Evalve Announces Enrollment Completion of the EVEREST Random...( EVEREST Becomes First Trial of its ...),Health

EVEREST Becomes First Trial of its Kind to Achieve Enrollment Milestone

MENLO PARK, Calif., Sept. 30 /PRNewswire/ -- Evalve, Inc., the leader in the development of devices for the percutaneous repair of cardiac valves, announced today the completion of randomized enrollment in the Endovascular Valve Edge-to-Edge REpair STudy (EVEREST), which is evaluating the MitraClip(R) system as a non-surgical repair option for patients suffering from mitral regurgitation (MR). MR is the most common type of heart valve insufficiency in the United States, affecting millions of people worldwide.

"The completion of enrollment in the randomized trial is an important milestone for the field of cardiology," said Ted Feldman, M.D., director of the cardiac catheterization lab at Evanston Northwestern Hospital and co-principal investigator of the trial. "It is the first randomized trial of any percutaneous mitral repair device compared to mitral valve surgery, and also the first large prospective evaluation of current mitral valve surgery using an independent core laboratory."

EVEREST is a U.S. Food and Drug Administration (FDA) approved Phase II randomized, controlled, multi-center clinical research study in the United States and Canada evaluating the safety and efficacy of the MitraClip device in 279 patients with moderate-to-severe (3+) or severe (4+) MR, as compared to surgical repair or replacement. The study effectiveness endpoint requires an MR reduction to less than or equal to 2+ at one year. The primary effectiveness endpoint is freedom from surgery for valve dysfunction, death, and moderate-to-severe or severe mitral regurgitation at 12 months. The primary safety endpoint is freedom from major adverse events (MAE) at 30 days or hospital discharge whichever is longer.

Evalve received CE Mark approval for the MitraClip device earlier this year and the first series of patients were recently treated in Germany. The MitraClip system is the only comme
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