Edwards Lifesciences: Edwards' Aortic Valve With Resilia Tissue Shows Favorable Durability, Safety and Efficacy Outcomes in Seven Year Data

Edwards Lifesciences announced new data from the COMMENCE aortic trial, demonstrating low rates of structural valve deterioration (SVD) in bioprosthetic aortic valves with the company's innovative RESILIA tissue. The data, which represent the longest clinical follow-up for Edwards' bioprosthetic surgical aortic valve with RESILIA tissue with a mean follow-up of 7.7 years, were presented today at the 103^rd annual meeting of the American Association for Thoracic Surgery.

SVD can be caused by a buildup of calcium that may impact long-term durability of bioprosthetic valves. Heart valves with RESILIA tissue are designed to address calcification challenges of conventional tissue valves, potentially allowing valves with RESILIA to last longer. The RESILIA tissue data from the COMMENCE aortic trial reported encouraging results with low rates of SVD (99.3% freedom from SVD), clinically stable gradients and freedom from reoperation (97.2%) through seven years.

It is encouraging to see the strong clinical outcomes and excellent durability data from the seven-year data of the COMMENCE aortic trial on younger patients with a mean age of 65.1 years" said Gianluca Lucchese, Consultant Cardiac Surgeon, Guy's and St Thomas' NHS Foundation Trust. Valve durability keeps improving with latest innovative technologies. This is a significant progress as more and more younger and active patients undergo bioprosthetic aortic valve replacement

Current technologies utilizing this novel tissue include the INSPIRIS RESILIA aortic valve, the KONECT RESILIA* aortic valved conduit, the MITRIS RESILIA* mitral valve and the SAPIEN 3 Ultra RESILIA* transcatheter aortic heart valve. 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.

"Edwards Lifesciences is committed to addressing the needs of patients with structural heart disease and our RESILIA tissue technology is designed for enhanced durability, supporting patients' improved quality of life," said Larry Wood, Edwards' corporate vice president and group president, transcatheter aortic valve replacement and surgical structural heart. "The latest COMMENCE aortic trial data emphasizes the value of RESILIA tissue-based offerings in helping patients and their physicians with lifetime management of valve disease."

The latest data from the COMMENCE aortic trial join a growing library of clinical studies in support of RESILIA tissue.

The COMMENCE aortic trial 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 is evaluating the safety and effectiveness of Edwards' bioprosthetic aortic valve with RESILIA tissue in patients ages 18 and older with diagnosed aortic valve disease and scheduled to undergo aortic valve replacement surgery. Long-term follow-up data were collected in a subset of these patients and will continue to be evaluated through 10 years.

Gianluca Luccheseis a consultant to Edwards Lifesciences.

At this time the following devices KONECT RESILIA, MITRIS RESILIA and the SAPIEN 3 Ultra RESILIA are not CE marked

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 https://www.edwards.com/gb and follow us on LinkedIn and Twitter.

Edwards, Edwards Lifesciences, and the stylized E logo, COMMENCE, INSPIRIS, INSPIRIS RESILIA, KONECT, KONECT RESILIA, MITRIS, MITRIS RESILIA, SAPIEN and RESILIA are trademarks and service marks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.

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