CoreValve's Third-Generation, 18-French ReValving(TM) System for Non-Surgical Replacement of Defective Aortic Heart Valves Reaches "Durability Testing" Completion.200 Million Cycles Reached with Excellent Results Compared to the Commercially Available, Surgical-Type Bioprosthesis 'Control'; Successful Mechanical Testing is a Critical Step in the Certification of CoreValve's ReValving[TM] Approach to Percutaneous Aortic Valve Replacement In percutaneous aortic valve replacement (PAVR), a synthetic valve is transported to the heart through a small hole made in groin. This procedure can be compared to that performed when placing a stent, or performing balloon angioplasty. (PAVR) as a Future Alternative to Open-Heart Surgery IRVINE, Calif. -- CoreValve (www.corevalve.com) announced today that it has reached 200 million cycles in its accelerated cycling protocol related to the Company's proprietary porcine porcine /por·cine/ (por´sin) pertaining to swine. porcine pertaining to pig. See also hog (1), swine. porcine circovirus 1 a nonpathogenic virus. pericardium pericardium: see heart. aortic aortic pertaining to or emanating from the aorta. See also aortic arch. aortic aneurysm occurs most often in dogs, where it is caused by Spirocerca lupi larvae, turkeys and primates, causing dyspnea, cyanosis and coughing. heart valve for its ReValving[TM] System for percutaneous aortic valve replacement (PAVR). "The purpose of this testing was to demonstrate that CoreValve's proprietary aortic heart valve, which is specifically designed to be deployed percutaneously, can last at least as long as tissue valves currently used by cardiovascular surgeons. Actually, our initial findings are that our valve behaves, in vitro in vitro /in vi·tro/ (in ve´tro) [L.] within a glass; observable in a test tube; in an artificial environment. in vi·tro adj. In an artificial environment outside a living organism. , even better," said Jacques SE[umlaut umlaut ( m`lout) [Ger.,=transformed sound], in inflection, variation of vowels of the type of English man to men. ]guin, M.D., Ph.D., Chairman, CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. and Founder of CoreValve. "In vitro accelerated fatigue testingCothat is, compressing the effects of years of service life into months of testingCois an accepted and reliable methodology for quantifying a prosthetic pros·thet·ic adj. 1. Serving as or relating to a prosthesis. 2. Of or relating to prosthetics. prosthetic serving as a substitute; pertaining to prostheses or to prosthetics. heart valve's durability. Advanced control and data-acquisition methods were used to monitor valve function and integrity, and the Company conducted this testing under strictly controlled regulatory guidelines," added Rob Michiels, President and COO of CoreValve. "This event represents another mission-critical milestone toward marketing clearance in Europe as well as commencement of clinical trials in the United States." "Additional safety and efficacy clinical trials are underway, and we expect to clearly demonstrate that our ReValving technology fulfills the promise of a truly percutaneous procedure performed by the interventional cardiologist in the cath lab," added Dr. SE[umlaut]guin. "The fact that the delivery catheter has now been reduced in size to 18-French makes maneuverability and general handling of this new catheter design much superior to previous-generation devices. When considering the durability and physiologic characteristics of our bioprosthesis, combined with the procedural ease of implantation, there can be no doubt that these technical and clinical achievements have established CoreValve as the undisputed leader in percutaneous aortic valve replacement (PAVR)." About CoreValve Founded in 2001, privately held CoreValveCowhich is headquartered in Paris and has R&D and manufacturing facilities in Irvine, CaliforniaCohas developed a proprietary delivery system for percutaneous heart valve replacement Heart Valve Replacement Definition Heart valve replacement is a surgical procedure during which surgeons remove a damaged valve from the heart and substitute a healthy one. , based on a novel catheter-and-self-expanding-frame approach on a beating heart, thus avoiding open-heart surgery. The CoreValve procedureCowith the proprietary CoreValve Percutaneous ReValving System[TM]Cocan be performed in a cardiac "cath lab" just like angioplasty and stenting, resulting in less trauma to the patient and substantial cost-savings to the healthcare system. For more information about CoreValve, visit the Company's Web site at www.corevalve.com. Forward-Looking Statements This news release contains certain "forward-looking" statements under the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. These "forward-looking" statements, which may include, but are not limited to, statements concerning the projections, financial condition, results of operations and businesses of CoreValve, are based on management's current expectations and estimates and involve risks and uncertainties that could cause actual results or outcomes to differ materially from those contemplated by the forward-looking statements. Factors that could cause or contribute to such differences may include, but are not limited to, risks relating to the protection of intellectual property, changes to governmental regulation of medical devices, the FDA's approval of new products, the impact of competitive products, changes to the competitive environment, the acceptance of new products in the market, conditions of the interventional cardiology interventional cardiology Cardiology The subspecialty of cardiology dedicated to the diagnosis, medical and mechanical therapy, pre- and post-procedure management of adult patients with acute and chronic forms of cardiovascular disease amenable to catheter-based industry and the economy and other factors. (Caution: the CoreValve ReValving[TM] System will not be available in the USA for clinical trials or for commercialization until further notice.) |
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