DevicePMAs@therightstef:P130009_S057 JSONTXT 11 Projects

Approval for the Edwards SAPIEN XT Transcatheter Heart Valve and accessories for expanding the indication to include patients with intermediate surgical risk for aortic valve replacement. The device 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 at intermediate or greater risk for open surgical therapy (i. e., predicted risk of surgical mortality >= 3% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical co-morbidities unmeasured by the STS risk calculator).