The federal safety watchdog said the expansion is the 1st approval for a transcatheter valve replacement for valve-in-valve procedures when the original surgically implanted valves fail. The procedure involves inserting the Sapien 3 device inside the failed or failing valve.
“For the 1st 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,” Dr. Bram Zuckerman, director of the division of cardiovascular devices at the FDA’s Center for Devices & Radiological Health, said in prepared remarks. “This new approval offers U.S. patients with failing surgical bioprosthetic aortic or mitral valves a less-invasive treatment option.”
The FDA approved the Sapien 3 device for transcatheter aortic valve replacement in June 2015 for inoperable or high-risk patients. In August 2016 that indication was expanded to include intermediate-risk patients, another 1st.
The agency said it made the decision based on data from the Transcatheter Valve Therapy Registry for 314 aortic ViV patients and 311 patients who had mitral ViV procedures, showing that more than 85% “experienced clinically meaningful improvement in their heart failure symptoms” at 30 days.
“In both aortic and mitral valve-in-valve patients, the observed mortality rates were substantially lower than the expected mortality rate for repeat surgery,” according to the FDA.
Edwards will join the Society of Thoracic Surgeons and the American College of Cardiology as a stakeholder in the TVT registry study to ensure 5 years of post-approval data, the FDA said.
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