Edwards’ Structural Heart Leadership Demonstrated Through Expanding Body of Scientific Evidence at New York Valves

NEW YORK--(BUSINESS WIRE)--Edwards Lifesciences (NYSE: EW) today announced new data presented at New York Valves 2026, the annual conference organized by the Cardiovascular Research Foundation, which reinforce the company's leadership in advancing high-quality scientific evidence and innovating for patients. These new data – spanning aortic, mitral and tricuspid therapies – provide further understanding of the complexity of structural heart disease and the need for innovative treatment options.

Ahead of the planned full clinical presentation at TCT later this year, the baseline characteristics of the PROGRESS trial presented today provide new insights into the heterogeneous nature of moderate aortic stenosis (AS) patients. Research has shown that approximately half of moderate AS patients present with at least one at-risk feature, which includes symptoms, progressive cardiac damage, declining health and elevated risk of hospitalization. The PROGRESS trial is designed to evaluate whether patients with moderate AS and at least one risk factor may benefit from transcatheter aortic valve replacement (TAVR) earlier than current guidelines, which recommend clinical surveillance with echocardiographic follow-up every 1-2 years. Details of the PROGRESS trial design were recently published in the American Heart Journal and baseline characteristics of the PROGRESS trial are listed below:

• More than 95% were symptomatic
• More than 70% had 2 or more at-risk features
• More than 90% had a normal left ventricular function
• Mean age was 78 ± 6 years
• Mean KCCQ score was 64 ± 24
• Broad surgical risk distribution (46% low risk)

Additional late-breaking clinical science presentations strengthen the evidence base for the SAPIEN 3 platform, including seven-year benchmark durability data from the PARTNER 3 trial, simultaneously published in JAMA Cardiology. Also presented were new findings from the EARLY TAVR trial, reinforcing the shift toward proactive disease management and providing continued long-term reassurance for physicians and patients. These data on Edwards’ SAPIEN platform underscore the benchmark valve performance and differentiated long-term durability of the therapy.

“Edwards remains focused on addressing the significant unmet needs of the many structural heart patients who remain untreated today,” said Bernard Zovighian, Edwards’ CEO. “Our expanding evidence base reflects Edwards’ clear and sustained commitment to advancing care through partnership with the physician community. From building a deeper understanding of the moderate AS population and advancing evidence about asymptomatic patients to demonstrating distinguished SAPIEN platform durability and strategies for lifetime disease management, we are strengthening confidence in long-term outcomes and increasing access for patients worldwide.”

Also at the meeting, new data highlighted clinical trial and real-world outcomes across Edwards’ mitral and tricuspid portfolio. Data from more than 4,500 patients treated with the PASCAL system in the STS/ACC Transcatheter Valve Therapy Registry helps highlight the sustained safety and effectiveness of the technology for patients with mitral regurgitation (MR). One-year data from the ENCIRCLE trial Mitral Annular Calcification (MAC) Registry support the safety, effectiveness and quality of life improvements with SAPIEN M3, the first and only transcatheter transseptal mitral valve replacement system, in patients with symptomatic valve dysfunction associated with MAC who are deemed unsuitable for surgery or TEER therapy by a heart team.

Zovighian added, “Together, our differentiated technology and world-class evidence reflect Edwards’ leadership in elevating the standard of care for structural heart patients and improving outcomes across the care continuum.”

About Edwards Lifesciences

Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most. Discover more at www.edwards.com and follow us on LinkedIn, Facebook, Instagram and YouTube.

This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include, but are not limited to, statements made by Mr. Zovighian and statements regarding the benchmark performance and differentiated long-term durability of Edwards’ SAPIEN platform, elevating the standard of care, our leadership in advancing our growing body of high-quality scientific and clinical evidence, long-term reassurance for physicians and patients, our commitment to advance care through partnerships with the physician community, strengthen confidence in long-term outcomes and expanding access for patients, innovating for patients with structural heart disease, the safety and effectiveness and quality of life improvements of our products, and improving outcomes across the care continuum, and other statements that are not historical facts. Forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though they are inherently uncertain and difficult to predict. Our forward-looking statements speak only as of the date on which they are made, and we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement. Investors are cautioned not to unduly rely on such forward-looking statements.

Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those expressed or implied by the forward-looking statements based on a number of factors as detailed in the company's filings with the Securities and Exchange Commission. These filings, along with important safety information about our products, may be found at Edwards.com.

Edwards, Edwards Lifesciences, the stylized E logo, EARLY TAVR, ENCIRCLE, PARTNER, PARTNER 3, PASCAL, PROGRESS, SAPIEN, SAPIEN 3 and SAPIEN M3 are trademarks of Edwards Lifesciences Corporation or its affiliates. All other trademarks are the property of their respective owners.