Edwards Lifesciences (NYSE:EW) said today that it won pre-market approval from the FDA for its Inspiris Resilia surgical aortic valve replacement, claiming it as “the first in a new class of resilient heart valves.”
Irvine, Calif.-based Edwards said the valve uses its Resilia tissue technology, which is designed to inhibit calcification and improve hemodynamic performance and dry storage. The company also touted Inspiris Resilia’s VFit expandable frame, which features size markers for later valve-in-valve procedures, and the underlying Carpentier-Edwards Perimount valve design.
Edwards said it’s planning for a full U.S. launch early next year for the Inspiris Resilia, which has been on the market in Europe earlier this year after winning CE Mark approval in September 2016.
“Building on Edwards’ 40 years of leadership in tissue valve technology, the Inspiris valve featuring Resilia tissue has been in development for more than a decade and may be uniquely suited for future valve-in-valve procedures,” surgical heart valve VP Bernard Zovighian said in prepared remarks. “In partnership with surgeons, Edwards is committed to continually developing transformative surgical innovations that benefit patients.”
The FDA nod was based on two-year data from the 689-patient Commence study, which Edwards said showed “no cases of structural valve deterioration, valve thrombosis or nonstructural valve dysfunction.”
“The Inspiris valve sets a new benchmark for surgical aortic valve replacement, providing patients, particularly those with active lifestyles, with a resilient tissue valve that is built on Edwards’ legacy of excellence in heart valve innovations,” added principal investigator Dr. John Puskas of the Icahn School of Medicine at New York City’s Mount Sinai hospital.
“With the addition of VFit technology, featuring the unique expandable design feature, the Inspiris valve provides an ideal foundation for heart valve patients, both now and in the future,” said Dr. Joseph Bavaria of the University of Pennsylvania.