FDA approves expanded use of Sapien 3 heart valve

The U.S. Food and Drug Administration (FDA) approved an expanded indication for the Sapien 3 Transcatheter Heart Valve, a move that will allow physicians to use the device to better treat patients with symptomatic heart disease.

The Sapien 3, manufactured by Edwards Lifesciences, is used in patients who previously had a bioprosthetic aortic or mitral valve failure, and are now at risk of death or severe complications, according to a June 5 press release announcing the approval.

The FDA originally approved the device for transcatheter aortic valve replacements (TAVR) as an alternative option to surgical aortic valve replacements for patients suffering from native aortic stenosis. In 2016, the FDA expanded the use of the Sapien 3 again to include patients who are at intermediate surgical risk for death and complications, and now it’s the first to approve it as a valve-in-valve treatment.

"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, MD, director of the division of cardiovascular devices at the FDA's Center for Devices and Radiological Health, in a statement. "This new approval offers U.S. patients with failing surgical bioprosthetic aortic or mitral valves a less-invasive treatment option."

The FDA based its approval on data from the Transcatheter Valve Therapy Registry, which is provided by the American College of Cardiology and the Society of Thoracic Surgeons. The data showed that more than 85 percent of patients who received aortic or mitral valve-in-valve procedures saw an improvement in their heart failure symptoms after 30 days.