Edwards Lifesciences wins CE Mark for Inspiris Resilia aortic valve

Edwards Lifesciences (NYSE:EW) said today it won CE Mark approval in the European Union for its Inspiris Resilia aortic valve.

The Irvine, Calif.-based company said the valve is the 1st in a “new class of resilient heart valves” which incorporate its Resilia tissue and features a Perimount Magna ease valve and VFit technology for future valve-in-valve procedures.

“The Inspiris valve creates a new class of surgical valves and includes key patient-focused innovations, such as the resilient tissue and the VFit technology, to advance the treatment of patients with heart valve disease. In partnership with surgeons, Edwards is committed to developing differentiating technologies that set a new standard for surgical heart valves,” surgical heart valve therapy corp veep Bernard Zovighian said in a press release.

The company touted its Resilia tissue as a 1st-of-its-kind tissue platform designed with improved anti-calcification properties and sustained hemodynamic performance.

European approval of the valve was obtained with support from the company’s Commence pivotal trial, Edwards said, which reported no cases of structural valve deterioration, valve thromboses or nonstructural valve dysfunction at 1-year. Data from separate pre-clinical studies indicated significantly reduced calcification and sustained hemodynamics compared with current treatment options, Edwards said.

“Heart valve patients are living longer and want to maintain their active lifestyles. The Inspiris valve provides surgeons and their patients with an advanced treatment option that represents an ideal foundation for the future treatment of heart valve patients,” Dr. Vinayak Bapat of London’s Guy’s and St. Thomas’ Hospital said in prepared remarks.

Edwards said it is planning a targeted commercial release of the valve in Europe in the 4th quarter of this year, with a full launch in the 1st quarter of 2017.

Earlier this month, Edwards Lifesciences said it won CE Mark approval in the European Union for an expanded indication for its Sapien 3 transcatheter aortic valve replacement.

The expanded indication covers patients at intermediate risk for open heart surgery, Irvine, Calif.-based Edwards said. Last month the FDA also expanded the Sapien 3 indication to include intermediate-risk aortic stenosis patients. The device won its original CE Mark approval back in January 2014, with the U.S. federal safety watchdog following suit in June 2015.

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