July 14, 2008
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FDA OKs infared imaging device for plaque assessment

The FDA has approved a plaque imaging system that uses an infrared scanning device to assess plaque structure.

The device has been cleared for use in patients with symptoms of coronary heart disease during cardiac angiography, according to a press release.

The InfraReDx LipiScan NIR Catheter Imaging System, manufactured by InfraReDx Inc., detects plaque within coronary artery walls by using an infrared imaging device. The device is placed at the end of a catheter equipped with a fiber-optic, high-powered laser. The device shines the light onto the artery walls and uses spectroscopy to image the plaques within the walls. The characterization of the lipid-core plaques is then used to assess the patient's coronary artery lipid burden.

"This is the first device that can help assess the chemical makeup of coronary artery plaques and can help physicians identify those plaques with lipid cores, which may be of particular concern," Daniel Schultz, MD, director of the Center for Devices and Radiological Health, said in the press release. — by Eric Raible