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140 million cycles reached, with excellent results compared to the commercially available bioprosthesis 'control', and more than half way to U.S. regulatory requirement of 200 million cycles, expected to be reached by year's end
Successful mechanical testing is a critical step in the certification of CoreValve's ReValving™ approach to percutaneous aortic valve replacement (PAVR) as a future alternative to open-heart surgery
IRVINE, Calif., and PARIS, Oct. 5, 2005—CoreValve (www.corevalve.com) announced today that it has reached 140 million cycles in its accelerated cycling protocol related to the Company's proprietary porcine pericardium aortic heart valve for its ReValving™ System for percutaneous aortic valve replacement (PAVR).
"Our purpose, of course, is to demonstrate that CoreValve's proprietary aortic heart valve, which was specifically designed to be deployed percutaneously, is lasting at least as long as currently used tissue valves by surgeons. Actually, our initial findings are that our valve behaves, in vitro, even better," said Jacques Séguin, M.D., Ph.D., Chairman, CEO and Founder of CoreValve. "In vitro accelerated fatigue testing—that is, compressing the effects of years of service life into months of testing—is an accepted and reliable methodology for quantifying a prosthetic heart valve's durability. Advanced control and data acquisition methods are used to monitor valve function and integrity, and the Company is conducting this testing under strictly controlled regulatory guidelines."
"We are very pleased with our testing program's progress to date," added Rob Michiels, President of CoreValve USA, "and we fully expect to satisfactorily conclude all mechanical testing protocols in the next quarters. CoreValve remains on schedule to commence its definitive international pivotal trial to seek a CE Mark and marketing approval in Europe."
"The third phase of our ongoing Feasibility Study—in frail, high-surgical-risk patients using our own heart valve design and delivered by our smaller, 21-French-sized catheter—has dramatically eased implantation and reduced the ReValving procedure time," added Dr. Séguin. "The fact that our second-generation delivery catheter has now been reduced in size to 21-French makes maneuverability and general handling of this new catheter design much superior to firstgeneration devices. When considering the durability and physiologic characteristics of our prosthesis, combined with its 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."
About CoreValve
Founded in 2001, privately held CoreValve—which is headquartered in Paris and has R&D and manufacturing facilities in Irvine, California—has developed a proprietary delivery system for percutaneous heart valve replacement, based on a novel catheter-and-self-expanding-frame approach on a beating heart, thus avoiding open-heart surgery. The CoreValve procedure—with the proprietary CoreValve Percutaneous ReValving System™—can 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.
This news release contains certain "forward-looking" statements under the Private Securities Litigation Reform Act 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 industry and the economy and other factors.
Contact: Ronald Trahan, APR, Ronald Trahan Associates Inc., 781-762-9782, x18
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