Edwards Lifesciences Receives FDA Approval for AUTUS Valve, the First Surgical Pulmonary Valve for Pediatric Patients
Business Wire•01/10/2026•16:26 ET
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Key Highlights
- ➤FDA approves Edwards Lifesciences (EW) AUTUS Size-Adjustable Valve for pediatric pulmonary replacement
- ➤AUTUS is the first FDA-approved surgical pulmonary valve designed for pediatric anatomy
- ➤Valve expands through a minimally invasive transcatheter procedure as children grow
- ➤Pivotal study showed 100% freedom from device-related complications through 30 days
- ➤One-year follow-up showed favorable valve performance with no reinterventions
Expert Statements
Emile Bacha, Surgeon-in-chief at NewYork-Presbyterian/Columbia University Irving Medical Center and professor of surgery at Columbia University Vagelos College of Physicians and Surgeons
“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.”
Bernard Zovighian, CEO of Edwards Lifesciences
“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.”
Edwards Lifesciences Receives FDA Approval for AUTUS Valve, the First Surgical Pulmonary Valve for Pediatric Patients
Edwards Lifesciences (NYSE: EW) today 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.
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