Edwards' Sapien 3 Ultra TAVR System Approved in Europe

November 16, 2018—Edwards Lifesciences announced that it has received European CE Mark approval for its Sapien 3 Ultra system for transcatheter aortic valve replacement (TAVR) in patients with severe, symptomatic aortic stenosis.

According to the company, the Sapien 3 Ultra system (valve sizes 20, 23, and 26 mm) features enhancements to the valve, as well as a new delivery system and sheath. The valve features a heightened outer skirt designed to eliminate paravalvular leak. The Sapien 3 Ultra delivery system, which consists of a new low-profile 14-F Axela expandable sheath, introduces an "on-balloon" design, removing the need for valve alignment during the procedure.

John Webb, MD, commented in the announcement, "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. Webb is Director of Interventional Cardiology and Cardiac Catheterization Laboratories at St. Paul's Hospital, Vancouver, and Professor of Cardiology at the University of British Columbia in Vancouver, British, Columbia.

The Sapien 3 Ultra system will be launched in Europe as part of a controlled rollout, which includes training, to ensure high procedural success of the valve and delivery system. The company noted that the Sapien 3 Ultra system will not be launched at this time in Germany, as a result of a preliminary injunction that Boston Scientific Corporation implemented in the country.

Edwards advised that the German court will hold a full hearing on the merits of the dispute in mid 2019. The Sapien 3 and Centera valve systems remain available in Europe. The German case pertains to a European patent that Boston acquired in 2017. Finally, the company anticipates that the Sapien 3 Ultra system will receive FDA approval at approximately the end of 2018.