Edwards Lifesciences has received US Food and Drug Administration (FDA) approval for the 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 expand as a child grows. Its size can be increased through a minimally invasive transcatheter procedure, potentially reducing the need for repeated open-heart surgeries.
FDA approval was supported by clinical data from a pivotal study that met its primary safety and effectiveness endpoints.
All patients were free from device-related complications at 30 days, while no AUTUS valve reinterventions were reported through six months.
Among patients who completed one year of follow-up, all demonstrated consistent valve performance, including a right ventricular outflow tract mean gradient of 40 mmHg or less, less than moderate pulmonary regurgitation and no valve reinterventions.
Patients will continue to be monitored for up to 10 years.
The AUTUS valve previously received FDA Breakthrough Device Designation for its potential to address an unmet need in paediatric congenital heart care.
The approval expands Edwards’ portfolio of congenital heart solutions and provides a growth-adaptable option for children requiring pulmonary valve replacement.
Source: https://www.edwards.com
