CE MARK granted for expanded indication for Sapien 3 transcatheter heart valves to cover aortic valve stenosis patients at intermediate risk.-Edwards LifeSciences

Edwards Lifesciences Corporation, announced that it has received CE Mark to expand use of the Edwards SAPIEN 3 transcatheter heart valve for the treatment of patients suffering from severe, symptomatic aortic stenosis who are at intermediate risk for open-heart surgery.

Comment:The device is already approved for this expanded indication in the US.The Sapien 3 has 70% of the TAVR market in 2015 and analysts expect the intermediate risk indication to add $400 million in annual TAVR sales.