Healthcare Industry News: ReValving
News Release - December 6, 2006
CoreValve announces that its 18-French ReValving(TM) Phase III international clinical trial is now one-third enrolled since commencing less than three months ago
"The size-related ease of use of our 18-French ReValving system for non-surgically replacing a diseased aortic heart valve is driving rapid enrollment of this safety and efficacy study."- Jacques Seguin, M.D., Ph.D., Chairman, CEO and Founder of CoreValve
IRVINE, Calif.--(HSMN NewsFeed)--CoreValve (www.corevalve.com) announced today that it has successfully completed one-third of the enrollment related to a phase III international clinical trial using its patented ReValving System. The Company's system, consisting of a breakthrough 18-French-sized delivery catheter, has now been used successfully to percutaneously implant its proprietary porcine pericardial-tissue bioprosthesis over the diseased aortic heart valves of more than 30 patients in a "cath" lab setting. The safety-and-efficacy clinical trial is expected to enroll 100 patients or more at 12 sites in Europe and Canada.
Of note: the most recent ReValving cases in this ongoing clinical trial have been performed without the use of extracorporeal bypass, other cardiac assistance or even rapid pacing. These truly percutaneous procedures took routine interventional times to complete and, in spite of their high-risk status, patients were released from the ICU within hours of valve implantation and discharged from the hospital within days.
"Accomplishing percutaneous replacement of an aortic heart valve in a cath lab setting, in about 10 minutes excluding prep time, without any assistance whatsoever to the beating heart, is why ReValving has such incredible potential for non-surgically treating the thousands of patients who have diseased aortic heart valves but who are just too fragile to undergo open-chest surgery," said Jacques Seguin, M.D., Ph.D., Chairman, CEO and Founder of CoreValve. "The procedural progress made by the clinical investigators since our much smaller, third-generation ReValving System became available is truly astonishing. From my perspective as a cardiac surgeon, I see the ReValving procedure as a real alternative to surgical aortic valve replacement."
Added Rob Michiels, President and Chief Operating Officer: "We are seeing a ramp-up in enrollment thanks both to the size reduction of the catheter, which allows treatment of patients with smaller access vessels, and to the simplification of the procedure itself. Eliminating the need for cut-down and cardiac assistance positions the ReValving procedure at a level of difficulty not dissimilar to complex percutaneous coronary interventions. We are on schedule to earn CE Mark approval during 2007 and are targeting first-to-market status for our ReValving System in Europe."
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(TM)--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.
Forward-Looking Statements
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.
(Caution: the CoreValve ReValving(TM) System will not be available in the USA for clinical trials or for commercialization until further notice.)
Source: CoreValve
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