Additional Relevant Details 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.


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.