FDA Approves AUTUS Size-Adjustable Pulmonary Valve for Pediatric Congenital Heart Disease – Edwards Lifesciences
Edwards Lifesciences announced that the U.S. Food and Drug Administration (FDA) has approved 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. 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.
“Children with congenital pulmonary valve disease have long needed prosthetic valves that can account for growth over time. 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.” – 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.
FDA approval of the Autus valve was based on the totality of clinical evidence from the pivotal study. The study met its primary safety and effectiveness endpoints, with 100% of patients free from device-related complications through 30 days and demonstrating favorable valve performance with no Autus valve reinterventions through six months. Among patients who completed one-year follow-up, 100% 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.
The Autus valve reflects Edwards’ decades-long focus, commitment and leadership in structural heart innovation designed to address patients’ needs throughout their lives. The Autus valve provides an important opportunity to support pediatric patients with congenital heart disease. This approval expands Edwards’ congenital treatment options, which also include Sapien 3, the Alterra Adaptive Prestent and pediatric atrioseptostomy catheters.
“For decades, Edwards has worked to address the needs of structural heart patients with complex conditions. The Autus valve represents a meaningful advancement for children who have historically had limited treatment options. Our 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.” – Bernard Zovighian, Edwards’ CEO.
