FDA approves first heart valve that grows with children
The U.S. Food and Drug Administration (FDA) has approved the Edwards Lifesciences Autus surgical pulmonary valve that is the first size-adjustable valve designed for pediatric patients with congenital heart disease. The valve previously received FDA Breakthrough Device designation for its potential to address an important unmet need.
Typically children with congenital heart disease outgrow their valves and require repeat open heart surgeries to explant the old valves and implant larger valves. Instead of repeat surgeries, the Autus is designed to be expanded as a child grows through a minimally invasive transcatheter procedure, offering a new, less invasive way to care for these children over the long term.
"This valve is a game changer,” explained Jennifer Romano, MD, MS, a heart surgeon at C.S. Mott Children’s Hospital, and past-president of the Society of Thoracic Surgeons (STS), in a statement from September when her team performed the first Autus Valve implantation in the Continued Access study. “Typically, we give these children a temporary fix, knowing they will need more surgeries down the road. “Now, we may be giving a child a valve that could potentially last them a lifetime. This could be transformative.”
“Children with congenital pulmonary valve disease have long needed prosthetic valves that can account for growth over time,” explained Emile Bacha, MD, 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, in a statement. He was one of the investigators in the FDA pivotal trial for the device, and immediate past-president of the American Association for Thoracic Surgery (AATS). “The Autus valve gives congenital heart teams a new way to think about long-term care planning for pediatric patients who may otherwise face multiple surgeries.”
The FDA approved the Autus valve based on the positive results from its pivotal study. The valve met its primary safety and efficacy endpoints, with 100% of patients free from device-related complications through 30 days and no valve reinterventions through six months. It demonstrated a right ventricular outflow tract (RVOT) mean gradient of 40 mmHg or less, less than moderate pulmonary regurgitation. Patients will continue to be followed for 10 years.
FDA hails the Autus as a win for its breakthrough device program
The FDA also sent out a long statement about the innovation of this device and that it is one of the big success stories of the FDA Breakthrough Device designation program.
The FDA said the clinical study enrolled 62 pediatric patients across 12 U.S. sites. At the six-month follow-up, the first 60 patients demonstrated acceptable hemodynamic performance, and there was no more than mild regurgitation back through the valve. All patients in the study had a successful procedure, with no deaths, blood clots requiring additional treatment, strokes or other clot-related complications. Three patients experienced a fracture in the valve frame and two patients had reduced movement of one of the valve leaflets, but none of these events resulted in symptoms for the patients.
“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,” said Michelle Tarver, MD, PhD, director of the FDA’s Center for Devices and Radiological Health in the statement. “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.”
The Autus Size-Adjustable Valve can be initially implanted as small as approximately 13 mm in diameter for a toddler or preschool-aged child. The FDA said this can later be widened using a small inflatable balloon catheter as the child grows, eventually reaching up to 22 mm, which is comparable to an adult-sized pulmonary valve.
The Autus also uses polymeric material for the valve leaflets. Most valves use biological tissue derived from animals, but the FDA said these materials tend to harden and break down faster in children, which is another driver requiring earlier repeat surgeries. One-year follow-up data suggest the Autus valve’s synthetic leaflets hold up well over time.
Importantly, the FDA noted this is the first time the agency has approved a valve that uses polymeric leaflet material for any indication.
Edwards Lifesciences purchased Autus Valve Technologies in February 2026 for $128.9 million.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: [email protected]