Edwards Lifesciences wins CE Mark for Sapien 3 Ultra TAVR

Edwards Lifesciences (NYSE:EW) said today it won CE Mark approval in the European Union for its Sapien 3 Ultra transcatheter aortic valve replacement system intended for patients with severe, symptomatic aortic stenosis. Despite winning a CE Mark, Edwards said that the new valve will not be launched in Germany due to a preliminary injunction from rival Boston Scientific (NYSE:BSX). The company said that “the German court will hold a full hearing on the merits of the dispute” mid-next year, and that it is hopeful it will prevail. The company said it will introduce the Sapien 3 Ultra in the rest of Europe as part of a controlled rollout, including training intended to raise procedural success with the system. Edwards added that it is hopeful it will receive FDA clearance for the Sapien 3 Ultra by the end of this year. “The Edwards Sapien 3 Ultra system incorporates features designed to help simplify and improve the efficiency of the procedure. This design innovation represents a meaningful advancement over previous generations of this technology,” Dr. John Webb of Vancouver’s St. Paul’s Hospital and the University of British Columbia said in a prepared statement. The newly cleared Sapien 3 Ultra comes in 20mm, 23mm and 26mm sizes and features an improved valve, delivery system and sheath, the Irvine, Calif.-based company said. Edwards said that the Sapien 3 Ultra is designed with a heightened outer skirt intended to eliminate paravalvula...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiac Implants Cardiovascular Featured Regulatory/Compliance Replacement Heart Valves Edwards Lifesciences Source Type: news