Edwards Lifesciences (NYSE: EW) welcomes the updated ESC/EACTS guidelines for valvular heart disease, which establish a simplified care pathway for all severe aortic stenosis (AS) patients, regardless of symptoms.

The guidelines enable a proactive approach to disease management and underscore that intervention should be considered for asymptomatic patients, regardless of heart function, which is a meaningful step forward from the prior practice of “watchful waiting.” The age threshold for TAVR was reduced to 70, reflecting the strong confidence in TAVR’s long-term safety, efficacy and durability.

Edwards is currently the only company with an approved TAVR indication in the US and Europe for asymptomatic severe AS. The EARLY TAVR trial played a key role in informing these guidelines updates and supporting the recent CE Mark indication for the Edwards SAPIEN 3 platform. SAPIEN 3 Ultra RESILIA offers an evidence-based option addressing durability and lifetime management. Since its introduction more than two decades ago, SAPIEN has become the most studied valve platform, with more than 1 million patients treated.

The guidelines also strengthen recommendations for transcatheter mitral and tricuspid repair and replacement therapies. In addition, Edwards presented new data today at the ESC Congress 2025 on the EVOQUE transcatheter tricuspid valve replacement (TTVR) therapy in the TRISCEND II study. The data showed that at 18 months EVOQUE significantly reduced the hard endpoint of heart failure hospitalizations with the most severe tricuspid regurgitation patients. These data also confirm that at 1-year, the EVOQUE TTVR system delivers superior clinical benefit versus medical therapy alone and consistent TR elimination. EVOQUE remains the world’s first and only approved TTVR system, approved in the US and Europe.

“These are important advancements for structural heart disease patients,” said Bernard Zovighian, CEO. “Consistent with our strategy, the combination of new clinical evidence, indication expansions and guideline changes enable improved clinical outcomes, expanded patient access and overall benefits to the healthcare system.”

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. Zovighian and statements regarding lifetime management, clinical outcomes and clinical benefits, including the consistent elimination of tricuspid regurgitation 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.

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