The News

First percutaneous aortic valve replacement (PAVR) procedure without any cardiac support (i.e., mechanical assistance or accelerated pacing) performed with CoreValve’s non-surgical ReValving™ system

13/11/2006

“This milestone is as important for the CoreValve ReValving technology as the first-ever procedure was—not only because it avoided open-heart surgery for these very frail patients, but also because these uneventful procedures were performed in a cath lab without the use of extracorporeal bypass, or cardiac assistance, or even rapid pacing. ReValving is rapidly becoming very similar to a routine cath lab intervention.”
Jacques Séguin, M.D., Ph.D., Chairman, CEO and Founder of CoreValve

IRVINE, Calif., Nov. 13, 2006—CoreValve announced today that its patented ReValving System, consisting of a breakthrough 18-French-sized delivery catheter, was used to percutaneously implant its proprietary porcine pericardial tissue bioprostheses over the severely calcified aortic heart valves of an 88-year-old female patient and a 77-year-old male patient—without the use of extracorporeal bypass, other cardiac assistance or even rapid pacing. These first-ever medical-milestone procedures took routine interventional times to complete, and the patients were released from the ICU within hours of the completion of the ReValving procedure and are awaiting discharge from the hospital.

The successful procedures were performed at the HELIOS Heart Center (HHC), Siegburg, Germany, by Eberhard Grube, M.D., Chief of Cardiology and Angiology at HHC and a consulting professor of medicine at Stanford University

“Since we performed the very first cases two years ago, ReValving continues to evolve toward a simple and straightforward cath lab procedure,” said Dr. Grube. “The clinical investigators are gradually eliminating those procedural elements that are less conducive to the cath lab setting, and I commend the Company and its Scientific Advisory Board for designing study protocols that allow for procedural progress without compromising patient safety. As the clinical experience in Europe and North America now approaches 100 cases, there is no question in my mind that many patients in the future will be able to have their diseased aortic heart valve replaced percutaneously in a cath lab rather than having to endure open-heart surgery.”

“This latest clinical accomplishment substantiates our conviction that aortic valve replacement is no longer limited to surgical or mere transcatheter alternatives and fortifies CoreValve’s position as the undeniable leader in truly percutaneous valve replacement. We continue to work hard toward earning a CE Mark and first-to-market position for our ReValving System in Europe,” said Jacques Séguin, M.D., Ph.D., Chairman, CEO and Founder of CoreValve.

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 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.)