Clip device accomplishes endovascular, non-surgical repair of faulty heart valve

March 9, 2004--A tiny metallic clip that can be delivered and attached to the heart's mitral valve with a catheter may eliminate the need for open-heart surgery in some patients who suffer from significant mitral regurgitation (MR). A debilitating condition, MR occurs when the valve, which allows blood to move through the heart, fails to close properly.

Early experience with the clip, which is being evaluated under an FDA approved Investigational Device Exemption, has been encouraging, says Principal Investigator Ted Feldman, MD, Director of the Cardiac Catheterization Lab at Evanston Hospital, flagship of the Evanston Northwestern Healthcare system. Evalve, Inc. (Redwood City, CA) developed and manufactures the system.

Dr. Feldman will present results of the Phase I trial at 9 a.m. CST Tuesday, March 9, at the American College of Cardiology Conference, Morial Convention Center, Hall A, New Orleans. The presentation, part of the Late-Breaking Clinical Trials II group, is titled Percutaneous Mitral Valve Repair Using the Edge-to-Edge Technique: Phase I US Trial Results.

To date, a total of 10 percutaneous mitral valve repairs using this device have been performed nationwide. Dr. Feldman performed the first U.S. procedure in Evanston Hospital's Cardiac Catheterization Laboratory. Other U.S. investigators participating in the trial are: Howard Herrmann, MD, University of Pennsylvania; Peter Block, MD, Emory University Hospital, Atlanta; Pat Whitlow, MD, Cleveland Clinic Foundation; William Gray, MD; Swedish Medical Center, Seattle; Kenneth Kent, MD, Washington Hospital Center, Washington, DC; and Hal Wasserman, MD, Columbia University Medical Center, New York.

"Collectively, we have used the clip in 10 patients without complications during the procedure. Prior to the catheter procedure all 10 patients had MR serious enough to require surgery. The majority of the patients treated with the device had their MR significantly reduced so a


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