Edwards Lifesciences has announced that 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.
The valve is designed for paediatric anatomy, with the ability to be expanded as a child grows. Valve expansion is performed through a minimally invasive transcatheter procedure, potentially reducing the need for repeat open-heart surgeries, Edwards says in a press release.
“Children with congenital pulmonary valve disease have long needed prosthetic valves that can account for growth over time,” said Emile Bacha, surgeon-in-chief at NewYork-Presbyterian/Columbia University Irving Medical Center and a professor of surgery at Columbia University Vagelos College of Physicians and Surgeons (both New York, USA) who was one of the investigators in a clinical trial of the device. “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 favorable valve performance with no valve reinterventions through six months. Among patients who completed one-year follow-up, 100% showed consistent outcomes, demonstrating a right ventricular outflow tract (RVOT) mean gradient of 40mmHg or less, less than moderate pulmonary regurgitation and no valve reinterventions. Patients will continue to be followed for 10 years. The Autus valve previously received FDA breakthrough device designation for its potential to address an important unmet need.
“For far too long, children with congenital heart defects who need pulmonary valve replacement have had very limited surgical options, and those options have historically required multiple open-heart surgeries as children grow,” said Acting FDA Commissioner Kyle Diamantas. “Today’s landmark approval is a historic turning point and reflects the Trump Administration and the FDA’s commitment to help bring innovative, life-changing devices to the patients who need them most.”
