FDA Approves SAPIEN 3 with Alterra from Edwards Lifesciences Corporation

The US Food and Drug Administration has approved the Edwards SAPIEN 3 transcatheter valve with the Alterra adaptive present for patients with severe pulmonary regurgitation, according to a statement from Edwards Lifesciences Corporation.

The approval of the Sapien 3 with Alterra, which was announced on December 20, is for 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.

"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," said Evan Zahn, MD, director of the Guerin Family Congenital Heart Program at the Smidt Heart Institute at Cedars-Sinai Medical Center and principal investigator for the ALTERRA clinical trial, in the aforementioned statement. "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."

According to Edwards Lifesciences Corporation, the SAPIEN 3 Transcatheter Pulmonary Valve system combines the SAPIEN 3 transcatheter heart valve and the Alterra adaptive prestent to further expand transcatheter therapy options for patients with congenital heart valve disease. The release from Edwards Lifesciences Corporation also noted it is generally required to replace valves in adolescent and adult patients suffering from Tetralogy of Fallot or other congenital heart valve defects.

"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," said Larry Wood, corporate vice president of transcatheter aortic valve replacement at Edwards Lifesciences Corporation. "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."

For more on the SAPIEN 3 transcatheter heart valve check out Edwards Lifesciences Corporation website.