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FDA Approves First Artificial Aortic Heart Valve Placed Without Open-Heart Surgery
Date:11/2/2011

SILVER SPRING, Md., Nov. 2, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved the first artificial heart valve that can replace an aortic heart valve damaged by senile aortic valve stenosis without open-heart surgery.

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Senile aortic valve stenosis is a progressive, age-related disease caused by calcium deposits on the aortic valve that cause the valve to narrow. As the heart works harder to pump enough blood through the smaller valve opening, the heart eventually weakens, which can lead to problems such as fainting, chest pain, heart failure, irregular heart rhythms (arrhythmias), or cardiac arrest.  

Once symptoms of senile aortic stenosis occur, more than half of patients die within two years. To restore normal blood flow, patients with severe aortic valve stenosis need open-heart surgery to replace the diseased valve. However, the procedure is too risky for some patients.

"Surgery to replace the aortic valve is an effective treatment for severe senile aortic valve stenosis. The Sapien Transcatheter Heart Valve (THV) is an example of an innovative new device that will provide some people with this condition who can't undergo open heart surgery with the option of valve replacement," said Jeffrey Shuren, M.D., director of the FDA's Center for Devices and Radiological Health. "The agency remains committed to working with companies who are developing breakthrough treatments that will have a significant impact on patient care in the U.S."

The Sapien THV is made of cow tissue and polyester supported with a stainless steel mesh frame. To replace the diseased valve, the Sapien THV is compressed into the end of a long, thin, tube-like device called a delivery catheter. The delivery catheter, which is slightly wider than a pencil, and the Sapien THV are inserted into the femoral artery through a small cut in the leg and threaded to the si
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SOURCE U.S. Food and Drug Administration
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