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Published on 05/02/2026 at 12:50 pm EDT
Edwards Lifesciences announced 10-year results from the COMMENCE aortic trial, reinforcing the long-term durability and sustained performance of its proprietary RESILIA tissue. The COMMENCE trial provides prospective, 10-year data demonstrating the durability of Edwards? RESILIA tissue and its role in lifetime management for patients with aortic stenosis.
To date, more than 500,000 patients worldwide have been treated with Edwards? surgical and transcatheter innovations featuring RESILIA tissue. At 10 years, COMMENCE trial data showed that patients treated with Edwards?
surgical valves featuring RESILIA tissue experienced: 97.9% freedom from structural valve deterioration (SVD), 97.8% freedom from reoperation due to SVD, 98.6% freedom from non-structural valve dysfunction (other than PVL), sustained hemodynamic performance, including stable gradients and effective orifice area over time. The COMMENCE trial builds on the totality of Edwards? clinical evidence, reinforcing the durability of outcomes supporting its surgical and transcatheter therapies, including large, randomized, FDA-approved studies such as the PARTNER series of trials.
The PARTNER trial series advanced the field with long-term patient outcomes on treatment with SAPIEN TAVR and SAVR, with 10 years of follow-up data. The new COMMENCE trial data build on that foundation with the latest evidence on the long-term durability of RESILIA tissue. RESILIA tissue was designed to enhance the durability of tissue valves by helping resist calcification, a leading cause of valve failure over time.
The technology combines advanced calcium blocking processes with dry storage to support long-term valve performance. The COMMENCE aortic trial is an FDA-approved, pivotal, prospective, multicenter clinical study designed to evaluate the safety and effectiveness of a bioprosthetic valve with RESILIA tissue used in SAVR, with follow-up through 10 years. Safety endpoints were defined according to established guidelines and independently adjudicated.