SHERIDAN, WYOMING – May 7, 2025 – Edwards Lifesciences (NYSE: EW) today unveiled new eight-year clinical data, confirming the exceptional long-term performance of its RESILIA tissue technology in aortic surgical valves. The data demonstrate significant improvements in patient outcomes, reinforcing the company's leadership in structural heart solutions.
The new findings, presented at the Heart Valve Society Annual Meeting, provide compelling evidence that patients receiving aortic surgical valves with RESILIA tissue experienced significantly better long-term outcomes compared to those with non-RESILIA tissue valves. These results highlight the value of Edwards’ innovation in delivering superior durability and performance, crucial for improving patient care and reducing the need for reoperations.
Key Findings from the Study
The study analyzed data from 947 patients and is the first long-term, propensity-matched comparison between RESILIA tissue and non-RESILIA tissue surgical aortic valves. Key results from the trial include:
- Low rates of structural valve deterioration (SVD): 99.3% of patients with RESILIA tissue experienced freedom from SVD, compared to 90.5% in the non-RESILIA group (p<0.0001).
- Freedom from reoperation due to SVD: 99.2% of patients with RESILIA tissue valves avoided the need for reoperation, compared to 93.9% in the non-RESILIA group (p=0.0007).
These findings underscore the value of RESILIA tissue in offering long-lasting solutions for patients, ultimately reducing the risk of complications and the need for costly and invasive reinterventions.
Enhanced Long-Term Patient Benefits
“These highly anticipated data provide strong clinical evidence of the excellent durability of RESILIA tissue in surgical valves,” said Dr. Tsuyoshi Kaneko, M.D., Chief of Cardiac Surgery at Washington University in St. Louis and lead author of the study. “This level of performance is critical to reducing reinterventions and enabling more effective lifetime management for patients.”
Edwards’ RESILIA technology is a cornerstone of its aortic and mitral valve offerings. It is featured in a variety of products, including the INSPIRIS RESILIA aortic surgical valve, the KONECT RESILIA aortic surgical valve conduit, and the SAPIEN 3 Ultra RESILIA transcatheter aortic heart valve. These valves benefit from more than 65 years of research, development, and clinical success, ensuring a highly durable and reliable solution for patients.
Expanding Reach and Impact
To date, over 450,000 patients worldwide have been treated with Edwards' RESILIA tissue-based heart valves, illustrating the widespread adoption and proven success of the technology. The latest findings contribute to Edwards' growing body of clinical evidence and further solidify its position as a global leader in structural heart innovations.
"With patients of all ages living longer and demanding higher quality of life, the importance of lifetime management has never been greater,” said Larry Wood, Edwards' corporate vice president and group president. “This significant advancement in tissue technology highlights Edwards’ dedication to pioneering unique innovations and improving patient outcomes.”
Looking Ahead
As Edwards Lifesciences continues to lead the charge in heart valve innovations, the company’s commitment to enhancing patient care is more evident than ever. These new eight-year data further validate the long-term value of RESILIA tissue technology and reinforce the company’s strategic focus on delivering superior, durable solutions for patients.
For more information on Edwards Lifesciences’ latest advancements, visit www.edwards.com.