On October 1, 2026, the “FDA approved the Autus Size-Adjustable Valve, a surgically implanted pulmonary heart valve for pediatric patients with congenital pulmonary valve disease”. What makes this implantable heart valve device so special is that it can be adjusted in size as the child grows and, as a result, potentially eliminates the need for future multiple open heart surgeries to replace the valves. The FDA says “[T]he Autus Size-Adjustable Valve is the first heart valve designed to be expanded after surgery to keep pace with a child’s growth, and the first valve approved in the U.S. to use polymeric material rather than animal-derived tissue for its inner flaps (called leaflets)”.
“The Autus Size-Adjustable Valve can be initially implanted as small as approximately 13 millimeters in diameter — the right size for a toddler or preschool-aged child — and later widened using a small inflatable tube (balloon catheter) as the child grows, eventually reaching up to 22 millimeters, which is comparable to an adult-sized pulmonary valve.”
The Agency’s announcement described the clinical evaluation of the new heart valves and discussed current experience and events associated with its use, as well as the successful expansion of the valve as the recipient grew.
The device was approved through the premarket approval (PMA) pathway and was evaluated by the FDA for safety and effectiveness that led to its approval. The Agency concluded that the device’s benefits outweighed its risks. More information can be found on the FDA’s webpage here. This device will offer a significant improvement on previously available therapeutic options for this congenital condition.
