DevicePMAs@therightstef:P130021_S033 JSONTXT 11 Projects

Approval for the Medtronic CoreValve System, CoreValve Evolut R System, and CoreValve Evolut PRO System. The devices are 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).