InfraReDx receives 510(k) clearance to market LipiScan IVUS Coronary Imaging System

InfraReDx, Inc., a medical device company developing intelligent cardiovascular diagnostic imaging technologies, today 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."

James Goldstein, M.D., director of Cardiac Research and Education for the William Beaumont Hospital in Michigan, stated, "The LipiScan IVUS System significantly advances the field of intracoronary imaging. We are eager to bring the system to the William Beaumont hospital, where we are already successfully employing the LipiScan NIR system and gleaning key insights from the chemogram information it provides. The inclusion of plaque structure data via LipiScan IVUS further elevates the system's practical clinical utility for characterizing coronary lesions and identifying lipid core plaque. This information can better inform technique and treatment decisions for my patients today, and, in the future, holds the promise to help prevent heart attacks and sudden death." Dr. Goldstein has been involved in vulnerable plaque-related research for more than 10 years, and currently serves as a consultant to InfraReDx as well as other medical device and imaging technology companies.

David Rizik, M.D., medical director of Invasive Cardiology at Scottsdale Healthcare Shea Medical Center, commented, "Patients are increasingly presenting to the cath lab with complex lesions, such as left main disease, multi-vessel disease and bifurcation lesions. In these patients, angioplasty guided by angiography alone is inadequate to prevent potential complications such as restenosis, stent thrombosis, and peri-procedural myocardial infarction." He continued, "To address these challenging cases, we have already incorporated the use of the original LipiScan system to help us identify lipid core plaques that complicate stenting. We are excited to acquire the next-generation LipiScan IVUS, as the addition of IVUS technology to the LipiScan platform will transform this novel diagnostic tool into a truly indispensible component of our lab."  

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 recognizing the limitations of relying on angiography alone and are turning to advanced imaging solution systems to optimize stenting strategy.