Edwards Lifesciences hits all-time high on Sapien 3 study

Shares in Edwards Lifesciences (NYSE:EW) hit an all-time high yesterday after the company reported strong 1-year data for its Sapien 3 replacement heart valve over the weekend. Results from the Partner II trial from 1,077 intermediate-risk patients showed that the Sapien 3 beat surgical valve replacement across a variety of safety endpoints, Irvine, Calif.-based Edwards said at the American College of Cardiology’s annual meeting April 3. The combined all-cause death & disabling stroke rate was 8.4% for TAVR with Sapien 3 and 16.6% for the surgery arm, according to the study, which was also published in The Lancet. The Sapien 3 device won a nod from the FDA in June 2015 for high-risk patients. Expanding the indication to intermediate-risk patients would more than double the eligible patient pool, chairman & CEO Mike Mussallem told Reuters. That moved investors to send EW shares yesterday to an all-time high of $107.90, before the stock closed at $105.08. The Partner II data on Sapien 3 showed all-cause mortality of 7.4%, compared with 13.0% for the surgical arm. The cardiovascular death rate was 4.5% for the TAVR arm and 8.1% for the surgical arm; rates of stroke were also lower for the transcatheter group, both in terms of all strokes (4.6% for TAVR, 8.2% for surgical) and disabling stroke (2.3% to 5.9%). Analysts’ reactions were uniformly positive, which also fueled the buying. The Sapien 3 study results were as good, “if not better than an...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Cardiovascular Clinical Trials Replacement Heart Valves Wall Street Beat American College of Cardiology Conference (ACC) Edwards Lifesciences Source Type: news