Edwards SAPIEN 3 TAVR Delivers Proven Long-term Benefits and Valve Performance, New Data Presented at TCT 2025

SAPIEN 3, which showed superiority at 1 year, also demonstrates compelling outcomes equivalent to surgery at seven years

Edwards Lifesciences (NYSE:EW) today announced seven-year data from the PARTNER 3 trial, reaffirming the early and sustained patient benefits of Edwards TAVR. The data, which showed superior clinical outcomes at one year, also demonstrate excellent long-term valve performance and durability. Separately, 10-year results from PARTNER 2 intermediate risk studies reinforce Edwards' leadership in setting the standard for lasting valve performance and excellent patient outcomes across all risk profiles and generations of the SAPIEN valve.

Presented during a late-breaking session at Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation, and published concurrently in The New England Journal of Medicine, the seven-year analysis marks the most extensive clinical follow-up to date for low risk transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) patients. At seven years, the data showed statistically comparable long-term valve performance between SAPIEN 3 TAVR and SAVR. Valve durability indicators remained excellent and stable over time, with no difference in bioprosthetic valve failure (6.9% vs. 7.3%) or reintervention rates (6.0% vs. 6.7%). Both all-cause and cardiovascular mortality rates were similar between cohorts. Significant improvements in health status and quality of life after treatment with SAPIEN 3 TAVR and SAVR were sustained.

"The PARTNER trials set out to determine whether TAVR could be a safe and effective, less invasive alternative to surgery," said PARTNER 3 co-principal investigator Martin Leon, M.D., professor of medicine at New York-Presbyterian Columbia University Irving Medical Center and founder and chairman emeritus of the Cardiovascular Research Foundation. "In the PARTNER 3 low risk trial, we again see the early clinical benefit of TAVR with SAPIEN 3 over surgery, as well as excellent long term valve performance and durability results for both therapies at seven years, which should be reassuring to patients and their physicians."

Also at TCT, Edwards will highlight more than a decade of research from the PARTNER Trial series, including the 10-year follow up of more than 3,000 intermediate-risk patients from PARTNER 2 and PARTNER 2 S3i. These studies also demonstrate longer-term valve performance, durability and consistent clinical outcomes of Edwards TAVR.

"Insights from the PARTNER Trial series are foundational to TAVR, inspiring confidence in the procedure, advancing the therapy and fueling structural heart innovation," said Dan Lippis, corporate vice president, transcatheter aortic valve replacement. "These latest findings reinforce the undeniable early benefits of TAVR and validate its long-term durability, matching surgery in key outcomes. As the global leader in transcatheter valve therapy, we remain committed to advancing the science of aortic valve disease – including symptomatic and asymptomatic severe stenosis as well as moderate stenosis – to transform care for patients worldwide."

Since its introduction more than two decades ago, SAPIEN has become the most studied valve platform, with more than 1 million patients treated worldwide.

Dr. Leon is a consultant to Edwards Lifesciences.

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. We intend the forward-looking statements contained in this release to be covered by the safe harbor provisions of such Acts. These forward-looking statements can sometimes be identified by the use of forward-looking words, such as "may," "might," "believe," "will," "expect," "project," "estimate," "should," "anticipate," "plan," "goal," "continue," "seek," "intend," "optimistic," "aspire," "confident" and other forms of these words and include, but are not limited to, statements made by Mr. Lippis and statements regarding clinical outcomes and long-term clinical benefits, valve durability and performance, relative valve performance and length of life 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.

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