Edwards’ Sapien 3 TAVR Platform Earns FDA Approval for Asymptomatic, Severe Aortic Stenosis

Edwards Lifesciences has earned U.S. Food and Drug Administration (FDA) approval of its Sapien 3 transcatheter aortic valve replacement (TAVR) for severe aortic stenosis (AS) patients without symptoms, marking the first FDA approval for TAVR in asymptomatic patients.

Approval of the platform—Sapien 3, Sapien 3 Ultra, and Sapien 3 Ultra Resilia—was based on data from the EARLY TAVR trial. The trial data showed asymptomatic severe AS patients using Edwards TAVR had superior outcomes compared to guideline-recommended clinical surveillance.

EARLY TAVR was the first randomized, controlled trial to evaluate TAVR compared to watchful waiting for asymptomatic severe AS. 26.8% of the 455 patients in the TAVR arm experienced death, stroke, or unplanned cardiovascular hospitalization—compared to 45.3% of 446 patients in the clinical surveillance arm.

“There is an urgent need to change practice and TAVR guidelines for the treatment of aortic stenosis patients, which currently recommend ‘watchful waiting’ until symptoms develop,” said Philippe Genereux, MD, director of the structural heart program at Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, N.J. “As we saw in the EARLY TAVR trial, patients originally designated as asymptomatic became symptomatic in sudden and unpredictable ways, underscoring the importance of early evaluation by a heart team to improve patient outcomes and benefit the healthcare system.”

Since its introduction over 20 years ago, more than one million patients have been treated with Sapien valves across the world.

“This approval is a powerful opportunity to streamline patient care and improve the efficiency of the healthcare system,” said Larry Wood, Edwards’ corporate vice president and group president, Transcatheter Aortic Valve Replacement and Surgical. “We are proud to partner with leading physicians to advance our knowledge of this deadly disease with high quality science and optimize the treatment pathway for patients.”

Last month, the company earned CE mark approval for its Sapien M3 mitral valve replacement system for transcatheter treatment of patients with symptomatic (moderate-to-severe or severe mitral regurgitation (MR) who are unsuitable for surgery or transcatheter edge-to-edge (TEER) therapy.