Edwards LifeSciences Edwards SAPIEN 3 Ultra System – Edwards Commander Kit

• The Edwards SAPIEN 3 Ultra 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 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).