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Corevalve's 18-french revalving™ system demonstrated 'live' at TCT 2006

Publiée le 24/10/2006

The percutaneous ReValving™ procedure was used to non-surgically implant a new aortic bioprosthesis over the diseased heart valve of an 88-year-old female patient who was too high-risk to undergo open-heart surgery

IRVINE, Calif., Oct. 24, 2005—CoreValve announced today that its third-generation, proprietary aortic heart valve was implanted successfully — nonsurgically — in a ‘high-risk’ patient using CoreValve’s percutaneous, 18-French ReValving™ System, at the 18th annual ‘Transcatheter Cardiovascular Therapeutics’ (TCT) scientific symposium sponsored by the Cardiovascular Research Foundation (CRF). TCT is one of the largest interventional vascular medicine meetings in the world.

Dr. Eberhard Grube and Dr. Ulrich Gerckens of the HELIOS Heart Center, Siegburg, Germany, performed the ReValving procedure ‘live’ via satellite television from the “cath lab” of the HELIOS Heart Center for a TCT audience in Washington, D.C. comprised of interventional cardiologists and industry business-development executives.

“Today’s successful ‘live’ ReValving procedure is part of the safety and efficacy clinical trials for our smaller 18-French system and, when combined with the excellent results of nearly 100 previous cases, demonstrates that interventional cardiology treatment of structural heart disease is no longer just a hope for the future, but a reality today,” said Jacques Séguin, M.D., Ph.D., Founder, Chairman and CEO of CoreValve.

Of special note: The ‘live’ ReValving™ procedure at TCT used CoreValve’s own proprietary porcine pericardium aortic heart valve, delivered via CoreValve’s small 18- French-sized catheter, and required less than 15 minutes to be implanted. As a result, this patient was not only able to avoid open-heart surgery to treat her defective aortic heart valve, but also is expected to require minimal rehabilitation before enjoying substantially enhanced quality of life.

About CoreValve
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 ReValvin ™ 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.)