Edwards Lifesciences (NYSE:EW) announced data showing favorable safety and hemodynamic performance from its Resilia tissue platform.
Data from Edwards’ Commence clinical trial demonstrated that its bioprosthetic surgical aortic valve with the novel Resilia tissue aortic valve platform produced favorable results across a median of five years follow-up, according to a news release.
Commence is a prospective, non-randomized, multicenter, single-arm FDA investigational device exemption trial with 689 patients enrolled across 27 clinical sites in the U.S. and Europe.
The trial evaluated the Resilia tissue aortic valve in patients age 18 and older with diagnosed aortic valve disease who are scheduled to undergo aortic valve replacement surgery. The patients will continue to be evaluated through the 10-year mark.
A key safety outcome was met as there were no incidences of structural valve deterioration (SVD) at the five-year mark, as Resilia tissue is specially formulated using a proprietary integrity-preservation technology designed to potentially eliminate a key factor in calcification that leads to valve deterioration.
“Beyond the Commence study, Edwards continues to invest in research to examine different outcome measures to further validate the long-term performance and durability of Resilia tissue,” Edwards corporate VP of surgical structural heart Daveen Chopra said in the release. “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.”