The News

100th patient successfully treated using Corevalve's Revalving™ device to non-surgically replace a diseased aortic heart valve

21/11/2006

Third-generation, 18-French-sized ReValving System, with greater ease of implantation and suitability for wider number of patients, is being adopted quickly by interventional cardiologists who are participating in the ongoing international clinical trial of ReValving

“This 100th successful case represents a momentous occasion for CoreValve when one considers that there have been no device-related deaths and no device failures during implantation and at up to 22 months of follow-up to date. But what should not be overlooked is that all these patients would have otherwise been left untreated, many of them facing imminent death, because they were too frail for the only other treatment alternative: open-heart surgery.”
Jacques Séguin, MD, PhD, Chairman, CEO and Founder, CoreValve

IRVINE, Calif., Nov. 21, 2006—CoreValve announced today that a total of 100 patients at nine worldwide investigative sites have now undergone percutaneous aortic valve replacement (PAVR) on a beating heart with the CoreValve Percutaneous ReValving™ System to treat either their aortic stenosis, aortic regurgitation, or failed-tissue-valve-prosthesis conditions.

“It is important to note that these patients are able to realize a substantially improved quality-of-life at follow-up now out to nearly two years in some cases,” said Jacques Séguin, M.D., Ph.D., Chairman, CEO and Founder of CoreValve. “The 100th ReValving patient also represents the 21st patient who has undergone the ReValving procedure with our third-generation device, and the ease of implantation of the 18-French delivery catheter is fast-forwarding adoption by the interventionalists who participate in the ongoing clinical trial of ReValving. Because the reduced-size delivery catheter allows access in patients with smaller or more diseased arteries, a much wider range of patients can undergo the ReValving procedure—all high-risk patients who are contraindicated for the only other active-treatment alternative: open-heart surgery.”

Added Rob Michiels, President and Chief Operating Officer of CoreValve: “In light of our recent announcements about the 18-French ReValving procedure being performed not only in a purely percutaneous manner (no surgical cut-down) but also without the use of extracorporeal bypass, other cardiac assistance or even rapid pacing, our clinical investigators are rapidly moving ReValving toward a less complex and nearly standard cath lab procedure. These technical and clinical achievements bolster our belief that ReValving is positioned to become an alternative to open-heart surgery in the future.”

Founded in 2001, privately held CoreValve—which is headquartered 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.

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. Non-USA clinical investigations are in progress. Not available for sale.)