Sapien 3 Ultra Resilia, a transcatheter aortic valve replacement (TAVR) system, incorporates the company’s Resilia tissue technology. Edwards designed the Resilia technology to extend the valve’s durability. It utilizes bovine pericardial tissue treated with anti-calcification technology, to serve as the platform for Edwards’ new class of valves. The calcium-blocking technology addresses structural valve deterioration, a primary cause of reintervention after valve replacement.
Edwards recently launched the valve in Europe, following the September 2022 U.S. launch.
Investigators presented data at PCR London Valves 2024. They simultaneously published findings in the Journal of the American College of Cardiology (JACC): Cardiovascular Interventions.
An analysis of data from more than 9,000 propensity-matched patients in the STS/ACC TVT Registry demonstrated that those who received Edwards’ newest generation Sapien 3 Ultra Resilia valve experienced outstanding one-year outcomes that continuously surpassed recipients of the earlier generation Sapien 3 and Sapien 3 Ultra valves.
Patients receiving Sapien 3 Ultra Resilia experienced extremely low mortality, according to Edwards. Investigators also reported low reintervention rates, larger effective orifice areas, lower echo-derived gradients across all valve sizes and no paravalvular leak in 84.4% of cases.
The company reported improved results in one-year survival after TAVR compared to previous-generation valves.
“These strong, real-world data continue to demonstrate that patients treated with a Sapien valve experience excellent outcomes with rapid recovery and improved quality of life,” said Larry Wood, Edwards’ corporate VP and group president, transcatheter aortic valve replacement and surgical structural heart. “These data add to the immense body of evidence with multiple years of follow up on the Edwards Sapien valve platform and more than 10 years of clinical experience with the Resilia tissue.”
