Edwards Sapien 3 Ultra transcatheter heart valve system
Edwards Lifesciences’s Sapien 3 Ultra transcatheter heart valve system is a TAVR designed to relieve aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis.
Irvine, Calif.–based Edwards added a taller skirt to the Sapien 3 Ultra with sizes 20, 23 and 26 mm to eliminate paravalvular leak and improve TAVR outcomes. It also has an “on balloon” design that the company said does away with the need for valve alignment during the procedure. Its delivery system is compatible with its 14 Fr Axela expandable sheath.
The Sapien 3 Ultra won FDA approval in December 2018 and was a nominee in the Prix Galien best medical technology awards in 2020.