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 li...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Cardiac Implants Cardiovascular Regulatory/Compliance Edwards Lifesciences Source Type: news