In a groundbreaking decision, the U.S. Food and Drug Administration (FDA) has approved the Sapien 3 transcatheter aortic valve replacement (TAVR) platform from Edwards Lifesciences for the treatment of asymptomatic severe aortic stenosis (AS). This approval marks the first time that any TAVR technology has been approved for asymptomatic patients. The approval encompasses the Sapien 3, Sapien 3 Ultra, and Sapien 3 Ultra Resilia valves.
The Path to FDA Approval:
The approval follows the pivotal findings from the EARLY TAVR clinical trial, which demonstrated the benefits of early TAVR intervention for patients with asymptomatic severe AS. The trial enrolled 901 patients, all aged 65 or older, who were randomly assigned to either receive TAVR or be monitored with clinical surveillance.
Key Findings:
- TAVR was associated with significantly lower rates of all-cause mortality, stroke, and unplanned cardiovascular hospitalizations (26.8% for TAVR vs. 45.3% for surveillance).
- Unplanned hospitalizations were reduced by nearly half in the TAVR group (20.9%) compared to the surveillance group (41.7%).
- KCCQ scores, which measure health status, were notably better for TAVR patients, with 86.8% of them maintaining a favorable health status at two years post-treatment.
Industry Impact:
The success of EARLY TAVR has led to a major shift in how cardiologists view the treatment of asymptomatic severe AS. Dr. Philippe Généreux, lead investigator of the trial, stressed the urgent need to update clinical guidelines to support early intervention with TAVR, as symptoms can develop suddenly and unpredictably. He called for early evaluation by heart teams to improve patient outcomes and optimize healthcare efficiency.
As Prof. Bernard Prendergast from Cleveland Clinic London stated, this approval represents a major reset in the approach to severe asymptomatic AS, with early diagnosis and intervention now being critical to improving patient care.
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