The FDA has approved a new surgical pulmonary valve intended for children with congenital heart disease. The Autus Size-Adjustable Valve is the first prosthetic valve designed specifically for pediatric anatomy, and it can be expanded over time to match a child's growth. This feature may reduce the number of open-heart surgeries these patients need.
The valve is available in sizes as small as 13 mm for a toddler and can be incrementally widened using balloon catheterization to 22 mm, the size for an adult. It is also the first FDA-approved heart valve to use polymeric leaflets rather than animal-derived tissue, which the agency says may be more durable. Approval was based on a 62-patient pivotal study that showed acceptable hemodynamic performance with no more than mild pulmonary regurgitation. All participants were free of device-related complications at 30 days, and none required valve reintervention within six months.
Michelle Tarver, director of the FDA's Center for Devices and Radiological Health, said the valve could mean far fewer trips to the operating room. Emile Bacha of NewYork-Presbyterian/Columbia University Irving Medical Center, an author on the pivotal study, said it gives congenital heart teams a new way to think about long-term care planning. A continued access study is underway with follow-up planned through 10 years.