CORRECTING and REPLACING First All-Female TAVI Trial Shows Excellent Outcomes for Women Receiving Edwards Valves

LONDON--(BUSINESS WIRE)--Please replace the release with the following corrected version.

The updated release reads:

FIRST ALL-FEMALE TAVI TRIAL SHOWS EXCELLENT OUTCOMES FOR WOMEN RECEIVING EDWARDS VALVES

Edwards Lifesciences (NYSE: EW) today announced the results from the RHEIA Trial, a first-of-its-kind trial focused exclusively on outcomes for women receiving transcatheter aortic valve implantation (TAVI). Presenting one-year results during a Hot Line session at the ESC Congress 2024, investigators reported superior outcomes for women receiving the Edwards SAPIEN 3 or SAPIEN 3 Ultra valves as compared to those receiving surgical aortic valve replacement (SAVR).

"Women are an underrepresented group in the diagnosis and treatment of severe aortic stenosis and this landmark study provides important insights into their treatment options,” said Hélène Eltchaninoff, M.D., head of the department of cardiology at the University Hospital of Rouen. “The transcatheter and surgical arms achieved remarkable results and the performance of the transcatheter valves adds to a growing body of evidence on the treatment options available to women.”

In the evaluation of composite 1-year endpoints, TAVI was found to be superior to SAVR with 8.9% of TAVI patients experiencing death, stroke or rehospitalization versus 15.6% in the SAVR cohort. The independently run RHEIA Trial included 443 female patients with an average age of 73, randomized to TAVI or SAVR to investigate outcomes of Edwards TAVI compared to surgery in an all-comers female patient population suffering from severe symptomatic aortic stenosis. The RHEIA Trial, which was investigator initiated and supported by Edwards, was conducted across 48 sites in 12 European countries.

“We are proud of this high-quality clinical research to inform patients’ decisions about the treatment of their heart valve failure,” said Larry Wood, Edwards’ corporate vice president and group president, transcatheter aortic valve replacement and surgical structural heart. “The outstanding success of the TAVI group points to the importance of valve selection for women undergoing aortic valve replacement – especially those women with small annuli – to preserve their options for a future valve-in-valve procedure, ensuring the lifetime management of their disease.”

Correcting the valve attribution from SAPIEN 3 Ultra RESILIA to SAPIEN 3 and correcting the patient population from 440 to 443. No further corrections were made.

About Edwards Lifesciences

Edwards Lifesciences is the global leader of patient-focused innovations for structural heart disease and critical care monitoring. We are driven by a passion for patients, dedicated to improving and enhancing lives through partnerships with clinicians and stakeholders across the global healthcare landscape. For more information, visit Edwards.com and follow us on Facebook, Instagram, LinkedIn 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 Proxy Statement 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. Wood and statements regarding expected product benefits, patient outcomes, post-treatment reduction of invasive procedures, objectives and expectations 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, Edwards SAPIEN, Edwards SAPIEN 3, Edwards SAPIEN 3 Ultra, RESILIA, SAPIEN, SAPIEN 3, and SAPIEN 3 Ultra are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.