Edwards Lifesciences (NYSE:EW) announced today that it received FDA approval for the use of its Sapien 3 transcatheter valve with the Alterra adaptive prestent.
Irvine, California-based Edwards garnered the FDA nod for use of the Sapien 3 with Alterra for patients with severe pulmonary regurgitation.
The Sapien 3 transcatheter pulmonary valve (TPV) system combines the Sapien 3 valve and the Alterra adaptive present to expand transcatheter therapy options for congenital heart valve disease patients, Edwards said in a news release. The company designed Alterra to compensate for variations in size and morphology of the right ventricular outflow tract to provide a stable landing zone for the Sapien 3 valve.
Indication for the Edwards Sapien 3 TPV system with Alterra covers the management of pediatric and adult patients with severe pulmonary regurgitation as measured by echocardiography, who have a native or surgically repaired right ventricular outflow tract and are clinically indicated for surgical pulmonary valve replacement.
“I’m very proud of this advancement, which exemplifies the important work of our team at Edwards to develop life-saving innovations addressing urgent needs of this important patient group,” Edwards Corporate VP for Transcatheter Aortic Valve Replacement Larry Wood said in the release. “Many of these patients endure repeated open-heart surgeries to address heart conditions present since birth, which takes a huge toll on their ability to lead normal lives. The Sapien 3 with Alterra provides a new treatment option that can reduce the number of invasive procedures these patients face in their lifetimes.”