The News

Breakthrough ReValving(TM) Device Developed by CoreValve, S.A., May Provide Preferred Alternative to Open-Heart Surgery

20/07/2004

Paris--(BUSINESS WIRE)--July 20, 2004

"ReValving--that is, percutaneously implanting a new heart valve over a defective valve instead of cutting it out--redefines the way valve replacement is performed, changing it from a very complex surgical procedure to a relatively simple, less invasive one. In short, ReValving is the next-generation cath lab therapy for interventional cardiology." -- Jacques Seguin, MD, PhD, Chairman, CEO and Co-Founder, CoreValve, S.A.

CoreValve S.A., a privately held medical technology company, announced today that its proprietary self-expanding stented aortic heart valve has been implanted successfully in a human, for the first time, using the CoreValve percutaneous ReValving(TM) system in the cardiac catheterization ("cath") laboratory of a hospital in Asia. As a result, the 62-year-old male patient was able to avoid open-heart surgery to treat his aortic calcified stenosis.

The first-of-its-kind procedure on a human was performed by two interventional cardiologists: Dr. Eberhard Grube, chief of cardiology and angiology at the Heart Center, Siegburg, Germany, and a consulting professor of medicine at Stanford University; and Dr. Jean-Claude Laborde, an interventional cardiologist at Clinique Pasteur, Toulouse, France, who has had extensive preclinical experience with the CoreValve Percutaneous ReValving System(TM).

"Our patient has a frail heart and had been deemed a high surgical risk because of his deteriorated condition and extensive polyvisceral disease," said Dr. Grube. "Given the lack of any other therapeutic solution for this patient, the CoreValve ReValving approach has proved to be a life-saving technology. We are extremely proud to be the world's first interventional cardiologists to use this breakthrough technology successfully in a human, which no doubt represents a whole new frontier for heart valve replacement."

"Our patient's blood flow was restored to normal almost immediately, and his heart function has improved dramatically," added Dr. Laborde. "The CoreValve catheter-based delivery system adapted readily to our patient's local anatomical constraints, empowering us to deliver the self-expanding stented heart valve to its precise location with the correct orientation. Assuming confirmation of this first success in the near future in other patients, we believe the CoreValve ReValving approach will become the non-surgical option of choice for high-risk patients with aortic stenosis."

"We believe that CoreValve has redefined the way heart valve replacement will be performed in the future. The ability to resolve a patient's aortic stenosis by performing the CoreValve ReValving procedure in a cath lab is truly a revolutionary event for interventional cardiology. Indeed, we believe this ranks in importance alongside the first angioplasty performed in a human 27 years ago by Dr. Andreas Gruentzig," said Dr. Jacques Seguin, chairman, CEO and founder of CoreValve.

"This event represents a historic moment in medicine: Dr. Grube and Dr. Laborde were able to cure with the CoreValve device the severely stenotic and calcified aortic valve of a 62-year-old male patient. The results show a perfect implantation, absence of transvalvular gradient, and no significant valvular regurgitation, either centrovalvular or paravalvular. This result indicates clearly the feasibility of our technology and will allow us to pursue our feasibility trial in the weeks to come," said Dr. Seguin.

"We believe the CoreValve ReValving approach significantly reduces the total cost per patient; reduces hospital stay, and dramatically reduces a patient's overall recovery time," added Dr. Seguin. "It also is important to note that there are thousands of patients with aortic stenosis who are not good candidates for open-heart surgery who could benefit from CoreValve's much-less-invasive alternative."

CoreValve's self-expanding stented heart valve and universal catheter-based delivery system have numerous advantages for the patient: (1) Self-expansion avoids the need for lengthy aortic-ballooning--which interrupts blood flow to the brain and the coronaries--and also ensures stability during implantation by reducing hemodynamic pressure on the delivery catheter; (2) Self-expansion is able to adapt to a non-tubular (i.e., not perfectly round) aortic anatomy, which ensures continually persistent radial force despite varying annulus diameters during the cardiac cycle; (3) Self-expansion protects the replacement heart valve by avoiding the possibility of balloon-related leaflet trauma; (4) The self-expanding stent reduces dramatically the risk of paravalvular leaks.

Aortic stenosis is a narrowing of the heart valve that causes the heart to work very hard in order to eject blood from the heart, resulting in shortness of breath and, in advanced cases, fainting and heart failure. Today, symptomatic patients are typically treated by traditional open-heart surgery; about 220,000 patients worldwide have surgery on their heart valves. About 60 percent of valve replacement surgeries are for the aortic valve. Aortic stenosis occurs predominantly in men and women over 70 years of age. Many of these patients are at high risk of surgical complications because of other complicating illnesses, or co-morbidities.

About CoreValve
Privately held CoreValve, S.A., headquartered in Paris, France, has developed a proprietary delivery system for percutaneous heart valve replacement, based on a novel catheter-and-self-expanding-stent approach on a beating heart, thus avoiding open-heart surgery. The CoreValve Percutaneous ReValving System(TM) can be adapted to any biological valve currently marketed or synthetic valve in development. The CoreValve procedure 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.