The FDA has approved the SAPIEN 3 transcatheter aortic valve replacement (TAVR) system for the treatment of severe aortic stenosis (AS) in asymptomatic patients. This marks the first time TAVR therapy has been approved for use in this patient population. The FDA granted approval to the entire SAPIEN 3 product line, including the SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA valves.
This approval is based on strong results from the EARLY TAVR trial, which demonstrated that treating asymptomatic patients with Edwards’ TAVR system led to significantly better outcomes than the current standard of clinical surveillance, commonly known as “watchful waiting.” Aortic stenosis is a progressive disease that advances rapidly through its stages.
Patients often begin the disease without noticeable symptoms, but its serious and potentially life-threatening nature becomes evident once symptoms appear. Symptomatic patients who remain untreated face a mortality risk of 1 in 10 within five weeks of symptom onset. Detecting the disease early is challenging, as symptoms often go unnoticed or develop suddenly.
Dr. Philippe Genereux from Gagnon Cardiovascular Institute in Morristown, New Jersey, emphasizes the urgent need to change the existing therapeutic recommendations. The EARLY TAVR trial showed that patients who initially appeared asymptomatic turned symptomatic without any warning signs. Early evaluation and treatment can improve outcomes and help reduce long-term strain on the healthcare system.
Since its inception, research among cardiologists has focused on examining TAVR use for asymptomatic patients. New data from the EARLY TAVR clinical trial emerged at TCT 2024, during late-breaking sessions in Washington, D.C., in late 2024.
The EARLY TAVR trial was the first successful randomized controlled trial to compare TAVR with standard care in patients with severe aortic stenosis (AS) who were asymptomatic. During the 3.8-year median follow-up period, patients who received TAVR experienced stroke, death, or unplanned cardiovascular hospitalization in 26.8% (455 patients). In contrast, the clinical surveillance group experienced a higher incidence rate of 45.3% (446 patients). The trial’s findings were published in The New England Journal of Medicine, marking the ninth NEJM article documenting the Edwards TAVR platform.
This approval is a crucial development that delivers better treatment to patients affected by severe aortic stenosis, stated Larry Wood, corporate vice president and group president for TAVR and surgical therapies at Edwards. “We’re proud to partner with leading clinicians and continue advancing research to better treat this life-threatening condition.”
The SAPIEN valve platform, in use for over two decades, is the most extensively studied valve system worldwide. To date, more than 1 million patients globally have been treated with a SAPIEN valve.
Reference: Edwards Lifesciences. Edwards TAVR receives FDA approval for patients with asymptomatic severe aortic stenosis. Published May 1, 2025. Â https://ir.edwards.com/news/news-details/2025/Edwards-TAVR-Receives-FDA-Approval-for-Patients-With-Asymptomatic-Severe-Aortic-Stenosis/default.asp
