8-Year Data Confirms Durability of Edwards’ RESILIA Tissue
Edwards Lifesciences (NYSE: EW) has announced compelling new eight-year data demonstrating that patients who received surgical aortic valves made with the company’s proprietary RESILIA™ tissue experienced significantly better long-term outcomes than those with valves made from traditional bioprosthetic materials.
For over six decades, Edwards has been a leader in heart valve innovation. The RESILIA tissue technology, developed more than 20 years ago, represents a major advancement in valve durability. It is now incorporated across a broad portfolio of Edwards’ products, including the INSPIRIS RESILIA aortic surgical valve, KONECT RESILIA aortic surgical conduit, MITRIS RESILIA mitral surgical valve, and the SAPIEN 3 Ultra RESILIA transcatheter aortic valve.
The newly released data, presented at the Heart Valve Society Annual Meeting, marks the first long-term, propensity-matched comparison between surgical valves using RESILIA tissue and those using non-RESILIA tissue. In a study involving 947 patients, results showed that RESILIA tissue significantly reduced structural valve deterioration (SVD) and the need for reoperations.
Patients with RESILIA valves had a 99.3% freedom from SVD rate after eight years, compared to 90.5% in the non-RESILIA group (p<0.0001). Similarly, freedom from reoperation due to SVD was 99.2% for RESILIA valve recipients, versus 93.9% for those with non-RESILIA valves (p=0.0007).
“These highly anticipated data provide strong clinical evidence of the excellent durability of RESILIA tissue in surgical valves,” said Dr. Tsuyoshi Kaneko, lead study author and Chief of Cardiac Surgery at Washington University in St. Louis. “This level of performance is critical to reducing reinterventions and enabling more effective lifetime management for patients.”
RESILIA tissue technology is designed to improve valve longevity by preventing calcium build-up—a primary cause of valve failure—while maintaining the strength and flexibility needed for optimal performance. The tissue undergoes a proprietary preservation process that allows it to be stored dry, simplifying logistics for healthcare providers and expanding treatment access.
Wayne Markowitz, Senior Vice President of Surgical Structural Heart at Edwards, highlighted the importance of these findings: “These data further validate the growing body of scientific evidence supporting the long-term durability, performance, and significant patient benefits of our proprietary RESILIA tissue.”
Edwards’ INSPIRIS RESILIA and SAPIEN 3 Ultra RESILIA valves are built on the proven Carpentier-Edwards PERIMOUNT platform and backed by more than 30 years of innovation and clinical validation. This platform forms the foundation for some of the most widely used heart valves in surgical and transcatheter procedures.
More than 450,000 patients around the world have received a valve with RESILIA tissue, reflecting its increasing adoption and relevance in managing structural heart disease across a broad range of patient demographics.
“With patients of all ages living longer and seeking a higher quality of life, lifetime management of heart valve disease is more important than ever,” said Larry Wood, Corporate Vice President and Group President of Transcatheter Aortic Valve Replacement and Surgical Structural Heart at Edwards. “This advancement in tissue technology reflects our ongoing commitment to developing unique innovations that improve patient outcomes.”
Edwards Lifesciences continues to invest in long-term clinical studies to further assess the durability and performance of its valve platforms. The company’s approach integrates cutting-edge science, clinical expertise, and patient-focused innovation to lead in the treatment of structural heart disease.
About Edwards Lifesciences
Edwards Lifesciences is a global leader in structural heart innovations, committed to improving the lives of patients worldwide. Through groundbreaking technologies, strong clinical evidence, and close partnerships with healthcare professionals, Edwards strives to deliver life-changing solutions for those suffering from heart valve disease and critical care conditions.
