Edwards’ Sapien 3 TAVR Platform Approved for Asymptomatic Severe Aortic Stenosis

May 1, 2025—Edwards Lifesciences announced that the FDA has approved its Sapien 3 transcatheter aortic valve replacement (TAVR) platform for asymptomatic severe aortic stenosis (AS) patients. The Sapien platform includes the Sapien 3, Sapien 3 Ultra, and Sapien 3 Ultra Resilia devices, advised the company.

According to Edwards, this approval of the Sapien 3 platform is based on data from the EARLY TAVR trial, which demonstrated that asymptomatic severe AS patients randomized to treatment with Edwards’ TAVR platform experienced superior outcomes compared to guideline-recommended clinical surveillance (“watchful waiting”). The trial, with a median follow-up of 3.8 years, showed 26.8% of the 455 patients in the TAVR arm experienced death, stroke, or unplanned cardiovascular hospitalization, compared with 45.3% of the 446 patients in the clinical surveillance arm, reported the company.

The EARLY TAVR findings were presented at TCT 2024, the 36th annual Transcatheter Cardiovascular Therapeutics annual scientific symposium of the Cardiovascular Research Foundation held October 27-30 in Washington, DC, and simultaneously published by Philippe Généreux, MD, et al in The New England Journal of Medicine (2025;392:217-227).

“There is an urgent need to change practice and TAVR guidelines for the treatment of AS patients, which currently recommend ‘watchful waiting’ until symptoms develop,” commented Dr. Généreux in Edwards’ press release. “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 health care system.”

Dr. Généreux is Director of the Structural Heart Program at Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, New Jersey.