June 6, 2017 — The U.S. Food and Drug Administration (FDA) has granted market clearance for aortic and mitral valve-in-valve procedures using the Edwards Lifesciences Sapien 3 transcatheter heart valve (THV). The Sapien 3 valve is the first transcatheter heart valve approved in the U.S. for the treatment of both aortic and mitral patients who are at high risk for a subsequent open-heart surgery to replace their bioprosthetic valve.
"This approval brings a safe and effective transcatheter therapy to patients who would do very poorly with repeat open-heart surgery," said John Carroll, M.D., professor of cardiology at the University of Colorado School of Medicine and director of interventional cardiology at the University of Colorado Hospital, Denver, and member of the TVT Registry Steering Committee. "I am pleased to see that the FDA recognizes the value of the high-quality evidence generated by the STS-ACC TVT Registry and its ability to play an important role in assessing 'real-world' clinical results in specialty indications, such as valve-in-valve, and for particular patient groups, such as those needing replacement of a bioprosthetic mitral valve."
This anticipated FDA approval of the indication expansion was supported by real-world data collected from the Society of Thoracic Surgeons and American College of Cardiology (STS/ACC) Transcatheter Valve Therapy (TVT) Registry. The TVT Registry includes information and outcomes on patients undergoing transcatheter valve replacement and repair procedures in the United States.
The FDA evaluated data from the registry outcome to support the marketing application. It consisted of 314 patients who had undergone aortic valve-in-valve procedures and 311 patients who had undergone mitral valve-in-valve procedures. The registry data showed that more than 85 percent of patients who underwent aortic or mitral valve-in-valve procedures experienced clinically meaningful improvement in their heart failure symptoms 30 days after the procedure, as shown by their New York Heart Association (NYHA) Classifications. The NYHA Classification is a common classification system by which heart failure symptoms are rated. In both aortic and mitral valve-in-valve patients, the observed mortality rates were substantially lower than the expected mortality rate for repeat surgery.
The FDA sent a press release for the new indication, which it usually does only for new innovations that may have a larger impact on healthcare.
"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."
The FDA said Sapien 3 THV is indicated for use in patients who previously received a tissue aortic or mitral valve that has become narrowed, leaky or both, so blood is not able to flow efficiently through the valve. The Sapien 3 THV was previously approved for patients whose own native aortic valves become narrowed by aortic stenosis. As the heart works harder to pump enough blood through the valve, it eventually weakens, which can lead to life-threatening heart problems such as fainting, chest pain, heart failure, arrhythmia or cardiac arrest.
The FDA stated the Sapien 3 THV should only be used in patients who are at high or greater risk of death or serious complications from traditional open-heart surgery to replace the failed surgical tissue valve, as determined by their heart team composed of a cardiologist and surgeon.
As part of the approval, the manufacturer will participate as a stakeholder of the STS/ACC Transcatheter Valve Therapy Registry to ensure FDA surveillance for the device over the next five years.
The Sapien 3 valve was approved by the FDA in 2015 for severe, symptomatic aortic stenosis patients at high risk for open-heart surgery, and, in 2016, received approval for the treatment of patients who are at intermediate risk for open-heart surgery. The Sapien 3 valve builds on Edwards' decades of experience in the development of tissue heart valves, and the proven benefits of the Sapien valves.
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For more information: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm561924.htm
December 20, 2023 
