InfraReDx, Inc. announces that it has received 510(k) clearance from the US FDA to market the LipiScan IVUS Coronary Imaging System. LipiScan is the first cardiac catheter to combine intravascular ultrasound (IVUS) and near-infrared (NIR) spectroscopy to help cardiologists identify and characterise 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 US 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 centres in the US and is the only FDA cleared device for the detection of lipid core coronary plaques (LCP). The addition of IVUS imaging enhances the value of LipiScan by providing visualisation 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 greyscale IVUS image of the coronary artery along with a complete and co-registered chemogram.
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.
“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” (James E. Muller, M.D., founder and chief executive officer at InfraReDx).
Each year, more than 2 million individuals worldwide undergo coronary stenting. While clinical results of stenting procedures have steadily improved, approximately 30% of individuals undergoing stenting experience a significant adverse event such as peri-stenting myocardial infarction, post-procedure complications from the stented site, or new coronary events at non-stented sites. In most cases, stenting is guided primarily by X-ray angiography, which does not reveal the health of the vessel wall. Increasingly, physicians are recognising the limitations of relying on angiography alone and are turning to advanced imaging solution systems to optimise stenting strategy.