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FDA OKs Heart Valve That Does Not Require Open-Heart Surgery
Date:11/3/2011

luate patient outcomes through a national registry.

The FDA approved the Sapien Transcatheter Heart Valve for patients who are not eligible for open-heart surgery, but it is not approved for those who can be treated by open-heart surgery. The agency also said that patients with congenital heart valve abnormalities, masses or an infection in their hearts, or those who cannot tolerate anticoagulation/antiplatelet therapy should not receive the new valve.

The valve's product label says a heart surgeon should be involved in determining if a patient is a suitable candidate for the artificial valve.

More information

The U.S. National Heart, Lung, and Blood Institute has more about heart valve problems.

-- Robert Preidt

SOURCES: U.S. Food and Drug Administration, news release, Nov. 2, 2011; Gregory Crooke, MD, assistant director, cardiothoracic surgery, Maimonides Medical Center, New York City; James Slater, M.D., director, Cardiac Catheterization Lab, NYU Langone Medical Center, New York City


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