Edwards Lifesciences (NYSE:EW) said today that it won FDA approval for the use of its Sapien XT replacement heart valve in adult and pediatric patients with conditions affecting their pulmonary valves.
The Sapien XT device is already approved in the U.S. for transcatheter aortic valve replacement in inoperable and high-risk patients with severe symptomatic stenosis and for valve-in-valve procedures in high-risk patients.
The new approval expands the indication for Sapien XT to pulmonary valve replacement procedures, the Irvine, Calif.-based company said.
“U.S. approval of the Sapien XT valve for pulmonic procedures provides an important, minimally invasive treatment option for a small group of patients who typically face the burden of multiple open-heart surgeries, oftentimes beginning at birth or during childhood. As risks increase with each open-heart surgery, a non-surgical option can help them receive treatment, recover and return to normal activities sooner,” transcatheter heart valves president Larry Wood said in prepared remarks.
Edwards said the new FDA approval was backed by data from its Compassion trial and other data from European studies.
