七分快三计划软件手机版式

发布时间:2020-02-24 17:14:33
Edwards gets U.S. appro

val for third generation heart valve(Reuters) - The U.S. Food and Drug Adminis

tration on Wednesday said it approved Edwards Life

sciences Corp’s Sap

ien 3 heart valve, the third-generation version of the company’s system for replacing diseased aortic valves. Edwards shares rose nearly 3 percent following the announcement. The FDA approved use of the Sapien 3 transcatheter aortic valve replacement (TAVR) system for patients not likely to survive

traditional open heart surgery and those deemed to be at high risk for death or complications wi

t

h surgery. In clinical trials, the Sapien 3, which features a smaller catheter for delivering the valv

e and an improved design to help prevent valve leakage compared with its predecessors, demonstrated ve

ry low mortality and stroke rates. TAVR systems from Edwards and rival Medtronic are increasingly being used to replac

e diseased aortic heart valves as a way to spare patients from chest-cracking open heart surgery and long recovery times. The valves are threaded into place through a blood vessel using a catheter. Newer generations of the systems appear to have addr七分快三计划软件手机版式 essed increased stroke concerns seen with the original version. “Clinical data showed that th

e Sapien 3 transcatheter heart valve is superior to the first-generation Sapien transcatheter heart valve, wit

h significantly less leakage through and around the valve,” William Maisel, acting director of the FDA’s Office of Device Evaluation, said in a statement. The Sapien 3, widely considered to be one of Edwards’ most important near-term future growth drivers, has been in use in Europe since 2014, where medical devices tend to get swifter approvals. Earlier this year,

Edwards said it hoped to gain U

.S. approval for the Sapien 3 by early 2016. The company is testing the system in lower-risk patients with the hope of eventually widening its approval. Edwards Lifesciences shares closed up $3.69, or 2.7 percent, to $141.60 on the New York Stock Exchange.