hemodynamic monitoring market.
$540 million.
With increasing demand for less invasive
technologies and with declining sales of the
Challenges Remain
Swan-Ganz line, Edwards launched its own
Noninvasive and minimally invasive less invasive technology, the FloTrac System,
hemodynamic monitoring devices have in 2005. The FloTrac System, which includes
improved greatly over the last few years, the FloTrac Sensor and Vigileo Monitor, uti-
and manufacturers have been developing lizes an existing arterial line and continuous
devices that are more accurate, simpler self-calibration to provide key flow param-
to use, and allow for earlier diagnosis of eters, including CO, stroke volume, stroke
sepsis and shock. But even with product volume variation, and systemic vascular
improvements and increasing demand resistance if central venous pressures are
for these products, challenges remain. saved into the monitor. Since launching the

2 www.ElsevierBI.com
February 2010 HEMODYNAMIC MONITORING

Exhibit 3

Selected Noninvasive and Minimally Invasive Hemodynamic Monitoring Systems

Company Product Features

Cardio- BioZ Dx Noninvasive impedance cardiography system that measures contractility, flow, fluid, and resistance
Dynamics parameters; Includes four dual sensors; Clinical indications include diagnosis of heart failure, dysp-
International nea, and resistant hypertension
CAS Medical LIFEGARD II Noninvasive hemodynamic monitor; Offers continuous CO and advanced hemodynamic parameters
Systems for immediate patient assessment; Monitor enables comparison of impedance cardiography and
electrocardiogram waveforms, tabular trends, all data, and graphical trends (blood pressure, CO/
cardiac index, and heart rate viewable on all screens)

Cheetah NICOM System Noninvasive hemodynamic monitor based on proprietary BIOREACTANCE technology that uses phase
Medical instead of amplitude to measure blood flow–induced changes in electrical current as it goes through the
chest; Offers continuous CO and advanced hemodynamic parameters for immediate patient assessment
Deltex Medical CardioQ Includes a monitor and disposable probe; Monitor displays blood flow velocity profiles; The patented
Sciences Inc. six-millimeter probe consists of two continuous-wave Doppler transducers that are inserted into the
patient’s esophagus near the descending aorta
Edwards FloTrac Arterial waveform analysis sensor system; The FloTrac sensor, which is connected to an arterial line,
Lifesciences is used along with the company's Vigileo Monitoring System for monitoring continuous CO, stroke
volume, stroke volume variation, and systemic vascular resistance; The FloTrac differs from other
systems in that it does not require calibration with another method
Hemo Hemodynamic Impedance cardiography system for the noninvasive assessment, monitoring, management, and mod-
Sapiens Inc. and Oxygen Trans- eling of a patient’s hemodynamics and oxygen transport dynamics; Different options are available
port & Manage- for patient subgroups including adult males and postmenopausal females, neonatal and pediatric
ment (HOTMAN) patients, pregnant women, and those in the childbearing age range
LiDCO LiDCOplus Uses radial arterial pressure wave analysis to derive a real-time CO reading; Hemodynamic monitor
Group PLC analyzes the signal from a radial artery pressure sensor to derive CO and uses a lithium dilution tech-
nique to calibrate the system; Monitoring begins with a subtherapeutic dose of lithium chloride, which
is injected in the venous circulation; An ion-selective electrode sensor in the arterial line is used to
measure the dilution curve and calibrate the system; Calibration is maintained for eight to 12 hours
Noninvasive IQ2 Utilizes thoracic electrical bioimpedance technology to measure electrical impedance changes
Medical throughout the thorax as aortic blood volume increases and decreases in response to the beating
Technologies heart; The company's patented technology plots power, time, and frequency of impedance changes
Inc. to create a three-dimensional view of cardiac function; The 11-parameter system provides real-time
cardiac, hemodynamic, and pulmonary data and has emergency department, hospital, nursing
home, and outpatient applications
Pulsion PiCCO2 Minimally invasive hemodynamic monitoring system; Access via femoral, brachial, or axillary artery;
Medical Performs pulse contour analysis on thermodilution waveforms to generate CO; Requires bolus injec-
Systems tion for calibration; Provides long-term monitoring capabilities and continuous, real-time monitoring;
Suitable for pediatric care
Respironics NICO The monitor measures CO based on changes in respiratory carbon dioxide concentration, which
Inc./Philips is caused by a brief period of rebreathing; The measurement of CO is accomplished by interpret-
Medical ing data collected by proprietary sensors that measure flow, airway pressure, and carbon dioxide
Systems/Royal concentration; These signals are then combined to calculate carbon dioxide elimination; Using these
Philips variables, a technique known as Fick partial rebreathing is applied to calculate CO; Monitor may be
Electronics used only with mechanically ventilated patients and requires artificial respiration; Not suitable for
pediatric patients or those with lung disease; Does not provide long-term or real-time monitoring
Väsamed AcQtrac System The noninvasive system uses thoracic impedance cardiography to present a unique cardiovascu-
logram waveform that illustrates the mechanical function of the cardiovascular system; Uses four
pre-gelled electrodes; Monitors 12 cardiac parameters

Notes: The BioZ Dx product is the result of a codevelopment partnership and original equipment manufacturer agreement with Philips Medical
Systems/Royal Philips Electronics. In May 2007, Analogic Corp. and CAS Medical Systems announced a cobranding agreement, giving CAS Medical
Systems worldwide exclusive rights to market and sell Analogic’s LIFEGARD family of noninvasive patient monitors. In March 2001, Medis GMBH
entered into a technology licensing relationship with Analogic. Under the agreement, Medis licensed its impedance cardiography circuit board and
software design to Analogic as a key component to the LIFEGARD Monitor. (In June 2004, CardioDynamics International acquired Medis; the com-
pany receives a licensing fee each time an Analogic impedance cardiography device is sold. SonoSite acquired Cardiodynamices in August 2009.)
In March 2008, Royal Philips Electronics completed the acquisition of Respironics, which acquired Novametrix Medical Systems Inc.—developer of
the NICO System—in 2002.

SOURCE: Medtech Insight Report #A346

©
2010 Windhover Information, an Elsevier company. All rights reserved. 3
 HEMODYNAMIC MONITORING February 2010

FloTrac System, the company has capitalized
on its reputation and leadership position es-
tablished with the Swan-Ganz Catheter and
has captured 54% of the global market share
for less invasive hemodynamic monitoring
products, according to company estimates.
(See Exhibit 4.) At the same time, growth op-
Exhibit 4
Estimated Worldwide Market Share of Hospital-Based Less Invasive
Hemodynamic Monitoring Products
Others
16%
54% Edwards
30% FloTrac
Pulsion
PiCCO2
Note: Includes sales of disposables and monitors.
SOURCE: Edwards Lifesciences
portunities remain in the intensive care unit
(ICU) and high-risk surgery markets. (See
Exhibit 5.)
Like other manufacturers of noninvasive
and less invasive hemodynamic monitor-
ing devices, Edwards has been develop-
ing product enhancements to the FloTrac
System to address the evolving needs of
critical care professionals working in an
increasingly understaffed, complex, and
demanding environment. Since 2005, Ed-
wards has added more user-friendly pa-
tient trending and analysis to the FloTrac
System and launched a third-generation
algorithm that enhanced the FloTrac Sys-
tem’s accuracy when used in patients with
sepsis and other critical illnesses.
In the second quarter of 2010, Edwards
is planning to launch a new integrated
hardware platform, the EV1000, which will
ultimately consolidate all the company’s
parameters, including the FloTrac Sen-
sor and the PreSep and PediaSat Oximetry
Catheters, into a simpler, more intuitive
informational display. According to the
company, the EV1000 will have an Apple-
like interface, and a user-friendly touch
screen that dynamically integrates several
hemodynamic parameters into different
color “zones,” which will allow clinicians
to quickly view the overall hemodynamic
status of a patient from across a room.

Exhibit 5 The company is also planning to launch

the VolumeView Catheter in 2010, a tech-
Estimated Worldwide Shares of Addressable Market for Hospital-
nology that allows bedside assessment
Based Less Invasive Monitoring Products
of pulmonary edema. The VolumeView
Catheter measures extravascular lung
water and displays it on the monitor using
a graphic representation of the lungs. Pul-
Edwards sion Medical Systems AG, a market leader
All Others Lifesciences in hemodynamic monitoring in Europe,
also offers a display that features a type
of dynamic status indicator as part of its
PiCCO2 Monitor. The technology, called
Unreached Spidervision, enables clinicians to simul-
ICU Unreached taneously view different hemodynamic
High-risk parameters to see if they are outside the
Surgery “target range.” The PiCCO2 also features a
measure of extravascular lung water. (See
“Hemodynamic Monitoring Enters a New
Era,” Medtech Insight, April 2008.)
Note: Includes sales of disposables and monitors.
In January 2010, Edwards announced that
SOURCE: Edwards Lifesciences it signed a licensing agreement with Philips

4 www.ElsevierBI.com
February 2010 HEMODYNAMIC MONITORING

Medical Systems to integrate its oximetry
technology into Philips’ IntelliVue Patient
Monitors. This is the first modular agree-
ment for Edwards, which has previously
only offered its monitoring technology for
use with its own proprietary stand-alone
monitors. In the future, Edwards says it
plans to make its critical care parameters
more widely accessible through licensing in
an effort to drive more sales of its disposable
catheters.
The company also has plans to launch a new
continuous glucose monitoring system on the
US market in 2010. Edwards has been code-
veloping the device with DexCom Inc. for use
in critically ill adults in the hospital environ-
ment. (See “Edwards Lifesciences and DexCom
Join Forces in New Critical Care Growth Market,”
IN VIVO, December 2008.) The device per-
forms one reading every 7.5 minutes and is
indicated for automatic, real-time monitoring
and trending of blood glucose concentration.

CHEETAH MEDICAL:
ADVANCING NONINVASIVE HEMODYNAMIC MONITORING
In an ideal world, hemodynamic
monitoring technology would
be completely noninvasive, con-
tinuous, affordable, easy to use
and understand, and as accurate
as the gold-standard pulmonary
artery catheter. One company that
believes it has achieved this ideal
is Tel Aviv, Israel-based Cheetah
Medical. The company’s NICOM
System is a noninvasive hemody-
namic monitoring device based
on Cheetah’s proprietary BIOREAC-
TANCE technology. At first glance,
BIOREACTANCE looks very similar
to thoracic bioimpedance, as both
technologies use electrodes placed
on the patient’s chest to deliver an
electrical current across the thorax.
However, the comparison stops
there, according to Cheetah’s CEO,
Yoav Avidor, MD. “BIOREACTANCE
primarily differs from bioimpedance
technology in that it uses phase
instead of amplitude to measure
blood flow-induced changes in
electrical current as it goes through
the chest, “ says Dr. Avidor. “If you
correlate the change in phase and
the degree of the change to flow,
there’s actually a very accurate,
consistent relationship.” Although
accuracy has been an issue for some
noninvasive devices, the company
says the NICOM System has been
validated in several clinical studies
and is the only noninvasive product
that was US Food & Drug Admin-
istration (FDA) cleared using the
pulmonary artery catheter (Swan-
Ganz) as a predicate device.
Some have likened BIOREAC-
TANCE technology to the frequen-
cy modulation (FM) used in radio
transmissions, since the phase
modulation used in NICOM and
FM are closely related. By detect-
ing changes in signal frequency
(FM) rather than changes in signal
amplitude (AM), FM radio allows
greater signal fidelity. According
to Dr. Avidor, phase (as frequency)
provides physical advantages
that can then be translated into
monitoring advantages, accuracy
advantages, and a different type
of care.
For example, phase is not im-
pacted by the location of elec-
trodes on the body, which can be
a big advantage in the operating
room and ICU where patients can
have limited areas available for
electrode placement. Also, certain
physical conditions such as obesity
and pleural effusion do not impact
phase, but can be a problem for
bioimpedance because they mod-
ify the amplitude that is reported.
As far as motion, Avidor says the
NICOM System is highly motion
tolerant, allowing clinicians to con-
duct continuous hemodynamic
monitoring and stress testing or
monitor patients that are awake
or who are moving continuously.
And although things like dialysis
machines, monitors, and pace-
makers can induce voltage and be
a problem for bioimpedance, Avi-
dor says this is not a problem with
BIOREACTANCE. Phase is filterable
while amplitude is not, so you can
filter out the electrical noise from
interfering technologies because
they’re not in the same frequency
domain, according to Avidor.
The company is initially tar-
geting the ICU and anesthesia
markets, but Avidor believes the
technology also addresses several
significant unmet needs in step-
down units and emergency medi-
cine. BIOREACTANCE is also being
used in outpatient cardiology for
heart failure patients to determine
cardiac response to stress testing
and for optimization of biven-
tricular pacemakers. The NICOM
System has been commercially
available in Europe for 18 months
and received clearance for use in
Canada in November 2009. The
device received FDA clearance
in the US in January 2008 and is
being used by several leading US
hospitals, including Ohio State
University, Memorial Sloan-Ketter-
ing Cancer Center, Weill Cornell
Medical Center, and Dartmouth-
Hitchcock Medical Center. Avidor
says the company opened its first
commercial account in the US in
January 2009. Cheetah plans to
use recent financing to expand
distribution for the device and
carry out various large-scale
clinical studies to demonstrate
the value of continuous hemody-
namic monitoring in large, less
traditional sites of care.

©
2010 Windhover Information, an Elsevier company. All rights reserved. 5
 HEMODYNAMIC MONITORING
Studies have shown that hospitalized pa-
tients can be at a higher risk of infection and
other complications if their blood glucose
level is elevated for prolonged periods. Cur-
rently, clinicians manage patients’ glucose
levels by manually obtaining intermittent
samples over various periods of time, typi-
cally every one to four hours. According
to the company, the trending provided by
Exhibit 6
Edwards Lifesciences: Revenue Model for Hemodynamic Monitoring, 2006–2011E
2006 2007 2008 2009E 2010E
Hemodynamic $175M $199M $230M $225M $247M
Monitoring
Year/Year Growth 14% 14% -2% 10%
FloTrac $15M $34M $44M $58M $66M
Year/Year Growth 127% 29% 32% 14%
Notes: Revenue for hemodynamic monitoring includes FloTrac.
SOURCE: Morgan Stanley Research, July 21, 2009
continuous glucose monitoring may reduce
nursing time and provide a new level of
insight into serum glucose variability that
enables clinicians to more effectively imple-
ment glycemic control in critically ill and
hospitalized patients. Edward’s continuous
glucose monitoring system received CE
Mark in November 2009 and is commercially
available in the European Union. The com-
pany is currently conducting market evalu-
ations and implementing a “controlled” roll
out at a limited number of European sites to
make sure clinicians are educated appropri-
ately and are using it correctly in high-risk
patients. According to an Edwards’ spokes-
person, the company is hoping to receive US
regulatory clearance for the glucose monitor-
ing system sometime in mid-2010.
With the addition of continuous glucose
monitoring, Edwards gains a potentially
high-growth product for its hospital moni-
toring business. According to the company,
the worldwide market for continuous glu-
cose monitoring of critically ill patients was
an estimated $200 million in 2009. Overall,
with new product introductions and con-
tinued growth in its disposables business,
sales of Edward’s hemodynamic monitoring
6 www.ElsevierBI.com
February 2010
products are projected to increase by 10% in
2010. (See Exhibit 6.)
Assessing the Future
Growth in the market for hemodynamic
monitoring products will continue as manu-
facturers develop new parameters and prod-
uct enhancements that make noninvasive
and less invasive hemodynamic monitors
more accurate, simpler
to use, easier to under-
stand and interpret,
and more available to a
wider base of clinicians.
2011E Looking to the future,
$272M critical care monitoring
will go beyond hemo-
10% dynamic monitors that
measure global param-
eters of oxygen delivery
$74M as manufacturers and
researchers develop new
13%
technologies that allow
for earlier diagnosis of
sepsis and shock.
There is burgeoning
interest in emerg-
ing technologies that monitor changes in
microcirculatory flow and more “down-
stream” markers of effective resuscitation,
including regional tissue oxygenation, or-
gan perfusion, lactic acid, and biomarkers.
As this field matures, researchers will
continue to add to their knowledge of the
physiology of critical illness, an area where
much remains unknown. What’s clear at the
moment is that current monitoring technolo-
gies provide only one piece of the patient
puzzle. Future advances will be driven by an
expanded understanding of critical illness
at the molecular level and new technologies
will evolve accordingly.
[A#2010400014]
Anne Staylor is Senior Editor for Medtech Insight
(E-mail: A.Staylor@Elsevier.com)
RELATED READING
Device Opportunities in the Diabetes Treatment Market, Medtech
Insight, October 2009 [A#2009400080]
Edwards Lifesciences and DexCom Join Forces in New Critical
Care Growth Market, IN VIVO, December 2008 [A#2008800196]
Hemodynamic Monitoring Enters a New Era, Medtech Insight, April,
2008 [A#2008400027]
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