MEDICAL DEVICE INNOVATION - Medical Device Daily

MEDICAL DEVICE INNOVATION 2010
Cheetah’s Nicom system shows
good results in stress test study
By OMAR FORD
Medical Device Daily Staff Writer
A new study could give heart stress tests like Cheetah
Medical’s (Tel Aviv, Israel) a chance at becoming the standard
for patient care, replacing expensive and more difficult
testing options.
The study evaluated bioreactance-based noninvasive
measurements during exertion; identified abnormalities of
cardiovascular function and how it might be useful for
indexing disease severity, prognostication, and for tracking
responses to treatment in clinical practice and trials.
Nearly 240 patients were observed in the study, which
compared Cheetah Medical’s Nicom System to the traditional
method of measuring oxygen consumption, through
Vo2 tests which are obtained from analysis of expired
gases. Results were published in the Journal of Cardiac
Failure, the official journal of the Heart Failure Society of
America (St. Paul, Minnesota) and the Japanese Heart Failure
Society.
“The issue is to determine a patient’s rate of heart failure,”
Cheetah Medical CEO Yoav Avidor told Medical Device
Daily.
Bioreactance technologies are non-invasive and measure
cardiac output, and other hemodynamic variables such
as stroke volume, cardiac index, left ventricular ejection
time and thoracic fluid content.
The company said that the results from both methods
correlated extremely well, demonstrating the potential to
use the Nicom system to routinely monitor heart failure
patients without the significant limitations of expired
breath gas technologies.
Cheetah said the study gave evidence Bioreactancebased
noninvasive measurements of CO at rest and during
exertion identified abnormalities of cardiovascular function
consistent with those identified by VO2 and in prior
studies using invasive CO measurements. This technique
might therefore be useful for indexing disease severity,
prognostication, and for tracking responses to treatment in
clinical practice and in clinical trials.
The problem with expired breath technologies and
VO2 tests is that they are expensive and some physicians
and clinicians have very limited experience with this type
of technology.
“These tests aren’t readily available and are expensive,”
Avidor told MDD. “The other problem is that these tests are
very difficult because you could stress the heart while
administering the test.”
But the Nicom system, which is FDA cleared and has
been given the CE mark, is a much smaller and inexpensive
way to measure cardiac output.
“The sensors for the device are four double electrodes
37
similar in concept to an ECG and are placed on the back of
the patient, creating a square like shape,” Avidor told MDD.
“What we do is non invasively measure cardiac output,
without putting too much stress on the heart.”
The philosophy behind the device is to observe organ
perfusion and oxygen delivery because these two factors
drive changes in cardiac function, vascular tone, blood
pressure respiration and urine output. Therefore, monitoring
oxygen delivery provides key insight into the patient’s
hemodynamic status in a more accurate and real-time fashion
than any dependant proxy such as blood pressure,
urine output, heart and the like.
The company said that this information provides key
clinical insight, especially in challenging hemodynamic
clinical settings, or in those where such challenges may
quickly occur and rapidly deteriorate. Understanding oxygen
delivery in real time means understanding how to treat
the patients’ heart function, fluid balance and respiratory
function.
But what happens next for the company and the
device The answer is quite simple according to Daniel
Burkhoff, MD, PhD. an Adjunct Associate Professor of
Medicine at Columbia University Medical School (New
York).
“With the results of this study showing good correlations
to oxygen consumption and several prior independent
studies showing that peak cardiac power can be even
more predictive of outcomes, we are encouraged that we
will see these measurements used more often in a variety
of settings,” he said. “Currently, the NICOM appears to offer
the simplest solution for clinicians to measure cardiac output
and power during exercise. We are planning a large
multicenter study to confirm the prior smaller studies to
prove the utility of peak cardiac power for predicting the
risks of hospitalizations, the need for heart transplant, left
ventricular assist devices and mortality.”
Cheetah Medical specializes in non invasive cardiac
output and hemodynamic monitoring. The company is private
and was founded in 2001.
(This story originally appeared in the Oct. 12, 2009, edition
of Medical Device Daily)
To subscribe, please call MEDICAL DEVICE DAILY Customer Service at (800) 888-3912; outside the U.S. and Canada, call (404) 262-5547.
Copyright © 2010 AHC Media LLC. Reproduction is strictly prohibited.