Edwards Receives Premarket Approval for Transcatheter Valve and Prestent

Edwards Lifesciences has received premarket approval from the FDA for its Sapien 3 transcatheter valve in combination with the Alterra prestent for treatment of patients with severe pulmonary regurgitation.

The prestent compensates for variations in size and morphology of the right ventricle to provide a stable landing zone for the Sapien 3 valve.

The combination will expand the range of patients who can be treated with minimally invasive therapy and will reduce “the number of surgeries and procedures that a congenital heart patient requires over the course of their lifetime," according to Evan Zahn of Cedars-Sinai Medical Center, principal investigator for a clinical trial of the Alterra prestent.