Edwards: Sapien 3 Ultra
Edwards Lifesciences won FDA approval for its Sapien 3 Ultra transcatheter aortic valve replacement (TAVR) device in December 2018.
The device is approved for use in severe, symptomatic aortic stenosis patients for whom open-heart surgery is considered a low-risk, intermediate or greater risk, according to the company.
Sapien 3 Ultra comes in 20mm, 23mm and 26mm sizes and has an improved valve, delivery system and sheath. Its heightened outer skirt is designed to eliminate paravalvular leak and the delivery system has a low-profile 14 French Axela expandable sheath and an “on-balloon” design to eliminate the need for valve alignment mid-procedure.