The FDA approved the latest generation Sapien 3 device, Ultra, for transcatheter aortic valve replacement (TAVR), Edwards Lifesciences announced.
The approval was for treatment of severe, symptomatic aortic stenosis in patients at intermediate or greater risk of open-heart surgery.
The Ultra model comes in 20, 23, and 26 mm sizes. New features include a heightened outer skirt to reduce paravalvular leak as well as a new delivery system and 14-French Axela expandable sheath with an “on balloon” design that makes valve alignment unnecessary.
“The Edwards SAPIEN 3 Ultra system provides meaningful technology improvements that help further optimize the transcatheter aortic valve replacement procedure, adding simplicity and advancing patient care,” said John Webb, MD, of St. Paul’s Hospital in Vancouver, in a press release from Edwards.
The device was cleared for use in Europe in November for severe, symptomatic aortic stenosis patients. However, a patent dispute with CoreValve maker Boston Scientific has prevented launch in Germany.
The prior generation of Sapien 3 device was approved in 2015. The original Sapien valve was first approved in 2011.
Webb is a consultant to Edwards Lifesciences.