FDA Approves First Expandable Pediatric Heart Valve

The U.S. Food and Drug Administration has approved the Autus Size-Adjustable Valve by Edwards Lifesciences for pediatric patients with congenital pulmonary valve disease. The device is the first surgical heart valve designed to be expanded post-surgery using a balloon catheter to accommodate a child’s growth.

The valve can be implanted at a 13-millimeter diameter and expanded up to 22 millimeters. It utilizes polymeric leaflets rather than animal-derived tissue.