Edwards Releases 7-Year Resilia Aortic Valve Data

Edwards Lifesciences released new data from its COMMENCE aortic trial that demonstrated low rates of structural valve deterioration (SVD) in bioprosthetic aortic valves using its Resilia tissue.
 
The data represented the longest clinical follow-up for Edwards’ bioprosthetic surgical aortic valve with Resilia tissue with mean follow-up of 7.7 years. 689 patients were in the investigational device exemption (IDE) trial at 27 sites in the U.S. and Europe. The trial is evaluating safety and effectiveness of Edwards’ bioprosthetic aortic valve with Resilia tissue in adult patients with diagnosed aortic valve disease and scheduled to undergo aortic valve replacement surgery.
 
Long-term follow-up data will continue to be evaluated through 10 years.
 
SVD can occur due to a buildup of calcium that can affect bioprosthetic valves’ long-term durability. Heart valves with Resilia tissue are engineered to address conventional tissue valves’ calcification changes. COMMENCE aortic trial data showed 99.3% freedom from SVD, clinical stable gradients, and 97.2% freedom from operation through seven years.
 
“As bioprosthetic aortic valve replacement extends to younger and more active patients, valve durability is becoming increasingly important,” Thomas Beaver, M.D., Grant and Shirle Herron Chair, Professor and Chief of Cardiovascular Surgery, University of Florida College of Medicine, told the press. “The seven-year data from the COMMENCE aortic trial demonstrates strong clinical outcomes and excellent durability in a study of younger patients with a mean age of 65.1 years.”
 
The Resilia tissue is used in the Inspiris Resilia valve, Konect Resilia aortic valved conduit, Mitris Resilia mitral valve, and Sapien 3 Ultra Resilia transcatheter aortic heart valve. Resilia also lets the valve be stored under dry packaging conditions to facilitate ease of use in the operating room.
 
“Edwards Lifesciences is committed to addressing the needs of patients with structural heart disease and our RESILIA tissue technology is designed for enhanced durability, supporting patients’ improved quality of life,” said Larry Wood, Edwards’ corporate vice president and group president, transcatheter aortic valve replacement and surgical structural heart. “The latest COMMENCE aortic trial data emphasizes the value of RESILIA tissue-based offerings in helping patients and their physicians with lifetime management of valve disease.”