The Food & Drug Administration gave InfraReDx Inc. 510(k) clearance for the company’s LipiScan IVUS coronary imaging system.
The device employs both so-called "near-infrared" spectroscopy and intravascular ultrasound technology to give cardiologists a grayscale IVUS image of a coronary artery, along with a map of lipid core coronary plaques within a blood vessel.
The data enables cardiologists to both visualize coronary plaques to guide stent placement and determine whether the build-ups are comprised of the fatty plaques that complicate stenting procedures and patients’ recovery, according to a press release.
The company said LipiScan IVUS is the first and only FDA cleared product to pair NIR spectroscopy and IVUS technology into one system.
Burlington, Mass.-based InfraReDx is planning its commercial launch of the imaging system in the U.S. later this year and is hoping for CE Mark approval in Europe in 2011. The company currently sells the LipiScan NIR system and the device is in use at approximately 25 cardiac centers in the U.S.