Edwards’ SAPIEN 3 Ultra RESILIA Valve Demonstrates Continued Excellent Outcomes for Patients in Real World Data

Edwards Lifesciences (NYSE: EW) today announced one-year data highlighting the continued outstanding performance of its SAPIEN 3 Ultra RESILIA valve. The data were presented at PCR London Valves 2024 and simultaneously published in the Journal of the American College of Cardiology (JACC): Cardiovascular Interventions.

An analysis of data from more than 9,000 propensity-matched patients in the STS/ACC TVT Registry¹ demonstrated that those who received Edwards’ newest generation SAPIEN 3 Ultra RESILIA valve experienced outstanding one-year outcomes that continuously surpassed recipients of the earlier generation SAPIEN 3 and SAPIEN 3 Ultra valves. Patients receiving the SAPIEN 3 Ultra RESILIA valve experienced extremely low mortality, low rates of reintervention, larger effective orifice areas, lower echo-derived gradients across all valve sizes and no paravalvular leak in 84.4% of cases.

“These strong, real-world data continue to demonstrate that patients treated with a SAPIEN valve experience excellent outcomes with rapid recovery and improved quality of life,” said Larry Wood, Edwards’ corporate vice president and group president, transcatheter aortic valve replacement and surgical structural heart. “These data add to the immense body of evidence with multiple years of follow up on the Edwards SAPIEN valve platform and more than 10 years of clinical experience with the RESILIA tissue.”

Patients in the SAPIEN 3 Ultra RESILIA valve cohort, who had an average STS score of 3.6 and average age of 77, experienced meaningful quality of life benefits with a clinically significant average 31-point increase in KCCQ² score and one-day length of hospital stay with 93% discharged to their homes.

"This is the first large-population study that showed the latest generation SAPIEN 3 Ultra RESILIA valve results in improved 1-year survival after TAVR versus prior generation valves, given it reduces mild or greater paravalvular leak,” said Gilbert Tang, MD, MSc, MBA, Surgical and Academic Director of the Structural Heart Program for the Mount Sinai Health System and Professor and Vice-Chair of Innovation in Cardiovascular Surgery at the Icahn School of Medicine at Mount Sinai. “This finding particularly affected low surgical risk patients, where the impact would matter more because of their longer life expectancies.”

Dr. Tang is a consultant for Edwards Lifesciences.

¹ The STS/ACC TVT Registry is a collaboration between the Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC).

² The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item survey that measures the impact of heart failure on a patient's quality of life, symptoms, and physical function.

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. Wood and statements regarding expected patient outcomes and product benefits, performance of the technologies, 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.

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