The US Food and Drug Administration (FDA) has approved Edwards Lifesciences’ SAPIEN 3 transcatheter aortic valve replacement (TAVR) platform for the treatment of patients with asymptomatic severe aortic stenosis (AS), expanding its use to a broader population.
Marking a first approval for a TAVR system’s use in asymptomatic AS patients, the agency’s decision was based on data from Edwards’ EARLY TAVR trial.
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Published last year, the trial results demonstrated that asymptomatic severe AS patients randomised to Edwards’ TAVR experienced superior outcomes versus guideline-recommended clinical surveillance (watchful waiting).
With a median follow-up of 3.8 years, 26.8% of the 455 patients in the trial’s TAVR arm experienced death, stroke or unplanned cardiovascular hospitalisation versus 45.3% of the 446 patients in the clinical surveillance arm. The randomised control trial was the first to study the best approach to treating asymptomatic severe AS patients and evaluate the benefits of early intervention with TAVR.
Dr Philippe Genereux, director of the structural heart programme at Gagnon Cardiovascular Institute at Morristown Medical Center, asserted that there is an “urgent need” to change the TAVR treatment guideline’s ‘watchful waiting’ until symptoms develop approach to the care pathway for aortic stenosis patients.
According to data first shared by Edwards at the American College of Cardiology’s (ACC) Annual Scientific Session & Expo 2025 in March, one in ten patients experiencing symptoms of severe AS may die within five weeks if left untreated.
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By GlobalDataGenereux said: “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.”
Larry Wood, Edwards’ corporate vice president and TAVR and surgical group president, called the approval a “powerful opportunity” to streamline patient care and improve the efficiency of the healthcare system.
According to GlobalData analysis, the global TAVR market is forecast to reach a valuation of around $13.7bn by 2033, up from $6.16bn in 2023.
GlobalData’s US Healthcare Facility Invoicing Database indicates that Edwards Lifesciences is currently the TAVR market leader, holding more than 60% of the US TAVR market. But change may be afoot.
Medtronic recently released two-year results from a clinical trial comparing its Evolut system to Edwards’ SAPIEN, with the data showing that the Evolut system led to significantly less bioprosthetic valve dysfunction, five times less prosthetic valve thrombosis, and nine times less haemodynamic structural valve dysfunction than the SAPIEN system.
According to GlobalData analysis, the Evolut system could become the preferred option among healthcare professionals for patients with symptomatic severe aortic stenosis and small aortic annulus categories, as evaluated in the trial.
