InfraReDx LipiScan IVUS Coronary Imaging System Receives CE Mark Approval

April 20, 2011—InfraReDx, Inc. (Burlington, MA) announced that it has received CE Mark approval to begin commercialization of the LipiScan intravenous ultrasound (IVUS) coronary imaging system in Europe. The device is also available in the United States, where it received US Food and Drug Administration (FDA) approval in June 2010. 

According to InfraReDx, the system includes a cardiac catheter to combine IVUS and near-infrared (NIR) spectroscopy to help identify and characterize lipid core coronary plaques. A single catheter pullback provides a traditional IVUS image that displays key structural parameters of the lesion, including its location, length, and degree of stenosis, in addition to confirming proper stent placement. The system concurrently performs spectroscopic analysis of optical data to produce a chemogram map that indicates the location of lipid core plaques and quantifies their lipid core burden. Integrating and coregistering the chemogram with IVUS provides critical information to interventional cardiologists during the cardiac catheterization procedure, the company stated.

“The LipiScan IVUS system is an important new intravascular imaging tool that will be of immediate value to interventional cardiologists for the diagnosis and management of their patients,” commented Professor Patrick W. Serruys, MD, of the Thoraxcenter of Erasmus University Hospital in Rotterdam, The Netherlands. “This impressive multimodality system provides an IVUS image of the vessel while simultaneously performing spectroscopic analysis for the accurate and immediate detection of lipid core plaques demonstrated to complicate stenting and suspected to cause most heart attacks. The Thoraxcenter is proud of its association with InfraReDx and the role we have played in the development of the LipiScan IVUS system and imaging catheter."