Edwards Lifesciences has shared updated findings on the safety and efficacy of the company’s RESILIA tissue aortic valve after five years of follow-up. The data was presented on Sunday, Jan. 31, at STS 2021, the 57th annual meeting of the Society of Thoracic Surgeons.
These latest findings were taken from the ongoing COMMENCE clinical trial, which was designed to focus on the outcomes of nearly 700 patients in the United States and Europe. According to Edwards, there are no signs of structural valve deterioration (SVD) in patients after five years; limiting the likelihood of SVD was one of the primary goals behind the development of RESILIA tissue.
“There continues to be a significant focus placed on tissue valve durability given the increase in life expectancy and lifestyle implications for more active patients who historically would receive mechanical valves,” Joseph E. Bavaria, MD, site principal investigator of the COMMENCE trial and vice chief of the division of cardiovascular surgery at the University of Pennsylvania, said in a prepared statement.
Bavaria, a consultant for Edwards, also noted that these latest findings “are encouraging and speak to the promise of RESILIA tissue as a significant advancement in technology for patients with valve disease.”
“Evidence from the COMMENCE trial adds to the growing body of research that demonstrates the value of innovative, RESILIA tissue-based technologies in transforming care for patients, especially more active patients,” added Daveen Chopra, corporate vice president of the Edwards surgical structural heart division.
The COMMENCE trial is scheduled to follow the health of some participants for up to 10 years.