DevicePMAs@therightstef:P100041_S000 JSONTXT 11 Projects

Approval for the sapien transcatheter heart valve, model 9000tfx, sizes 23mm and 26mm and accessories. This device is indicated for transfemoral delivery in patients with severe symptomatic native aortic valve stenosis who have been determined by a cardiac surgeon to be inoperable for open aortic valve replacement and in whom existing comorbidities would not preclude the expected benefit from correction of the aortic stenosis.