Madrid, June 5, 2023.
Edwards Lifesciences Aortic Valve with Resilia Tissue shows favorable results in terms of durability, safety, and efficacy through data collected over seven years. The data provided encouraging results with low rates of valvular structural deterioration (99.3% absence of valvular structural deterioration), clinically stable gradients, and absence of reoperation (97.2%) over seven years.
Edwards Lifesciences has published new data from the COMMENCE aortic trial showing low rates of structural valvular deterioration in bioprosthetic aortic valves fabricated with the innovative RESILIA tissue developed by the Edwards company. The data, the longest clinical follow-up of the Edwards surgical biologic aortic valve with RESILIA tissue, with a median follow-up of 7.7 years, were presented today at the 103rd Annual Meeting of the American Association for Thoracic Surgery. Structural valve damage can be caused by calcium buildup that can affect the long-term durability of bioprosthetic valves. RESILIA Tissue Heart Valves are designed to address the calcification problems of conventional tissue valves, which may allow RESILIA valves to last longer. RESILIA tissue data collected in the COMMENCE aortic trial provided encouraging results with low rates of valvular structural deterioration (99.3% freedom from valvular structural deterioration), clinically stable gradients, and no reoperation (97.2%) over the long term. seven years old. “As biological aortic valve replacement extends to younger and more active patients, the durability of the valve becomes increasingly important,” said Manuel Castellá, Head of the Cardiovascular Surgery Service at the Hospital Barcelona Clinic. “Seven-year data from the COMMENCE aortic trial demonstrate strong clinical results and excellent durability in a study with younger patients, mean age 65.1 years.” Current technologies using this innovative tissue include the aortic valve INSPIRIS RESILIA, KONECT RESILIA Aortic Conduit Valve, MITRIS RESILIA Mitral Valve, and SAPIEN 3 Ultra RESILIA Transcatheter Aortic Heart Valve. In addition to its anti-calcifying properties, RESILIA fabric also allows the valve to be stored in dry-pack conditions, facilitating its use in the operating room.”Edwards Lifesciences is committed to developing solutions that meet the needs of patients with structural heart disease Our RESILIA tissue technology is engineered for increased durability, which contributes to improving the quality of life for patients,” said Larry Wood, Edwards corporate vice president and group president, transcatheter aortic valve replacement and surgical structural heart”. “The latest data from the COMMENCE aortic trial highlight the value of the RESILIA tissue-based offering in assisting both patients and clinicians in the management of lifelong valve disease.” The latest data from the COMMENCE aortic trial join to the growing number of clinical studies supporting the use of RESILIA tissue. The COMMENCE Aortic Trial is a prospective, nonrandomized, multicenter, single-arm Device Exemption Investigation (IDE) trial enrolling 689 patients from 27 clinical centers in the United States and Europe. The trial has evaluated the safety and efficacy of the Edwards biologic aortic valve with RESILIA tissue in patients older than 18 years with diagnosed aortic valve disease scheduled to undergo aortic valve replacement surgery. Long-term follow-up data has been collected for a subset of these patients and will continue to be evaluated for 10 years. About Edwards Lifesciences Edwards Lifesciences is the world leader in patient-centered innovations for the treatment of structural heart disease and monitoring of critical patients. They are driven by a passion for patients and are dedicated to improving lives through partnerships with physicians and stakeholders across the global healthcare landscape. For more information, visit Edwards.com, 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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