Edwards RESILIA Tissue Aortic Valve Demonstrates Favorable Safety and Efficacy at Five Years

AUSTIN, Texas, Jan. 31, 2021 /PRNewswire/ -- Edwards Lifesciences (NYSE: EW) today announced new data from the COMMENCE clinical trial that demonstrate Edwards' bioprosthetic surgical aortic valve with the company's novel RESILIA tissue platform show favorable safety and hemodynamic performance through a median of five years follow-up. The data were presented at the 57th annual meeting of the Society of Thoracic Surgeons.

"There continues to be a significant focus placed on tissue valve durability given the increase in life expectancy and lifestyle implications for more active patients who historically would receive mechanical valves," said Joseph E. Bavaria, M.D., lead enroller and site principal investigator for the COMMENCE study and the Brooke Roberts-William M. Measey professor of surgery and vice chief of the division of cardiovascular surgery, University of Pennsylvania. "The latest data from the COMMENCE study are encouraging and speak to the promise of RESILIA tissue as a significant advancement in technology for patients with valve disease."

There were no incidences of structural valve deterioration (SVD) at the five-year review mark, a key safety outcome. SVD can be caused by a buildup of calcium on the valve's tissue or by other damage that impacts long-term durability of the valve. RESILIA tissue is specially formulated using a proprietary integrity-preservation technology that may eliminate a key factor in calcification leading to valve deterioration.

"Beyond the COMMENCE study, Edwards continues to invest in research to examine different outcome measures to further validate the long-term performance and durability of RESILIA tissue," said Daveen Chopra, Edwards' corporate vice president, surgical structural heart. "Evidence from the COMMENCE trial adds to the growing body of research that demonstrates the value of innovative, RESILIA tissue-based technologies in transforming care for patients, especially more active patients."

Current technologies utilizing this novel tissue include the INSPIRIS RESILIA aortic valve and the KONECT RESILIA aortic valved conduit, the first ready-to-implant solution for bio-Bentall procedures. In addition to its anti-calcification properties, RESILIA tissue also allows the valve to be stored under dry packaging conditions, facilitating ease of use in the operating room.

The COMMENCE study is a prospective, non-randomized, multicenter, single-arm investigational device exemption (IDE) trial comprised of 689 patients at 27 clinical sites across the United States and Europe. The trial evaluated the safety and effectiveness of Edwards' RESILIA tissue aortic valve in patients ages 18 and older with diagnosed aortic valve disease and scheduled to undergo aortic valve replacement surgery. Data were collected for a total of five years and a subset of these patients will continue to be evaluated through 10 years. At this stage, the study has recorded data equivalent to 2,989 patient-years of follow-up.

Additional RESILIA tissue studies include:

• European feasibility study: a prospective, single-arm observational clinical trial that evaluated SVD in a cohort of 133 patients. There were no events of structural valve deterioration throughout the study period of five years.
• RESILIENCE clinical trial: an ongoing, first-of-its-kind study designed to assess calcium deposits as a way to potentially predict long-term bioprosthetic valve durability. The study will enroll up to 250 patients under the age of 65 at the time of surgery to examine incidence of valve deterioration from year five to 11 after surgery.

Dr. Bavaria is a consultant to Edwards Lifesciences.

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, Twitter and YouTube.

This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements include, but are not limited to statements made by Dr. Bavaria and Mr. Chopra and statements regarding expected product benefits, patient outcomes, future plans related to the product lines, 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 including its Annual Report on Form 10-K for the year ended December 31, 2019 and the Quarterly Report on Form 10-Q for the quarter ended March 31, 2020. These filings, along with important safety information about our products, may be found at edwards.com.

Edwards, Edwards Lifesciences, the stylized E logo, Edwards RESILIA, COMMENCE, INSPIRIS, INSPIRIS RESILIA, and KONECT are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners. This statement is made on behalf of Edwards Lifesciences Corporation and its subsidiaries.

SOURCE Edwards Lifesciences Corporation

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