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Evalve, Inc.: MitraClip(R) Therapy Data Demonstrate Significant Left Ventricular Reverse Remodeling in Patients With Sustained Reduction of Mitral Regurgitation


9/23/2009 10:21:58 AM

SAN FRANCISCO, Sept. 22 /PRNewswire/ -- Sustained reduction of mitral regurgitation following mitral valve repair with the MitraClip(R) system in patients with degenerative mitral regurgitation (DMR) or functional mitral regurgitation (FMR) led to heart function improvements, according to 12-month data from a subset of the initial registry cohort of the EVEREST (Endovascular Valve Edge-to-Edge REpair STudy) studies presented today at the Transcatheter Cardiovascular Therapeutics (TCT) Conference in San Francisco.

This subset of the initial EVEREST registry cohort was comprised of 79 patients with moderate-to-severe (grade 3+) or severe (grade 4+) MR who had discharge MR reduction to grade 2+ or less. Of the 79 patients, 73 percent had DMR and 27 percent had FMR, and 49 continued with a MitraClip(R) device with MR less than or equal to grade 2+ at 12 months. Matched core laboratory echocardiographic data was available at baseline and 12 months. Mean MR grade reduced from 3.1+/-0.7 at baseline to 1.4+/-0.5 at 12 months. Multiple indices of left ventricle function improved significantly (LV volumes, LV mass, LV sphericity and forward stroke volume), and there was no significant change in annular dimensions.

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 in Europe. The MitraClip(R) system is currently in late stage clinical trials in the United States.

About the MitraClip(R) Procedure

Mitral repair with Evalve's MitraClip(R) device is performed by physicians in the catheterization laboratory. The heart beats normally during the procedure, and therefore does not require a heart-lung bypass machine. In addition to improving blood flow through the heart, the procedure may also relieve symptoms such as fatigue and shortness of breath that often affect patients with significant MR. After treatment, patients generally recover quickly. The MitraClip(R) device may improve quality of life and may help MR patients avoid or delay surgery, having preserved surgical options (valve repair or replacement) should surgery become necessary.

MitraClip(R) and Evalve are registered trademarks of Evalve, Inc.

Evalve, Inc.



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