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Two-Month Follow-up of First South-American Patient Shows 58-Year-Old Female is Fully Recovered and Has Resumed Normal Activity after Non-Surgical Replacement of Defective Aortic Heart Valve Using CoreValve's Breakthrough ReValving Procedure.

IRVINE, Calif., & PARIS -- One of an ongoing series of early cases that demonstrate CoreValve's ReValving(TM) approach is a successful alternative to open-heart surgery

"This patient's life has been transformed--without surgery--from being significantly debilitated to normal-functioning as a direct result of ReValving. The procedure was performed in a hospital cathlab (not a cardiac OR) and avoided massive open-chest and open-heart surgical trauma. There can be no more hesitation: percutaneous aortic valve replacement (PAVR) via CoreValve's ReValving approach represents the area of legitimate excitement for the future of interventional cardiology now that stenting and angioplasty are commonplace procedures."

Jacques Seguin, MD, PhD, Chairman, CEO and Founder, CoreValve

CoreValve (www.corevalve.com) announced today that clinical and CT-Scan controls performed two months after the first percutaneous ReValving(TM) procedure performed in South America to replace a patient's defective aortic heart valve without surgery showed excellent clinical condition and perfect functioning and anchoring of the new biological heart valve. On February 7, 2005, the Company's ReValving(TM) System was implanted percutaneously for the first time in a patient in South America. The procedure was completed in a cardiac catheterization laboratory ("cathlab") by a team of interventional cardiologists. As a result, the 58-year-old female patient was able to avoid open-heart surgery to treat her aortic valve regurgitation.

The successful procedure was performed by Dr. Jean-Claude Laborde (Clinique Pasteur, Toulouse, France), Dr. Carlos Ruiz (University of Illinois at Chicago), and Dr. Jose Antonio Condado of Hospital Miguel Perrez Carreno in Caracas, Venezuela (where the ReValving procedure was performed).

"It is important to note that this patient's pre-op condition was severely debilitated by a very substantial aortic regurgitation," said Dr. Jacques Seguin, founder, chairman and CEO of CoreValve. "In fact, she was confined to a bed or a chair ('functional class IV', New York Heart Association classification) for the most part," added Dr. Seguin. "Nevertheless, she was a candidate for open-heart surgery who opted for CoreValve's non-surgical ReValving approach to treat her defective aortic heart valve."

"We are extremely pleased to report that the ReValving procedure has enabled this patient to return to a normal life," Dr. Condado said. "She has absolutely no residual aortic valve insufficiency, and there has been improvement in her left ventricle function. Indeed, her cardiac function is now quite normal as demonstrated by her 'functional class I' NYHA classification."

"Executing this procedure in the cathlab has convinced me that ReValving has enormous potential to non-surgically treat both diseases of the aortic heart valve -- stenosis and regurgitation," added Dr. Ruiz.

"There can be no more hesitation: percutaneous aortic valve replacement (PAVR) via CoreValve's ReValving approach represents the area of legitimate excitement for the future of interventional cardiology now that stenting and angioplasty are commonplace procedures," concluded Dr. Seguin. "Based on positive early results from the ongoing feasibility clinical trials in Europe, South America and Asia Pacific, the Company has started planning for the definitive clinical trial of the ReValving System to obtain CE Marking."

About Aortic Regurgitation

Aortic regurgitation occurs when there is blood leakage through the valve backward into the left ventricle during diastole. Chronic aortic regurgitation may be present for decades before any symptoms occur. The left ventricle is able to compensate for the large volume of blood that flows backward by enlarging the cavity and increasing the thickness of the muscle. This mechanism allows the heart to pump out both the amount of blood required by the body and the blood that has gone backward into the left ventricle. When symptoms do occur, patients usually experience shortness of breath or chest discomfort. Long-standing aortic regurgitation may result in irreversible damage to the muscle of the left ventricle, even in the absence of symptoms.

Definitions of NYHA (New York Heart Association) Functional Classifications

NYHA "Functional Classification" refers to a functional and therapeutic classification of physical activity of cardiac patients. It is often used by physicians to describe the improvement of a patient. A two-class improvement is considered significant. -- Class I: patients with no limitation of activities; they suffer no symptoms from ordinary activities. -- Class II: patients with slight, mild limitation of activity; they are comfortable with rest or with mild exertion. -- Class III: patients with marked limitation of activity; they are comfortable only at rest. -- Class IV: patients who should be at complete rest, confined to bed or chair; any physical activity brings on discomfort and symptoms occur at rest.

About CoreValve

Privately held CoreValve, with U.S. headquarters in Irvine, Calif., 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(TM)--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. For more information about CoreValve, visit the Company's Web site at www.corevalve.com.

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.
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Publication:Business Wire
Date:Apr 4, 2005
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