Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System - Valve-non-specific transcatheter heart valve bioprosthesis

Intended purpose

The Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a Heart Team, including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy. The Edwards SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve system is indicated for patients with symptomatic heart disease due to failing (stenosed, insufficient, or combined) of a surgical or transcatheter bioprosthetic aortic valve or surgical bioprosthetic mitral valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥ 8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical co-morbidities unmeasured by the STS risk calculator).

Functional description

The Edwards SAPIEN 3 Ultra Transcatheter Heart Valve (THV) system consists of the Edwards SAPIEN 3 Ultra THV and delivery systems. The Edwards SAPIEN 3 Ultra Valve is comprised of a balloon-expandable, radiopaque, cobalt-chromium frame, trileaflet bovine pericardial tissue valve, and polyethylene terephthalate inner and outer fabric skirts. The Commander Delivery system components are intended for use via transfemoral, subclavian/axillary access routes.