Edwards Lifesciences Receives FDA Approval for AUTUS Pediatric Pulmonary Valve
Edwards Lifesciences has received the U.S. Food and Drug Administration (FDA) approval for the AUTUS Size-Adjustable Valve, a surgical pulmonary valve designed specifically for pediatric patients with congenital heart disease who require pulmonary valve replacement. For many pediatric patients, pulmonary valve replacement is not a one-time event, and the AUTUS valve is the first FDA-approved surgical pulmonary valve designed for pediatric anatomy with the ability to be expanded as a child grows. Valve expansion is performed through a minimally invasive transcatheter procedure, potentially reducing the need for repeat open-heart surgeries.
FDA approval was based on the totality of clinical evidence from the pivotal study, which met its primary safety and effectiveness endpoints. All patients were free from device-related complications through 30 days and demonstrated favorable valve performance with no AUTUS valve reinterventions through six months. Among patients who completed one-year follow-up, all showed consistent outcomes, demonstrating an RVOT mean gradient of 40 mmHg or less, less than moderate pulmonary regurgitation, and no valve reinterventions. Patients will continue to be followed for 10 years. The AUTUS valve previously received FDA Breakthrough Device designation for its potential to address an important unmet need.
Dr. Emile Bacha, Surgeon-in-Chief at NewYork-Presbyterian/Columbia University Irving Medical Center and a professor of surgery at Columbia University Vagelos College of Physicians and Surgeons who was one of the investigators in the trial, said children with congenital pulmonary valve disease have long needed prosthetic valves that can account for growth over time. Bacha noted that the AUTUS valve gives congenital heart teams a new way to think about long-term care planning for pediatric patients who may otherwise face multiple surgeries.
The AUTUS valve reflects Edwards’ decades-long focus on structural heart innovation designed to address patients’ needs throughout their lives, and expands the company’s congenital treatment options, which also include SAPIEN 3, the Alterra Adaptive Prestent, and pediatric atrioseptostomy catheters.
Bernard Zovighian, CEO of Edwards, said for decades, Edwards has worked to address the needs of structural heart patients with complex conditions. Zovighian noted that the AUTUS valve represents a meaningful advancement for children who have historically had limited treatment options, and that the company’s commitment extends beyond innovation to generating clinical evidence and collaborating with physicians, medical societies, and patient groups to help address the evolving needs of patients with congenital heart disease.
