Heart valve that grows with children gets FDA approval

The Us Food and Drug Administration (FDA) has approved the AUTUS Size-Adjustable Valve, a surgical pulmonary valve designed specifically for paediatric patients with congenital heart disease who require pulmonary valve replacement.
For many paediatric patients, pulmonary valve replacement is not a one-time event. The AUTUS valve is the first FDA-approved surgical pulmonary valve designed for paediatric anatomy and can be expanded as a child grows.
Doctors perform valve expansion through a minimally invasive transcatheter procedure, which may reduce the need for repeat open-heart surgery.
Dr Emile Bacha is surgeon-in-chief at New York-Presbyterian/Columbia University Irving Medical Centre, a professor of surgery at Columbia University Vagelos College of Physicians and Surgeons, and an investigator in the trial.
He said: ‘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 paediatric patients who may otherwise face multiple surgeries.’
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 favourable valve performance with no AUTUS valve reinterventions through six months.
The AUTUS valve reflects Edwards’ decades-long focus, commitment and leadership in structural heart innovation designed to address patients’ needs throughout their lives.
It offers an important opportunity to support paediatric patients with congenital heart disease. This approval expands Edwards’ congenital treatment options, including SAPIEN 3, the Alterra Adaptive Prestent, and paediatric atrioseptostomy catheters.
Bernard Zovighian, Edwards’ CEO, said: ‘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.’