SHERIDAN, WYOMING – May 7, 2025 – Edwards Lifesciences (NYSE: EW) has announced the U.S. Food and Drug Administration (FDA) approval of its transcatheter aortic valve replacement (TAVR) therapy, the SAPIEN 3 platform, for use in patients with asymptomatic severe aortic stenosis (AS). This groundbreaking approval marks the first-ever FDA authorization for TAVR in asymptomatic patients, potentially transforming the treatment landscape for those with this critical condition.
A Game-Changing Approval for the AS Treatment Landscape
The FDA’s decision to approve the SAPIEN 3 platform (including SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA) for asymptomatic severe aortic stenosis patients is based on the impressive findings from the EARLY TAVR trial. This trial demonstrated that asymptomatic patients who underwent TAVR treatment experienced significantly better clinical outcomes compared to those who were subjected to traditional clinical surveillance or "watchful waiting."
Severe aortic stenosis (AS), a condition where the aortic valve narrows, can be deadly if left untreated, with 1 in 10 symptomatic patients facing a potential death within five weeks. However, AS symptoms can often be challenging to detect, making early intervention crucial. This new FDA approval is expected to save lives and optimize patient care by addressing AS earlier in its progression.
The EARLY TAVR Trial: Pioneering Clinical Data
The EARLY TAVR trial is the first randomized, controlled study comparing TAVR therapy to watchful waiting in asymptomatic severe AS patients. The trial involved 455 patients who received TAVR and 446 patients who were monitored via clinical surveillance. After a median follow-up of 3.8 years, the results were clear:
- 26.8% of patients in the TAVR group experienced death, stroke, or unplanned cardiovascular hospitalization.
- In comparison, 45.3% of patients in the clinical surveillance group faced these adverse events.
The trial’s findings, published in The New England Journal of Medicine last year, confirm the superiority of TAVR over traditional surveillance, supporting its potential to revolutionize AS treatment.
Expert Insight: A Shift in Treatment Paradigms
Dr. Philippe Genereux, Director of the Structural Heart Program at the Gagnon Cardiovascular Institute in Morristown, New Jersey, emphasized the importance of the approval, stating, “There is an urgent need to change practice and TAVR guidelines for the treatment of aortic stenosis patients, which currently recommend ‘watchful waiting’ until symptoms develop. As we saw in the EARLY TAVR trial, patients originally designated as asymptomatic became symptomatic in sudden and unpredictable ways, underscoring the importance of early evaluation by a heart team to improve patient outcomes and benefit the healthcare system.”
This approval underscores the critical need for early intervention, which could prevent serious complications and improve overall healthcare efficiency by reducing hospitalizations and long-term care costs.
The Leading Choice for AS Treatment
Edwards Lifesciences has been a leader in heart valve therapy for over two decades. Since its introduction, the SAPIEN platform has become the most studied valve technology, with over one million patients treated globally. Its clinical success continues to set it apart as the go-to choice for physicians managing patients with severe AS, and this latest approval further solidifies its position as the preferred treatment option.
Larry Wood, Corporate Vice President and Group President of Transcatheter Aortic Valve Replacement and Surgical at Edwards Lifesciences, highlighted the strategic impact of the approval, saying, “This approval is a powerful opportunity to streamline patient care and improve the efficiency of the healthcare system. We are proud to partner with leading physicians to advance our knowledge of this deadly disease with high-quality science and optimize the treatment pathway for patients.”
Looking Ahead: Transforming the AS Treatment Journey
With the FDA’s approval of the SAPIEN 3 platform for asymptomatic severe AS patients, Edwards Lifesciences has paved the way for a new era of early intervention in aortic stenosis treatment. This approval represents a monumental step forward in improving patient outcomes and healthcare efficiency.
To learn more about Edwards Lifesciences and the SAPIEN 3 platform, visit www.edwards.com.