SAN DIEGO, May 18, 2009 /PRNewswire-FirstCall via COMTEX News Network/ -- Volcano Corporation (Nasdaq: VOLC), a leader in the development, manufacturing and sales of products for the diagnosis and treatment of coronary and peripheral artery disease, today announced an exclusive worldwide distribution agreement to initiate the formal launch of the Xtract(TM) thrombus aspiration catheter, manufactured by Lumen Biomedical. The Xtract(TM) thrombus aspiration catheter is available for immediate sale in the U.S. and Europe. This marks Volcano's entry into what we believe is a $70+ million aspiration market.
The Xtract(TM) thrombus aspiration catheter has been cleared by the FDA and is CE marked for use in coronary vessels, as well as some peripheral vascular applications. The device incorporates three unique design attributes that enhance its performance. These include a single lumen design to maximize cross-sectional area, and in turn, thrombus suction; a circular, right angle tip for close-up access to clots; and a curved, directional tip to enable full sweep of the vessel. These unique design features enable physicians to offer a truly new approach for thrombus aspiration.
Scott Huennekens, President and CEO of Volcano, commented, "This distribution agreement with Lumen Biomedical for the Xtract(TM) thrombus aspiration catheter is perfectly aligned with our corporate strategy, and builds on the unique value that Volcano offers to the interventional cardiology community. Volcano does not believe that a one-size-fits-all technology is capable of addressing complex disease states such as AMI, CTO and bifurcations, which continue to challenge clinicians today. Instead, we feel that application-specific tools such as IVUS-guided balloons, forward-looking IVUS catheters and tissue composition technologies can better target and treat the appropriate patient and lesion. Although our core technologies are certainly applicable to less complex patients, our goal at Volcano is to become a leader and trusted advisor for physicians' most challenging cases by providing a tailored product portfolio complete with precision guidance tools and state-of-the-art therapies. The Lumen Xtract(TM) thrombus aspiration catheter now gives us a second generation aspiration catheter to complement our IVUS and VH IVUS imaging tools in these challenging AMI patients. This expansion of our product offerings is very consistent with our multi-modality platform strategy, and the theme of our PCR symposium this week--Treat the right patient and the right lesion, the right way."
Jim Margolis, Director, Cardiovascular Research and Education, Miami International Cardiology Consultants, commented, "We have been using the Xtract catheter at Jackson Memorial Hospital since October 2008. In my view, compared to other thrombectomy catheters I have used, this device is in a generation of its own. It tracks better, removes an order of magnitude more debris, and resists kinking. Because of its ease of use and effectiveness, some of us have begun using it on non-STEMI patients as well as STEMI patients."
Matt Ogle, President and CEO of Lumen Biomedical, commented, "We are thrilled to have Volcano as our exclusive worldwide partner for the distribution of the Xtract(TM) device. We feel that the Xtract(TM) catheter is a best-in-class aspiration device, and can mirror the success that Volcano has had in IVUS which now commands more than 50% of the U.S. imaging market. Lumen Biomedical is excited to leverage the global reach of Volcano's 130 plus direct sales and training professionals in the U.S. and Europe."
Mr. Huennekens continued, "The use of thrombus aspiration in AMI patients has increased dramatically, fueled by the positive one-year results of the TAPAS study, which was published in the New England Journal of Medicine. However, aspiration is only a part of the solution. Our early experience with IVUS and VH IVUS in AMI patients suggests that the site of the minimum lumen diameter as seen by angiography is often not at the site of the suspected plaque rupture, but may instead be a downstream aggregation of thrombotic debris. Repeated case examples have demonstrated that the true culprit of the culprit lesion is often found upstream of the angiographic blockage, suggesting that angiographic guidance alone is often inadequate, and may be misleading. With more precise imaging, and a more complete portfolio of lesion specific tools, Volcano is on our way toward positioning ourselves as an important AMI resource in the cath lab."
Volcano is hosting an evening symposium at this year's PCR congress titled "What matters more in PCI: the type of DES you use... or optimizing acute procedural outcomes?" The objective of this program is to outline how IVUS, VH(R) IVUS and fractional flow reserve (FFR) can optimize acute procedural outcomes in acute coronary syndrome as well as elective patient populations and is chaired by Prof. M. Rothman. Speakers include; Dr. J.M. de la Torre Hernandez, Prof. Dr. med M. Haude, Dr. D. Dudek, and Dr. B. de Bruyne. The symposium will be held on Thursday May 21st, from 17:00 - 18:30 in room 3 at the Forum CCIB Convention Center in Barcelona, Spain. Please visit the Volcano booth B02 for more information on the symposium, multiple live case transmissions, product demonstrations or hands-on FFR, IVUS and OCT education.
Volcano Corporation (Nasdaq: VOLC) 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 phased array and rotational IVUS imaging catheters, and advanced functionality options, such as VH(R) IVUS tissue characterization and ChromaFlo(R). 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) and Forward Looking IVUS systems and catheters. Currently, more than 4,200 Volcano IVUS and FM systems are installed worldwide, with approximately half of its revenues coming from outside the United States. Volcano also develops and manufactures optical monitors, lasers and optical engines used in OCT imaging systems and advanced photonic components and subsystems used in spectroscopy and other industrial applications. For more information, visit the company's website at http://www.volcanocorp.com.
Forward Looking Statements
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 features, functionality and potential benefits of our products and patient outcomes, the market potential of the XtractTM catheter acceptance and adoption of the company's technology and growth and market development. 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 were made, or to reflect the occurrence of unanticipated events.
SOURCE Volcano Corporation
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