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

THURSDAY, Nov. 3 (HealthDay News) -- The first artificial heart valve that can be implanted without open-heart surgery has been approved by the U.S. Food and Drug Administration.

The Sapien Transcatheter Heart Valve is designed to replace an aortic heart valve damaged by senile aortic valve stenosis, a progressive and age-related illness caused by calcium deposits that cause the valve to narrow.

One expert called the advent of the device "a revolutionary breakthrough" in terms of expanding access for sick or frail patients.

"This new approach to valve replacement is designed for the elderly and the highest risk patients who are inoperable -- or nearly inoperable -- by conventional criteria," said Dr. Gregory Crooke, assistant director of cardiothoracic surgery at Maimonides Medical Center in New York City, which is already offering the device to select patients. "As has been shown in trials, it should greatly improve the survival and quality of life for this cohort of patients," he said.

In aortic stenosis, the heart has to work harder to pump sufficient amounts of blood through the narrowed valve opening. This eventually causes the heart to weaken, leading to problems such as fainting, chest pain, heart failure, irregular heart rhythms, or cardiac arrest.

More than half of patients with symptoms of senile aortic valve stenosis die within two years. Open-heart surgery to replace the diseased valve can restore blood flow, but the procedure is too dangerous for some patients, the FDA noted in a news release.

The new artificial valve -- made of cow tissue and polyester supported with a stainless steel mesh -- provides an option for these patients. The valve is compressed into the end of a catheter that's inserted into a femoral artery (large artery in the thigh) and threaded to the site of the diseased valve. The artificial valve is then released from the catheter and expanded with a balloon. The valve is
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