Latest-generation balloon-expandable TAVR valve now available in Europe

Edwards Lifesciences announced that the latest generation of its balloon-expandable transcatheter aortic valve replacement system has received a CE mark for use in Europe.

The valve (Sapien 3 Ultra) is indicated for patients with severe symptomatic aortic stenosis, according to a press release issued by the company.

The company stated in the release that the system includes a heightened outer skirt designed to eliminate paravalvular leak and a new delivery system featuring a low-profile 14F sheath designed to eliminate the need for in-procedure valve alignment.

“The Edwards Sapien 3 Ultra system incorporates features designed to help simplify and improve the efficiency of the procedure,” John G. Webb, MD, director of interventional cardiology and cardiac catheterization laboratories at St. Paul’s Hospital, Vancouver, and professor of cardiology at the University of British Columbia, said in the release. “This design innovation represents a meaningful advancement over previous generations of this technology.”

The valve will not yet be introduced in Germany, pending the result of a legal dispute over intellectual property in that country between Edwards and Boston Scientific, according to the release. It is not yet approved for use in the United States.

Disclosure: Webb reports he is a consultant for Edwards Lifesciences.