Ten-year-old InfraReDx of Burlington, MA, has gotten clearance from the FDA to market a catheter-based tool that lets doctors peer into the plaques on the walls of coronary arteries and determine which ones have lipid cores. Such fatty plaques may be more prone to rupture and form blood clots, a common cause of heart attacks, according to an FDA press release.
“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 the director of the agency’s director of Center for Devices and Radiological Health, Daniel Schultz, in the announcement. The so-called LipiScan Coronary Imaging System does this by lighting up the artery’s interior with near-infrared light from a fiber-optic laser and measuring the wavelengths that are reflected back. Much of the optical technology involved was originally developed for telecom uses, according to InfraReDx. The FDA has approved the device for use in patients who are already undergoing a standard catheter-based procedure called cardiac angiography.
In an article about the FDA’s clearance of the device, the New York Times‘ Barnaby J. Feder highlights researchers’ disagreement over the medical significance of the lipid deposits that InfraReDx’s system is designed to detect. While some believe that knowing where these “lipid pools” are will help doctors do a better job of positioning artery-propping stents and choosing the right type of stent for the job, he writes, others “say the whole concept of trying to find and treat lipid pools with devices is a waste of time and money. The pools, they say, are a symptom of arterial disease that affects all of the heart’s arteries and indeed the whole circulatory system.”
No insurers yet cover the use of the LipiScan system, Feder writers; its console costs $150,000 and its single-use catheters cost $2,400 apiece.
More than 80 private investors and Sanderling Ventures have supported the development of LipiScan system, according to InfraReDx.