April 29, 2008 - Nearly a million Americans -
mostly senior citizens - will suffer a heart attack this year and about
half will die. The odds may swing in a more positive direction, however,
with the Food and Drug Administration's approval today of the marketing
of a device that a doctor can use to see inside a blood vessel to assess
the fat content of the plaque which builds up on the wall of the
coronary arteries.
Plaque is a deposit made up of cholesterol-rich
fat, calcium, and other substances found in the blood. As plaque
accumulates on the artery wall, it reduces blood flow to the heart
muscle and increases the risk of blood clots which can lead to a heart
attack.
Many heart attacks occur when a fatty coronary
plaque ruptures, forming dangerous blood clots. Pathologic studies of
patients who died from heart attack have identified a large lipid
(fatty) core among features of coronary artery disease that were
associated with plaque rupture and thrombosis (blood clots). Research is
currently underway to determine how plaques that are prone to rupture
can best be identified before they cause a heart attack.
This is the first device that can help assess the
chemical make-up of coronary artery plaques and help physicians identify
those plaques with lipid cores, which may be of particular concern,
said Daniel Schultz, M.D., director of the Center for Devices and
Radiological Health.
The InfraReDx LipiScan NIR Catheter Imaging System
uses infrared imaging to detect lipid core-containing plaques of
interest and assess a patient's coronary artery lipid core burden index.
The device works by placing a catheter equipped with a fiber-optic laser
light into the artery. The device shines the near infrared light
delivered through the blood to the artery wall, and measures the light
reflected back from the artery wall, a technique called spectroscopy.
The reflected wavelengths vary depending on how much fat and other
substances are in the plaque in the illuminated portion of the wall.
LipiScan is manufactured by InfraReDx Inc. of
Burlington, Mass. The device is cleared for use by physicians who are
evaluating patients with symptoms of coronary heart disease during a
heart test known as cardiac angiography, to help in detection of plaques
that have lipid (fatty) cores.
The company
news releases follows:
FDA Grants Market Clearance for the LipiScan
Coronary Imaging System Developed By InfraReDx, Inc.
A novel spectroscopy system for the identification of
lipid core containing plaques of interest in the coronary arteries
April 29, 2008 Burlington, Massachusetts
InfraReDx, Inc. announced today that it has
received 510(k) clearance from the U.S. Food and Drug Administration
(FDA) to market its catheter-based LipiScan Coronary Imaging System.
The LipiScan device uses near-infrared spectroscopy to identify lipid
core containing plaques of interest in the coronary arteries in patients
already undergoing cardiac catheterization. Such plaques, which cannot
be detected by commonly-used tests such as a treadmill examination and
even coronary angiography, are suspected to be the cause of most sudden
cardiac deaths and non-fatal heart attacks.
The availability of this novel tool culminates a
decade-long biomedical engineering effort to create an instrument that
could perform spectroscopy in the arteries of patients with coronary
artery disease. The identification of the chemical composition of
coronary plaques is expected to be of value to cardiologists in the
selection of medical, stenting or surgical therapy for coronary lesions.
The device is also expected to be of value to the pharmaceutical
industry as a means to assess the effect of novel anti-atherosclerotic
agents on lipid core plaque burden.
"The InfraReDx team is pleased that the LipiScan
System has been validated in tissue samples and a clinical study and has
been cleared by the FDA for use in patients. We understand the great
potential of interventional cardiology and anticipate that this novel
tool will assist physicians with the complex decisions they face in the
management of patients with coronary artery disease, says James E.
Muller, M.D., cardiologist, co-founder, President and CEO of InfraReDx,
Inc.
Dr. Muller noted that the creation of this novel
device was greatly aided by the support and expertise of Sanderling
Ventures of San Mateo, California. Robert McNeil, Ph.D., Chairman of
the Board of InfraReDx, and Timothy Mills, Ph.D., InfraReDx Board member
are managing directors of Sanderling and both have extensive experience
in medical device development, said Dr. Muller. Sanderling was a seed
investor in Advanced Cardiovascular Systems, a company that pioneered
development of balloon angioplasty and was acquired by Guidant.
While angioplasty and stenting were major
advances, stenting has not been capable of preventing heart attacks due
to the difficulty in identifying lesions likely to rupture and cause
thrombosis. With the development of the LipiScan Coronary Imaging
System, Sanderling is again contributing to a major step forward in
providing a useful tool with which interventional cardiologists may
improve the care of cardiac patients.
There is a real unmet medical need to identify
lipid core containing plaques of interest in the coronary arteries,
which before now we could not do, says James Goldstein, M.D., Director
of Research and Education at William Beaumont Hospital in Royal Oak,
Michigan, who is also an investigator in the SPECTACL clinical trial for
the device and a consultant for InfraReDx. The ability to detect lipid
core containing plaques of interest may go a long way in providing
information to help prevent heart attacks in the near future.
How the LipiScan Coronary Imaging System Works
Near-infrared (NIR) spectroscopy is commonly used to measure the
chemical composition of unknown substances. The LipiScan Coronary
Imaging System utilizes advanced optical technology, much of it
developed for telecom uses, to deliver and retrieve NIR light from
coronary plaques. The light reflected back at different wavelengths is
analyzed to detect the chemical composition of the coronary plaques. At
the completion of the catheter pullback, the LipiScan console instantly
displays the scan results on a chemogram, a digital color-coded map of
the location and intensity of lipid core containing plaques of interest
in the artery. A Lipid Core Burden Index is also reported, which is a
measure of the total amount of lipid core containing plaques of interest
in the coronary artery. The LipiScan catheter interrogates each artery
in less than 2 minutes and does not require the interruption of the flow
of blood.
Successful Clinical Trial Results The SPECTACL clinical trial documented the similarity of
near-infrared spectra obtained from 106 patients undergoing coronary
angiography compared to spectra obtained in autopsy specimens in which
the gold-standard of histology was available. For more information,
visit the InfraReDx website at
www.infraredx.com.
About InfraReDx, Inc. InfraReDx, Inc. is a privately-owned medical device company with
expertise in near-infrared (NIR) spectroscopic technology and its
application to coronary imaging. The company, located in Burlington, MA,
was founded in 1998 to meet the unmet medical need for the detection and
identification of lipid core containing plaques of interest in the
coronary arteries. To meet this medical need, the Company developed The
LipiScan Coronary Imaging System, an easy-to-use, catheter-based
coronary imaging system that uses near-infrared spectroscopic technology
to detect and characterize the composition of coronary artery plaques in
patients undergoing catheterization. Funding for the development of the
LipiScan System has been provided by a group of over 80 private
investors and Sanderling Ventures. A Series C Funding round in 2007
raised $17 million. For more information, visit the InfraReDx website at
www.infraredx.com.
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June
17, 2008