Volcano Receives FDA Clearance to Market the Eagle Eye(R) Platinum Digital IVUS Catheter
SAN DIEGO, Feb. 9 /PRNewswire-FirstCall/ -- 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."
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.
About Volcano Corporation
Volcano Corporation offers a broad suite of devices designed to facilitate endovascular procedures, enhance the diagnosis of vascular and structural heart disease and guide optimal therapies. The company's intravascular ultrasound (IVUS) product line includes ultrasound consoles that can be integrated directly into virtually any modern cath lab. Volcano IVUS offers unique features, including both single-use digital and rotational IVUS imaging catheters, and advanced functionality options, such as VH® IVUS tissue characterization and ChromaFlo®. Volcano also provides functional measurement (FM) consoles and single-use pressure and flow guide wires and is developing a line of ultra-high resolution Optical Coherence Tomography (OCT) systems and catheters. Currently, more than 4,700 Volcano IVUS and FM systems are installed worldwide, and more than half of Volcano's revenues are derived from outside the United States. Volcano's wholly-owned subsidiary, Axsun Technologies, develops and manufactures optical monitors, lasers and optical engines used in telecommunications, medical imaging, spectroscopy and other industrial applications. For more information, visit the company's website at www.volcanocorp.com.
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release regarding Volcano's business that are not historical facts may be considered "forward-looking statements," including statements regarding the potential benefits of the products and procedures described above, results and implications of the data from the STLLR trial, commercial release and market adoption of the company's technology, and the impact of clinical and other technical data. Forward-looking statements are based on management's current preliminary expectations and are subject to risks and uncertainties which may cause Volcano's results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ from the results predicted are detailed in the company's annual report on Form 10-K, quarterly reports on Form 10-Q and other filings made with the Securities and Exchange Commission. Undue reliance should not be placed on forward-looking statements which speak only as of the date they are made. Volcano undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.
SOURCE Volcano Corporation