FDA Approves Transcatheter Valve With Adaptive Prestent For Pulmonary Regurgitation

US Food and Drug Administration

Today, the US Food and Drug Administration (FDA) has approved the use of the SAPIEN 3 transcatheter valve with the Alterra adaptive present for patients with severe pulmonary regurgitation.

The approval for the device was granted to Edwards Lifesciences.

The device combined the trancatherter pulmonary valve (TPV) system with the adaptive present in order to expand transcatheter therapy options for congenital heart valve disease patients. The prestent aims to compensate for variations in size and morphology of the right ventricular outflow tract to provide a stable landing zone for the valve.

In a statement, Evan Zahn, MD, Director of Guerin Family Congenital Heart Program at the Smidt Heart Institute, Cedars-Sinai Medical Center and principal investigator in the ALTERRA clinical trial, noted the decision was positive news for those who have undergone numerous surgical procedures to treat congenital heart disease.

"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,” Zahn said. “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."

Although pulmonic heart valve replacements make up a small fraction of annual heart valve replacements, it is generally required to replace valves in adolescent and adult patients suffering from Tetralogy of Fallot or any other confidential heart valve defects.

Additionally, Larry Wood, Corporate Vice President, Transcatheter Aortic Valve Replacement, Edwards Lifesciences, discussed his pride in this achievement to assist patients in living more normal lives without a surplus of invasive procedures.

"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,” he said. “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 TPV system with adaptive prestent is indicated for use in the management of pediatric and adult patients with severe pulmonary regurgitation measured by echocardiography, who have native or surgically repaired right ventricular outflow tract and are clinically indicated for surgical pulmonary valve replacement.