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InfraReDx, Inc. announced that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) to market the LipiScan IVUS Coronary Imaging System.

LipiScan IVUS is the first cardiac catheter to combine intravascular ultrasound (IVUS) and near-infrared (NIR) spectroscopy to help cardiologists identify and characterize the plaques that complicate stenting and are associated with acute coronary events.

The NIR spectroscopy identifies the chemical content of the plaques; the IVUS provides an image of plaque structure and stent features. The Company expects to conduct a broad commercial launch of the system within the U.S. by year-end 2010, and anticipates regulatory approval and launch in Europe during 2011.

InfraReDx's first-generation LipiScan NIR system is already in use at approximately 25 cardiac centers in the U.S. and is the only FDA-cleared device for the detection of lipid core coronary plaques (LCP). LCP is a fatty coronary artery plaque known to complicate stenting and suspected to cause most heart attacks following stenting. The addition of IVUS imaging enhances the value of LipiScan by providing visualization of the coronary artery lumen, assessment of the structural features of coronary plaque, and identification of proper stent sizing and expansion. The LipiScan IVUS system's innovative design provides physicians with a grayscale IVUS image of the coronary artery along with a complete and co-registered chemogram  a map of LCP within the imaged vessel.

Carefully designed to meet the workflow demands of today?s busy interventional catheterization labs, the LipiScan IVUS system is able to generate and display the combined chemogram/IVUS analysis immediately upon completion of the single catheter pullback. The LipiScan IVUS system provides physicians with an unparalleled ?one-stop? visual determination of critical coronary features that will assist in care of coronary patients, including identification of lipid-core plaques, degree of stenosis, reference vessel diameter, plaque burden and stent expansion and apposition.

"We are pleased to have achieved the important milestone of FDA marketing clearance for LipiScan IVUS, our multi-modality, single-catheter device that provides improved characterization of coronary plaques," said James E. Muller, M.D., founder and chief executive officer at InfraReDx. "Interventional cardiologists adopting the LipiScan IVUS system will be able to quickly and accurately identify the presence and structural features of lipid-core plaques in the coronary arteries. Such knowledge will assist them in the conduct of the stenting procedure and provide information useful in the treatment of patients post-stenting. We look forward to making LipiScan IVUS available to cardiac catheterization laboratories in the United States within the next six months, and throughout the world in the following years."

Source: InfraReDx, Inc.