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CoreValve completes enrollment of its ‘second-generation 21-French’ ReValving™ system international clinical trial for non-surgical replacement of the diseased aortic heart valve of patients not eligible for open-heart surgery

Publiée le 28/06/2006

“After treating more than 50 patients with the second-generation ReValving system, we are now  awaiting clinical follow-up and are immediately moving forward with the clinical trial of our  third-generation 18-French ReValving system.”
Jacques Séguin, MD, PhD, Chairman, CEO and Founder, CoreValve

IRVINE, Calif., and PARIS, June 28, 2006—CoreValve  announced today that it has completed minimal enrollment in a clinical trial involving its second-generation CoreValve Percutaneous ReValving™ System.  Fifty-one patients at seven investigative sites in Europe and North America have now successfully undergone percutaneous aortic valve replacement (PAVR) with the ‘second-generation, 21-French’ ReValving™ system to treat either aortic stenosis, aortic regurgitation, or failed-tissue-valve-prosthesis conditions. Each of these patients was at very high risk for open-heart surgery.  CoreValve expects to use the results of this trial as part of a future CE Mark submission seeking approval to market the ReValving system in the European Union.

“We have developed a breakthrough system for replacing an aortic valve via a peripheral, intravascular, percutaneous approach—on a beating heart. The result is that one hundred percent of the patients discharged from various hospitals involved in our second-generation clinical trial continue to show improved cardiac function with no complications, while enjoying a dramatically enhanced quality-of-life at follow-up now out to 17 months in some cases,” said Jacques Séguin, M.D., Ph.D., Chairman, CEO and Founder of CoreValve. “We are therefore confident that the results of this study, when completed, will be part of the strong foundation for a CE Mark submission.”

Added Rob Michiels, President and Chief Operating Officer of CoreValve: “This trial has dramatically underscored the significant benefits of our second-generation, 21-French-sized system compared to the first-generation, 25-French system. No doubt, the smaller catheter greatly improves the ease of the ReValving procedure, and our investigators are now routinely accessing, delivering and placing our porcine pericardial-tissue bioprosthesis in less than 15 minutes. While we are extremely pleased with these clinical results, we are nonetheless moving immediately toward another clinical trial using our third-generation system, whose delivery catheter has been downsized to 18-French. This further reduction in size is particularly important to the interventional cardiologist when accessing a diseased aortic valve via calcified and tortuous vessels. We fully expect our 18-French system will also make alternative access through the subclavian arteries feasible.  These technical milestones and clinical outcomes continue to clearly position CoreValve as the indisputable frontrunner in percutaneous aortic valve replacement.”

About CoreValve
Privately held CoreValve, with U.S. headquarters in Irvine, Calif., 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. 

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™ System will not be available in the USA for clinical trials or for commercialization until further notice.