Edwards Lifesciences earned a CE mark for its resilient aortic valve, the first valve that incorporates a novel tissue technology aimed at cutting down calcification that affects other valve replacements.
The Inspiris Resilia valve includes two new features: VFit technology, which is designed to allow for future valve-in-valve procedures, and the resilient bovine tissue tech, dubbed Resilia, which reduces calcification and allows the valve to be stored dry, the company said in a statement. Preclinical studies demonstrated the valve’s ability to reduce calcification and sustain blood flow.
Fighting calcification is important because it causes valve replacements to break down over time. A longer-lasting valve replacement is critical for patients who are now living longer after receiving a valve replacement as well as for younger patients receiving valve replacements. The Resilia technology not only prevents calcification once implanted in the body, but also during storage. Valves that must be stored in liquid solutions may calcify in storage, an issue that does not affect the Inspiris valve because it is stored dry.
The CE mark is based on data from a pivotal trial also conducted for U.S. premarket approval. One-year data from 673 patients showed no instances of structural valve deterioration, valve thrombosis or clotting, or nonstructural valve dysfunction, according to the statement. Three-year results from the trial will be unveiled next month.
Edwards is planning a limited launch of the device in Europe in the fourth quarter this year, with full commercialization to follow in Q1 2017. The company did not indicate plans for the U.S. market, though an FDA nod for the device is anticipated for next year. And while the CE mark is for use in the aorta, the valve is in development for mitral and pulmonary valve replacement as well.