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

Intended purpose

The Edwards SAPIEN 3 Ultra RESILIA transcatheter heart valve system is indicated for use in patients with heart disease due to native calcific aortic stenosis at any or all levels of surgical risk for open heart surgery. The Edwards SAPIEN 3 Ultra RESILIA transcatheter heart valve system is indicated for patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of an aortic transcatheter bioprosthetic or surgical aortic or mitral bioprosthetic 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 RESILIA (S3UR) transcatheter heart valve (THV) system consists of the S3UR THV and Delivery System. The THV is comprised of a balloon-expandable, radiopaque, cobaltchromium frame, trileaflet RESILIA bovine pericardial tissue valve, and polyethylene terephthalate (PET) inner and outer fabric skirts. The DS and accessories are intended to facilitate the placement of the bioprosthesis via the transfemoral, transseptal, subclavian/axillary access approaches.