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EVEREST Data Demonstrates Acute Reduction of Mitral Regurgitation Without Procedural Mortality in Patients Treated With the MitraClip(R) Therapy
Date:8/12/2009

MENLO PARK, Calif., Aug. 18 /PRNewswire/ -- Data published today in the Journal of the American College of Cardiology (JACC) indicates that percutaneous valve repair with the MitraClip(R) therapy can reduce acute mitral regurgitation (MR) with sustained freedom from death, surgery or recurrent MR in a substantial proportion of functional and degenerative MR patients.

The published data is from the initial cohort of 107 registry patients treated in the EVEREST (Endovascular Valve Edge-to-Edge REpair STudy) trial, sponsored by Evalve, Inc.

Seventy-four percent of patients achieved MR reduction to 2+ or less after receiving the MitraClip(R) device. In 64 percent of these, MR reduction to 1+ was achieved. Additionally, there were no cases of clip embolization or procedural mortality. Kaplan-Meier freedom from surgery was 88.5 percent, 83.2 percent and 76.3 percent at 1, 2 and 3 years, respectively. Whereas prior to the MitraClip(R) procedure 100 percent of patients were indicated for surgery.

The MitraClip(R) system is the first commercially available treatment option for non-surgical mitral valve repair for patients suffering from the effects of MR. The MitraClip(R) system is currently in late stage clinical trials in the United States and is available commercially in Europe.

MR is the most common type of heart valve insufficiency in Europe and the United States, and affects millions of people worldwide. Significant MR affects more than eight million people in the U.S. and Europe the majority of which have functional MR. There are more than 600,000 new diagnoses of significant MR each year in Europe and the U.S.; 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
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SOURCE Evalve, Inc.
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