Edwards Lifesciences has received US Food and Drug Administration (FDA) approval for its AUTUS Size-Adjustable Valve, a surgical pulmonary valve designed for paediatric patients with congenital heart disease who require pulmonary valve replacement.

The AUTUS valve is designed to accommodate a child’s growth and can be expanded through a minimally invasive transcatheter procedure. This could reduce the need for repeated open-heart surgeries as paediatric patients grow.

FDA approval was supported by clinical evidence from the pivotal study, which met its primary safety and effectiveness endpoints. All patients remained free from device-related complications through 30 days, while no AUTUS valve reinterventions were reported through six months. Among patients completing one-year follow-up, all demonstrated consistent valve performance, including 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 had previously received FDA Breakthrough Device designation for its potential to address an unmet need in paediatric congenital heart care.

With the approval, Edwards expands its congenital heart treatment portfolio, which includes SAPIEN 3, the Alterra Adaptive Present and paediatric atrioseptostomy catheters. The company said the approval reflects its focus on developing structural heart technologies that address the long-term treatment needs of patients with congenital heart disease.