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.