FDA Approves Artificial Heart Valve For Kids That Grows As They Do

The US Food and Drug Administration (FDA) has just approved the first heart valve that can be expanded post-surgery so it keep growing with children. Designed by a company called Edwards, the Autus Size-Adjustable Valve is an artificial pulmonary valve designed to be implanted into pediatric patients. 

According to a study published in the National Library of Medicine, around 400,000 children a year born in the US suffer from some form of congenital heart disease. Approximately 30 percent of those cases affect the valves, which are tissue flaps serving as one-way doors to keep blood flowing in the right direction out into the body. Two main abnormalities of the pulmonary valve, or the valve on the right side of the heart, are stenosis and atresia. Stenosis is when the valve is narrowed, while atresia is what you call the condition when the valve fails to form normally. Centers for Disease Control and Prevention says that together, they affect around 4,200 babies born in the United States every year.

While it has long been possible to implant artificial pulmonary valves, they typically require a series of surgeries to replace them with bigger and bigger ones as the child grows. The Autus Size-Adjustable Valve can be implanted as small as 13 millimeters in diameter in toddlers and preschool-aged children. It can be expanded to a bigger size pre-surgery if the patient is already older. But what makes this particular model a game changer for pediatric patients is that it can be expanded inside the body. 

Using a balloon catheter, which is a thin tube with a balloon at the tip that can be inflated, the Autus can be expanded post-surgery to keep pace with a child’s growth. It can reach a maximum of 22 millimeters in diameter that’s comparable to the size of artificial valves meant for adults. Eliminating the need for multiple surgeries lessens the risks for children with congenital heart diseases.

In addition to being the first adjustable heart valve, the Autus is also the first one that uses polymeric material for flaps. Typically, implants use synthetic flaps made from animal materials that tend to harden and break down faster in children, thereby requiring even more surgery. The FDA says Autus’ follow-up data after a year suggests it can hold up better than other models over time.