December 28, 2011 – Edwards Lifesciences announced two-year results of a pivotal clinical study of inoperable patients with severe aortic stenosis treated with the Edwards Sapien transcatheter heart valve, which was approved in November by the U.S. Food and Drug Administration (FDA). These data from The PARTNER Trial (Cohort B) demonstrated a widening survival benefit for Sapien valve patients at two years, including significantly less time spent in the hospital.
