CE Mark for SAPIEN 3 Ultra system for transcatheter aortic valve replacement.- Edwards Lifesciences .

Edwards Lifesciences Corporation announced it has received CE Mark for the SAPIEN 3 Ultra system for transcatheter aortic valve replacement in severe, symptomatic aortic stenosis patients. As previously announced, Edwards will introduce the SAPIEN 3 Ultra system in Europe as part of a controlled rollout, which includes training, to ensure high procedural success of this advanced valve and delivery system.The SAPIEN 3 Ultra system will not be launched at this time in Germany, as a result of the preliminary injunction that Boston Scientific chose to implement in the country.

Edwards is disappointed in Boston Scientific's tactic to limit access of this new therapy. The German court will hold a full hearing on the merits of the dispute in mid-2019, and Edwards continues to believe that it will ultimately prevail in this matter. The SAPIEN 3 and CENTERA valve systems remain available in Europe. The German case pertains to a European patent that Boston acquired in 2017 (No. EP 2 949 292).

The SAPIEN 3 Ultra system is not approved in the United States; Edwards previously discussed that it anticipates it will receive FDA approval for the SAPIEN 3 Ultra system around the end of 2018.

The Edwards SAPIEN 3 Ultra system (valve sizes 20, 23 and 26mm) features enhancements to the valve, and 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-French Axela expandable sheath, introduces an "on balloon" design, removing the need for valve alignment during the procedure.