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 procedure in the U.S. “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.
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]