Edwards Lifesciences’ Autus expandable pulmonary heart valve has become the first device of its kind to receive US Food and Drug Administration (FDA) approval for paediatric patients with congenital pulmonary valve disease.
Approved via the FDA’s premarket approval (PMA) pathway, the Edwards Autus size-adjustable valve is designed for initial implantation at around 13mm in diameter—the appropriate size for paediatric patients aged between one and five years old. It can be later widened using a balloon catheter to an eventual size of up to 22mm in diameter, comparable to an adult-sized pulmonary valve.
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It is intended to reduce the need for repeat open-heart surgeries in children with heart defects.
Congenital heart defects represent some of the most common types of birth defects in the US, affecting around one in every 100 babies. According to the US Centers for Disease Control and Prevention (CDC), the conditions impact around 4,200 children in the US each year.
Treatment for these conditions can improve blood flow and help repair these congenital defects, yet some children may be left with significant pulmonary regurgitation, or leakage of blood back through the pulmonary valve. Over time, this can weaken or enlarge the right ventricle and create a need for pulmonary valve replacement as the child grows.
FDA’s Center for Devices and Radiological Health (CDRH) director Michelle Tarver commented: “For children born with congenital heart disease, valve replacement timing has always been a difficult decision—wait too long and you risk harm to the child, but intervene too early and they may need multiple open-heart surgeries as they grow.”
“The Autus size-adjustable valve gives doctors the option of far fewer trips to the operating room, which may result in better quality of life for these children and their families.”
Autus’ approval was based on data from Edwards pivotal trial of the device (NCT05006404). The 62-patient study met its primary safety and effectiveness endpoints, with 100% of patients free from device-related complications through 30 days, demonstrating favourable valve performance with no valve reinterventions required through six months.
Among patients who completed a one-year follow-up, 100% showed consistent outcomes, demonstrating an RVOT mean gradient of 40mmHg or less, less than moderate pulmonary regurgitation and no valve reinterventions. Patients will continue to be followed for ten years.
Edwards Lifesciences CEO Bernard Zovighian said: “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.”
