FDA approves Sapien XT transcatheter heart valve for pulmonic valve replacement procedures- Edwards Lifesciences

Edwards Lifesciences has announced FDA approval to expand use of the Edwards Sapien XT transcatheter heart valve for pulmonic valve replacement procedures. The approval enables the treatment of adult and pediatric patients who suffer from either a narrowed pulmonary valve or moderate or greater pulmonary regurgitation caused by congenital heart disease.

FDA approval of the Edwards Sapien XT valve for pulmonic procedures was supported by data from the multicenter COMPASSION clinical trial and additional clinical data from Europe. As previously indicated, the commercial opportunity related to this approval is small and is factored into 2016 financial expectations.

Comment: The Sapien XT valve was approved by the FDA in June 2014 for patients at high risk for native aortic valve replacement surgery, and received CE Mark for valve-in-valve procedures in early 2014.