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First 100 Patients Treated in Europe with the MitraClip(R) System for Percutaneous Mitral Repair
Date:5/14/2009

Use of the MitraClip(R) Therapy Continues to Expand in Europe

MENLO PARK, Calif., May 14 /PRNewswire/ -- Evalve, Inc., the leader in the development of devices for the percutaneous repair of cardiac valves, announced today that the first 100 patients have been treated with the MitraClip(R) system in Europe. Clinical results to date underscore the acute clinical benefit for patients, demonstrate the potential for reduced hospital stays and improved quality-of-life for patients. Of the procedures performed to date, 93% resulted in an implant and the vast majority resulted in a satisfactory reduction of mitral regurgitation, as described by the physician at the time of the procedure. The MitraClip(R) system is the only medical device commercially available in the European Union which provides a non-surgical mitral valve repair option for patients suffering from the effects of functional or degenerative mitral regurgitation (MR).

MR is the most common type of heart valve insufficiency in Europe and the United States, affecting millions of people worldwide. Significant MR affects more than eight million people in the US and Europe, the majority of which have FMR. There are more than 600,000 new diagnoses of significant MR each year in Europe and the US; however only 20 percent of these patients undergo surgery each year. Many higher risk surgical patients and non-surgical patients continue to be affected by the chronic volume overload caused by MR, which requires the heart to work harder, and may ultimately lead to heart failure.

"We have seen that the MitraClip(R) therapy provides a valuable alternative for patients who are considered high risk or otherwise not good candidates for surgery," said Olaf Franzen, M.D., interventionalist for adult structural and congenital heart disease at the University Heart Center in Hamburg, Germany, the institution having treated the most patients to date in Europe
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SOURCE Evalve, Inc.
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