FDA Approves Edwards' TAVR for Asymptomatic Aortic Stenosis

The FDA has approved Edwards Lifesciences' SAPIEN 3 transcatheter aortic valve replacement (TAVR) platform for use in asymptomatic patients with severe aortic stenosis, marking the first such approval for this patient group. This decision is based on results from the EARLY TAVR trial, which showed that patients receiving TAVR experienced significantly better outcomes—including lower rates of death, stroke, and unplanned cardiovascular hospitalization—compared to those managed by watchful waiting, the current guideline-recommended approach. The trial followed patients for a median of 3.8 years and highlighted the unpredictable onset of symptoms in severe aortic stenosis, underscoring the importance of early intervention. Medical experts, including Dr. Philippe Genereux, have called for updates to treatment guidelines to reflect these findings and improve patient care. Edwards Lifesciences' financial position and longstanding investment in TAVR research further support its ability to continue advancing treatment innovations. The approval is expected to streamline patient care and enhance healthcare efficiency for those at risk of rapid disease progression.