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FDA Clears Coronary Plaque Imaging Device

By measuring the lipid content of plaques, device may be able to identify plaques prone to rupture

TUESDAY, April 29 (HealthDay News) -- The U.S. Food and Drug Administration announced Tuesday that it has cleared for marketing a device that physicians can use during cardiac angiography to assess the fat content of atherosclerotic plaques on coronary arteries.

The InfraReDx LipiScan NIR Catheter Imaging System uses infrared technology and spectroscopy to identify lipid-containing plaques of interest and assess the patient's lipid core burden index. A catheter equipped with a fiber-optic laser light is advanced into a coronary artery during cardiac angiography, and the wavelengths of light reflected back from the artery wall are used to calculate the lipid content of plaques lining the vessel.

Because the majority of heart attacks are triggered by the rupture of a vulnerable plaque, the identification of plaques prone to rupture is of great interest. Pathologic studies of patients with fatal heart attacks indicate that plaques with large lipid cores are particularly associated with rupture and thrombosis, and therefore identification of fatty plaques may be important for heart attack prevention.

"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," commented Daniel Schultz, M.D., director of the FDA's Center for Devices and Radiological Health.

LipiScan is manufactured by InfraReDx of Burlington, Mass.

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