InfraReDx device gets FDA nod

U.S. regulators approved the first device that lets doctors see fat buildup inside coronary arteries to gauge heart attack risk.

The LipiScan NIR Catheter Imaging System uses infrared technology to identify when artery-clogging plaque has a large fatty core, a characteristic that has been linked to ruptures and blood clots, according to a statement posted today on the Food and Drug Administration's Web site. The device is made by closely held InfraReDx Inc., of Burlington, Massachusetts.

Almost 1 million Americans have heart attacks each year and about half die, the FDA said. Many heart attacks are caused by ruptures in the fatty calcium and other substances that stick to artery walls, making it hard for blood to pass.

The LipiScan device works by inserting a fiber-optic laser into the artery, shining light through the blood to the artery wall and measuring the wavelengths that are reflected back, the FDA said.
(Bloomberg)