InfraReDx nets FDA 510(k) clearance for coronary imaging system

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The FDA has approved the sale of a new laser scanning system developed by InfraReDx, intended to locate fatty deposits in blood vessel walls that are believed to cause heart attacks.

Burlington, Mass.-based InfraReDx said that it expects that the system will help doctors avoid placing coronary stents in vessels in ways that might raise the risk of a heart attack.

InfraReDx said its catheter, which emits near-infrared laser light inside the artery and forms an image from how much is absorbed, could produce a fuller picture of the contents and dimensions of lipids in the vessel walls.

The system has a computer console that analyzes and displays the data gathered by the LipiScan laser catheter, which costs $2,400 and can be used only once, said InfraReDx.

No insurers yet cover the procedure, the company reported.