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First Patients Enrolled in the Access-Europe Study of The MitraClip(R) Therapy
Date:4/6/2009

European Post Market Observational Study Intended to Collect Data to Demonstrate the Clinical and Health Economic Benefits of the MitraClip(R) Therapy for Patients with Mitral Regurgitation

MENLO PARK, Calif., April 6 /PRNewswire/ -- Evalve, Inc., the leader in the development of devices for the percutaneous repair of cardiac valves, announced today the first enrollment in the ACCESS-Europe study, a post-market observational study of the MitraClip(R) therapy in Europe. The MitraClip(R) system is the first commercially available treatment option for non-surgical mitral valve repair for patients suffering from the effects of functional and degenerative mitral regurgitation (MR).

MR affects millions of people worldwide and is the most common type of heart valve insufficiency in Europe and the United States. In Europe, similar to the US, there are approximately 250,000 new diagnoses of significant MR each year; however, only 20 percent or approximately 50,000 of these patients undergo surgery each year. Non-surgical patients and many of the higher risk surgical patients continue to be affected by the chronic volume overload caused by MR, which requires the heart to work harder, which may lead to heart failure and hospitalization.

The first patients were enrolled in ACCESS-Europe by a team led by Professor Corrado Tamburino, M.D.; Gian Paolo Ussia, M.D.; Salvatore Scandura, M.D.; and Sarah Mangiafico, M.D. at Ferrarotto Hospital at Catania University in Sicily, Italy.

"ACCESS-Europe will provide important clinical care and health economic information about the MitraClip(R) therapy," said Professor Tamburino, chair of cardiology, cardiology department, cardiac catheterization and interventional cardiology, Ferrarotto Hospital, University of Catania, Sicily. "This data will allow us to further understand the benefits of the MitraClip(R)
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SOURCE Evalve, Inc.
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