Federal Register Notice: FDA has determined the regulatory review period for Edwards Lifesciences’ Sapien Transcatheter Heart Valve is 2,473 days for extending a patent which claims the medical device. It 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. To view this notice, click here.