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.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.