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

te of the diseased valve. The heart valve is then released from the delivery catheter and expanded with a balloon and is immediately functional.  

The FDA's approval of the Sapien THV is based on a study in 365 patients who were not eligible for open-heart surgery. Half of the patients received the Sapien valve. The other study patients received another treatment that did not require open-heart surgery. One alternative procedure involved enlarging the aortic valve opening by stretching it with a balloon (balloon valvuloplasty).

Patients receiving the Sapien valve experienced two and a half times more strokes and eight times as many vascular and bleeding complications than patients who did not receive the implant; however, they were more likely to survive one year after surgery. After a year, 69 percent of the Sapien patients were alive compared with 50 percent of those who received an alternative treatment.

Edwards Lifescience, the manufacturer of the Sapien THV, will continue to evaluate the outcomes with the Sapien THV through a national Transcatheter Valve Therapy (TVT) registry. The Society of Thoracic Surgeons and the American College of Cardiology have been working with the FDA and the Centers for Medicare and Medicaid Services to facilitate the creation of the national TVT registry that will serve as a platform for continued evaluation of post market experience with this and future transcatheter devices and procedures for the treatment of aortic stenosis.

The most common serious and potentially life-threatening side effects in patients receiving the Sapien valve and the procedure to implant the valve include death, stroke, perforation of the blood vessels, ventricle or valvular structures, damage to the conduction system in the heart, significant bleeding, and leaks around the new valve.

The Sapien THV is approved for patients who are not eligible for open-heart surgery for replacement of their aortic valve and have
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SOURCE U.S. Food and Drug Administration
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