Global Finance News
02 Oct 2026, 19:43
Edwards Lifesciences Wins FDA Approval for AUTUS Pediatric Pulmonary Valve
Edwards Lifesciences received FDA approval for its AUTUS Size-Adjustable Valve, the first surgical pulmonary valve specifically designed for pediatric patients with congenital heart disease who require pulmonary valve replacement.
A key feature of AUTUS is its ability to expand as a child grows. The valve can be enlarged through a minimally invasive transcatheter procedure, potentially reducing the need for multiple open-heart surgeries over a patient’s lifetime.
The FDA decision was supported by results from a pivotal study that met its primary safety and effectiveness endpoints. All patients were free from device-related complications through 30 days, and no AUTUS valve reinterventions were reported through six months. Among patients completing one-year follow-up, 100% met the study’s valve-performance criteria, 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. AUTUS had previously received FDA Breakthrough Device designation.
The approval expands Edwards Lifesciences’ congenital heart portfolio, which already includes SAPIEN 3, the Alterra Adaptive Prestent and pediatric atrioseptostomy catheters. For Edwards, AUTUS adds another structural-heart platform and extends its reach into pediatric congenital care, an area with relatively limited treatment options.
Edwards Lifesciences received FDA approval for its AUTUS Size-Adjustable Valve, the first surgical pulmonary valve specifically designed for pediatric patients with congenital heart disease who require pulmonary valve replacement.
A key feature of AUTUS is its ability to expand as a child grows. The valve can be enlarged through a minimally invasive transcatheter procedure, potentially reducing the need for multiple open-heart surgeries over a patient’s lifetime.
The FDA decision was supported by results from a pivotal study that met its primary safety and effectiveness endpoints. All patients were free from device-related complications through 30 days, and no AUTUS valve reinterventions were reported through six months. Among patients completing one-year follow-up, 100% met the study’s valve-performance criteria, 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. AUTUS had previously received FDA Breakthrough Device designation.
The approval expands Edwards Lifesciences’ congenital heart portfolio, which already includes SAPIEN 3, the Alterra Adaptive Prestent and pediatric atrioseptostomy catheters. For Edwards, AUTUS adds another structural-heart platform and extends its reach into pediatric congenital care, an area with relatively limited treatment options.
