Eight-Year Data Confirm Long-Term Durability of Edwards’ RESILIA Tissue

CAIRO--(BUSINESS WIRE)--Edwards Lifesciences (NYSE: EW) today announced new eight-year data showing that patients receiving aortic surgical valves treated with its proprietary RESILIA tissue technology have significantly improved long-term outcomes compared to those receiving non-RESILIA tissue bioprosthetic valves.

For more than 65 years, Edwards has been the leader in heart valve innovations. To create a more durable heart valve, Edwards developed the RESILIA tissue technology more than two decades ago. Today, RESILIA tissue is used in a wide range of Edwards’ surgical and transcatheter platforms, including the INSPIRIS RESILIA aortic surgical valve, the KONECT RESILIA aortic surgical valve conduit, the MITRIS RESILIA mitral surgical valve and the SAPIEN 3 Ultra RESILIA transcatheter aortic heart valve. Edwards’ INSPIRIS RESILIA and SAPIEN 3 Ultra RESILIA valves are supported by extensive, long-term clinical evidence which is the result of three decades of innovation and expertise, leveraging the proven Carpentier-Edwards PERIMOUNT platform.

“These highly anticipated data provide strong clinical evidence of the excellent durability of RESILIA tissue in surgical valves,” said Tsuyoshi Kaneko, M.D., John M. Shoenberg Chair of Cardiovascular Disease, Chief of Cardiac Surgery at Washington University in St. Louis and lead author of the study. “This level of performance is critical to reducing reinterventions and enabling more effective lifetime management for patients.”

Presented at the Heart Valve Society Annual Meeting, the study of 947 patients marks the first long-term, propensity-matched comparison between RESILIA tissue and non-RESILIA tissue surgical aortic valves. The RESILIA tissue data from the trial reported encouraging results through eight years, with low rates of structural valve deterioration (99.3% freedom from SVD in the RESILIA tissue group versus 90.5% in the non-RESILIA tissue group, p<0.0001) and freedom from reoperation due to SVD (99.2% in the RESILIA tissue group versus 93.9% in the non-RESILIA tissue group, p=0.0007).

“These data further validate the growing body of scientific evidence supporting the long-term durability, performance and significant patient benefits of our proprietary RESILIA tissue,” said Wayne Markowitz, Edwards’ senior vice president, surgical structural heart.

To date, more than 450,000 patients worldwide have been treated with Edwards’ surgical or TAVR valves with RESILIA tissue, reflecting its expanding role in the treatment of structural heart disease.

“With patients of all ages living longer and demanding higher quality of life, the importance of lifetime management has never been greater,” said Larry Wood, Edwards’ corporate vice president and group president, transcatheter aortic valve replacement and surgical structural heart. “This significant advancement in tissue technology highlights Edwards’ dedication to pioneering unique innovations and improving patient outcomes.”

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 Messrs. Wood and Markowitz and statements regarding expected long-term patient benefits, clinical outcomes, 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.

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