Edwards gains FDA approval for new Sapien 3 solution for TPV replacement
Edwards Lifesciences has received FDA approval for the use of its Sapien 3 Transcatheter Pulmonary Valve (TPV) system on patients with severe pulmonary regurgitation.
The new-look solution combines the company’s Sapien 3 transcatheter valve with the Alterra adaptive prestent. It was designed to provide improved outcomes for congenital heart valve disease patients.
“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,” Larry Wood, corporate vice president of transcatheter aortic valve replacement for Edwards, said in a prepared statement. “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.”
“The outstanding outcomes achieved by Sapien 3 with Alterra will expand the range of patients who require pulmonary valve replacement that we can now treat with minimally invasive therapy,” added Evan Zahn, MD, director of the Guerin Family Congenital Heart Program at Cedars-Sinai Medical Center’s Smidt Heart Institute and an Edwards consultant.
The Sapien 3 TPV system was designed to be used with both pediatric and adult patients who have a native or surgically repaired right ventricular outflow tract and require surgical pulmonary valve replacement.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.