The U.S. Food and Drug Administration has cleared for marketing 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.
Nearly one million Americans suffer a heart attack every year and
about half die. 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.
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April 29, 2008
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Media
Inquiries:
Karen Riley, 301-827-6244
Consumer Inquiries:
888-INFO-FDA
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