The U.S. Food and Drug Administration today approved an expanded indication for the Sapien 3 Transcatheter Heart Valve (THV) for patients with symptomatic heart disease due to failure of a previously placed bioprosthetic aortic or mitral valve whose risk of death or severe complications from repeat surgery is high or greater.
“For the first time, a regulatory agency is approving a transcatheter heart valve as a valve-in-valve treatment when bioprosthetic mitral or aortic valves fail in patients who are at high or greater risk of complications from repeat surgery,” said Bram Zuckerman, M.D., director of the division of cardiovascular devices at the FDA’s Center for Devices and Radiological Health. “This new approval offers U.S. patients with failing surgical bioprosthetic aortic or mitral valves a less-invasive treatment option.”
A bioprosthetic aortic or mitral valve may fail over time due to stenosis, when the valve narrows and causes the heart to work harder to pump blood, regurgitation, when the valve does not close completely and blood leaks backwards, or a combination of both. Treatment would normally require repeat open heart surgery, which causes a high or greater risk of complications for certain patients.
The FDA originally approved the Sapien 3 THV for transcatheter aortic valve replacement (TAVR) as an alternative option to surgical aortic valve replacement for patients with native aortic stenosis whose risk for death or severe complications from surgery is high or greater. In 2016, the FDA expanded the approved the TAVR indication for Sapien 3 THV to include patients who are at intermediate surgical risk for death or complications. Today, the FDA is the first to approve an expanded use of the Sapien 3 THV as a valve-in-valve treatment. Valve-in-valve procedures offer an alternative to repeat surgery, since the replacement valve is inserted inside the failing surgical bioprosthetic valve through a patient’s blood vessel or a small cut in a patient’s chest.
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