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 paravalvular leak, and that its new delivery system consists of a low-profile 14-French Axela expandable sheath and an “on-balloon” design that eliminates the need for valve alignment mid-procedure.
“The Sapien 3 Ultra system incorporates enhancements to the valve, as well as a new delivery system, which are designed to further build on the exceptional outcomes of the Sapien 3 valve, which has shown extremely low rates of mortality and disabling stroke. With the Sapien 3 Ultra system, we are building on our best-in-class performance to further advance and improve patient care,” Edwards transcath heart valve corp VP Larry Wood said in a press release.
Last month, Edwards Lifesciences posted third quarter earnings that topped earnings per share consensus on Wall Street but missed on revenue expectations.