Edwards Lifesciences Corporation announced it received approval from the U.S. Food and Drug Administration (FDA) for the use of the Edwards SAPIEN 3 transcatheter valve with the Alterra adaptive prestent (SAPIEN 3 with Alterra) for patients with severe pulmonary regurgitation. The Edwards SAPIEN 3 Transcatheter Pulmonary Valve (TPV) system combines the proven 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. While pulmonic heart valve replacements represent a small fraction of the heart valve replacements done each year, it is generally required to replace valves in adolescent and adult patients suffering from Tetralogy of Fallot or other congenital heart valve defects. The Edwards 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.