Irvine, Calif.– Edwards Lifesciences has received U.S. Food and Drug Administration (FDA) approval to expand the use of its SAPIEN 3 transcatheter aortic valve replacement (TAVR) platform to include patients with severe aortic stenosis (AS) who are asymptomatic—a historic first for the treatment category.
The decision marks a major shift in the management of aortic stenosis, a condition in which the aortic valve narrows, restricting blood flow from the heart. Traditionally, treatment guidelines have advised “watchful waiting” until symptoms such as chest pain or breathlessness appear. However, findings from the pivotal EARLY TAVR trial challenge that approach, showing that proactive intervention can significantly improve outcomes even before symptoms develop.
“There is an urgent need to change practice and TAVR guidelines,” said Dr. Philippe Genereux, director of the structural heart program at Morristown Medical Center in New Jersey. “As we saw in the EARLY TAVR trial, patients initially thought to be asymptomatic often developed symptoms quickly and unpredictably. Early treatment can prevent adverse events and improve survival.”
The EARLY TAVR trial is the first randomized controlled study comparing TAVR with clinical surveillance in patients with asymptomatic severe AS. With a median follow-up of nearly four years, results showed that 26.8% of patients who received TAVR experienced death, stroke, or unplanned cardiovascular hospitalization, compared to 45.3% of those in the watchful waiting group. The findings were published in The New England Journal of Medicine, representing the ninth NEJM publication focused on Edwards’ TAVR technologies.
Edwards’ newly approved indication includes the full SAPIEN 3 platform—SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA valves. These devices offer a less invasive alternative to open-heart surgery, especially for patients at elevated risk due to age or comorbidities.
“This approval is a powerful opportunity to streamline patient care and reduce the burden on the healthcare system,” said Larry Wood, corporate vice president and group president of TAVR and Surgical at Edwards. “We’re proud to continue leading with strong clinical evidence and to offer patients a life-saving option before their disease becomes more advanced.”
With more than 1 million patients treated globally, the SAPIEN platform is the most studied and widely used transcatheter valve system. FDA approval for use in asymptomatic patients represents a critical advancement in early intervention for heart valve disease, offering new hope to those at risk of sudden cardiac decline.
