FDA Clearance for Eagle Eye Platinum

Volcano Corporation, a leading developer and manufacturer of precision intravascular therapy guidance tools designed to enhance the diagnosis and treatment of coronary and peripheral vascular disease, announced that is has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the Eagle Eye Platinum digital IVUS catheter in the United States. This state-of-the-art catheter offers all of the benefits of the predecessor Eagle Eye Gold catheter, plus improved deliverability and the convenience of additional radiopaque markers. Commercial release of Eagle Eye Platinum in the U.S. is expected in the second quarter of 2010.

"Multiple studies have shown the benefits of IVUS imaging," comments Scott Huennekens, president and chief executive officer of Volcano. "With Eagle Eye Platinum, we're now providing clinicians further improvements to our industry-leading catheter design. Despite the fact that our customers have made Eagle Eye Gold the #1 selling IVUS catheter in the United States, we recognize the need to continuously improve our products to support the treatment of the increasingly challenging blockages or lesions interventional cardiologists are addressing. Our investments in advanced catheter design have resulted in the Eagle Eye Platinum, a product that has enhanced deliverability, is significantly easier to use, and includes Volcano's proprietary VH IVUS tissue characterization technology, a unique imaging modality that is backed by 15 years of research and data published in over 100 articles, and has been studied in over 10,000 patients."

Vince Burgess, Group President for Advanced Imaging Systems, remarked, "Clinical data continues to illustrate that angiography alone is often not enough to properly assess and treat coronary lesions. The STLLR (The Impact of Stent Deployment Techniques on Clinical Outcomes on Patients Treated with the Cypher Stent) trial was a double-blinded clinical study that showed that geographic miss, which means improperly covering the length of a lesion or vessel blockage, is a contributing factor to poor stenting outcomes, stent thrombosis, and an increased risk of clinical events. In STLLR, where interventions were guided by angiography alone, optimal placement of the stent was achieved in only about half of the procedures. The addition of marker bands is also significant. Although IVUS has been the gold standard for objective measurements of lumen size, plaque composition, and stent expansion, many regular IVUS users still do not use IVUS to make lesion length assessments. Eagle Eye Platinum's radiopaque markers should provide a quick and easy way for physicians to estimate lengths without the need for a separate pullback device. We believe that this new feature along with the deliverability improvements will increase usage among physicians, allowing for more precision and accuracy in treating blood vessel blockages."

The Eagle Eye Platinum is the third generation of catheters in the Eagle Eye product line. To date, Eagle Eye catheters have been used in over 500,000 procedures worldwide. Like Eagle Eye Gold, the Eagle Eye Platinum catheter offers fast, plug-and-play functionality as well as grayscale IVUS, VH IVUS, and ChromaFlo imaging modalities.