Edwards Reels in Expanded Indication for SAPIEN XT Valve

The FDA has approved the expanded use of Edwards LifeSciences Corporation’s SAPIEN CT transcatheter heart valve, designed for patients with narrowed pulmonary valves or moderate or greater pulmonary regurgitations initiated by congenital heart disease.

The valve is a minimally invasive device for patients who undergo multiple open-heart surgeries, according to Larry Wood, vice president at Edwards.

The approval was based on data pulled from Edwards’ COMPASSION trial, and extra data from Europe. — Anisa Jibrell