Sapien 3 Ultra for TAVR gets US FDA nodFebruary 4, 2019
The latest generation Sapien 3 device for transcatheter aortic valve replacement (TAVR), Ultra, got clearance from the US FDA, Edwards Lifesciences announced.
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 device was cleared for use in Europe in November last year for severe, symptomatic aortic stenosis patients. However, a patent dispute with CoreValve maker Boston Scientific has prevented a launch in Germany.
The prior generation of Sapien 3 device was approved in 2015. The original Sapien valve was first approved in 2011.