The European Union has granted InfraReDx’s LipiScan IVUS Coronary Imaging System a nod of approval for its marketing throughout Europe.
The CE mark makes the LipiScan the only intravascular ultrasound system (IVUS) approved in both Europe and the U.S. The device is used to detect plaque prior to and during stenting and combines both IVUS and near-infrared spectroscopy to help cardiologists characterize complicated plaque.
The LipiScan system was approved in the U.S. in June 2010 and is the only FDA device cleared to detect lipid core coronary plaques. The system can characterize both the composition and structure—degree of stenosis, vessel diameter and plaque burden—of intracoronary plaque and can aid with stent placement.
Lastly, the system can produce a Chemogram map that indicates the location of lipid core plaques and identifies plaque burden, Burlington, Mass.-based InfraReDx noted.