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MitraClip(R) Therapy Data Demonstrate Significant Reduction in Mitral Valve Annulus Dimensions in High-Risk Patients With Functional Mitral Regurgitation
Date:9/22/2009

SAN FRANCISCO, Sept. 22 /PRNewswire/ -- Twelve-month data from EVEREST II (Endovascular Valve Edge-to-Edge REpair STudy) study high-risk registry arm presented today at the Transcatheter Cardiovascular Therapeutics (TCT) Conference in San Francisco show that high risk patients with functional mitral regurgitation (MR) following valve repair with the MitraClip(R) system showed a reduction in mitral annular dimension, improvement in heart function and a reduction in hospitalization for congestive heart failure.

The data were presented today by Saibal Kar, M.D., director of interventional cardiac research at Cedars-Sinai Medical Center, Los Angeles, CA and the lead enrolling investigator of the EVEREST II trial. The EVEREST II study was designed to evaluate the MitraClip(R) system for the treatment of MR.

This data included 34 patients from the high-risk registry with moderate-to-severe (3+) or severe (4+) functional mitral regurgitation who received a MitraClip(R) device and had matched core laboratory echocardiographic data at baseline and 12 months. Results included a mean MR grade reduction from 3.2+/-0.5 at baseline to 1.8+/-0.9 at 12 months. In addition to the reduction of MR, there was significant reduction in the systolic and diastolic septo-lateral mitral annular diameter as well as a significant reduction in left ventricular end diastolic and systolic volumes. Left ventricular ejection fraction (LV EF) did not change significantly from baseline, while forward stroke volume (FSV) improved, indicating improved cardiac efficiency. Results were as follows:

Baseline and 1 year echocardiographic results

                                           Baseline      1 year       p-value
                                           --------      ------       -------
    MR (n=34)                              3.2+/-0.5    1.8+/-0.9
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SOURCE Evalve, Inc.
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