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Edwards Lifesciences (NYSE: EW) announced 10-year results from the COMMENCE aortic trial, highlighting long-term durability and sustained performance of its RESILIA tissue. The data were presented at the 106th Annual Meeting of the American Association for Thoracic Surgery.
With evidence increasingly supporting earlier intervention in the valve disease pathway, Edwards said durable valve solutions remain a key need. The COMMENCE trial provides prospective, 10-year data intended to demonstrate the durability of RESILIA tissue and its role in “lifetime management” for patients with aortic stenosis.
Edwards also noted that more than 500,000 patients worldwide have been treated with Edwards’ surgical and transcatheter innovations featuring RESILIA tissue.
At 10 years, COMMENCE trial data for patients treated with Edwards’ surgical valves featuring RESILIA tissue showed:
The company also reported sustained hemodynamic performance, including stable gradients and effective orifice area over time.
Edwards said long-term durability can reduce the likelihood of repeat procedures over a patient’s lifetime, helping preserve quality of life as life expectancy increases.
“These 10-year data from the COMMENCE trial suggest this tissue technology has the potential to change the way we think about durability in biological valves, including in younger patients,” said Lars G. Svensson, MD, PhD, chief of the Sydell and Arnold Miller Family Heart, Vascular & Thoracic Institute and professor of surgery at Cleveland Clinic. “What is striking is the low rate of structural valve deterioration and need for reoperation, even though the trial enrolled younger patients who historically face higher risks of valve deterioration, underscoring the importance of long-term evidence when physicians are making treatment decisions with their patients.”
Edwards said it has led structural heart innovation for nearly 70 years, including evidence generation used to set standards for evaluating valve performance, durability, and treatment options in severe aortic stenosis. The COMMENCE trial was described as building on Edwards’ broader clinical evidence, including the PARTNER series of trials, which reported 10-year follow-up outcomes for SAPIEN TAVR and SAVR.
RESILIA tissue was designed to enhance the durability of tissue valves by helping resist calcification, which Edwards identified as a leading cause of valve failure over time. The technology combines advanced calcium blocking processes with dry storage to support long-term valve performance.
“As patients live longer and expect to remain active, structural heart therapies must be designed with lifetime care in mind,” said Bernard Zovighian, Edwards’ CEO. “The COMMENCE 10-year study is the latest addition to our breadth of long-term data reflecting our commitment to advancing durable valve technologies through continuous evidence development, so Heart Teams and patients can make informed decisions over time.”
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. Edwards said safety endpoints were defined according to established guidelines and independently adjudicated.
Edwards Lifesciences describes itself as a global structural heart innovation company focused on improving patient lives through technologies, evidence, and partnerships with clinicians and healthcare stakeholders.
The company’s release includes forward-looking statements under the Securities Act of 1933 and the Securities Exchange Act of 1934, including statements about expected long-term durability and sustained performance, reduction in the likelihood of repeat procedures, and other expectations that are not historical facts. Edwards said such statements are based on management estimates and assumptions and are inherently uncertain.
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