The News

Corevalve's revalving™ system demonstrated 'live' at opening session of TCT 2005 to an audience of 12,000 interventional cardiologists and device industry executives

20/10/2005

ReValving™ was used instead of open-heart surgeryto non-surgically implant a new aortic bioprosthesis over the diseased heart valve

“The fact that we were willing to show a ‘live’ ReValving procedure to thousands of interventional cardiologists and business development executives at TCT 2005 sends a very strong message that we passionately believe ReValving is the next frontier in interventional cardiology.”
Jacques Séguin, M.D., Ph.D. Chairman, CEO and Founder, CoreValve

IRVINE, Calif., and PARIS, Oct. 17, 2005—CoreValve announced today that its second-generation, proprietary aortic heart valve was implanted successfully — non-surgically — in a ‘high-risk’ patient using CoreValve’s percutaneous ReValving™ System, during the opening session at the Cardiovascular Research Foundation’s (CRF) Seventeenth Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, in Washington, D.C. Eberhard Grube, M.D., chief of cardiology at The Heart Center, Siegburg, Germany, and a consulting professor of medicine at Stanford University, and Jean-Claude Laborde, M.D., an interventional cardiologist at Clinique Pasteur in Toulouse, France, performed the ReValving procedure in the “cath lab” at The Heart Center. As a result, their patient was able to avoid open-heart surgery to treat a defective aortic heart valve.

CoreValve’s ReValving™ procedure was performed today, ‘live’, via satellite television, for some 12,000 attendees at TCT 2005. This event represents the first-ever successful retrograde “live” percutaneous replacement of an aortic heart valve to an audience comprised of interventional cardiologists and industry business development executives in attendance at TCT. The Cardiovascular Research Foundation is the sponsor of the Annual Transcatheter Cardiovascular Therapeutics scientific symposium, one of the largest interventional vascular medicine meetings in the world.

“It is now dramatically obvious to literally thousands of interventional cardiologists around the world that CoreValve’s ReValving System has enormous potential to nonsurgically treat aortic valve disease,” said Jacques Séguin, M.D., Ph.D., Founder, Chairman and CEO of CoreValve. “Today’s successful ‘live’ ReValving procedure, which is part of our feasibility clinical trials and which, combined with the excellent results of our previous 20 cases, bears strong witness that ReValving will have a place in the future of interventional cardiology.”

Of special note: The ‘live’ ReValving™ procedure at TCT used CoreValve’s own proprietary porcine pericardium aortic heart valve, delivered via CoreValve’s small 21- French-sized catheter, and required less than 15 minutes to be implanted.

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 catheterand- 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. 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.