Volcano Corporation (Nasdaq: VOLC), 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 today that it 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," commented 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."