Edwards Sapien 3 Transcatheter Pulmonary Valve With Alterra Prestent Approved by FDA

December 20, 2021—Edwards Lifesciences announced it has received FDA approval for use of the Sapien 3 transcatheter pulmonary valve (TPV) with the Alterra adaptive prestent for patients with severe pulmonary regurgitation.

The company advised that the Sapien 3 TPV system with Alterra adaptive prestent is indicated for use in 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.

According to Edwards, the Sapien 3 TPV system combines the company’s Sapien 3 transcatheter heart valve and the Alterra adaptive prestent to expand transcatheter therapy options for congenital heart valve disease patients. The Alterra prestent compensates for variations in size and morphology of the right ventricular outflow tract to provide a stable landing zone for the Sapien 3 valve.

Evan Zahn, MD, who is Director of Guerin Family Congenital Heart Program at the Smidt Heart Institute, Cedars-Sinai Medical Center in Los Angeles, California, serves as Principal Investigator for the ALTERRA clinical trial.

“The FDA approval of the Sapien 3 with Alterra is great news for patients around the world, many of whom have endured numerous surgical procedures to treat their congenital heart disease,” commented Dr. Zahn, in the Edwards press release. “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. This will result in significant improvements in quality of life and a reduction in the number of surgeries and procedures that a congenital heart patient requires over the course of their lifetime.”