FDA Approves First Heart Valve That Grows With Children
The Autus Size-Adjustable Valve can be expanded after surgery, potentially reducing repeat operations for pediatric patients.
The FDA has approved the Autus Size-Adjustable Valve, the first heart valve that can be expanded after surgery to grow with children. The artificial pulmonary valve is designed for pediatric patients and can be implanted as small as 13 millimeters in diameter, then expanded up to 22 millimeters using a balloon catheter.
It is the first adjustable heart valve and the first to use polymeric material for its flaps. FDA follow-up data after one year suggests the valve holds up better than other models over time.
Artificial pulmonary valves have long been implantable, but they typically require a series of surgeries to replace them with bigger ones as the child grows. Implants usually use synthetic flaps made from animal materials that tend to harden and break down faster in children.
Around 400,000 children a year born in the US suffer from some form of congenital heart disease, according to a study published in the National Library of Medicine. Approximately 30 percent of those cases affect the valves. Pulmonary valve stenosis and atresia together affect around 4,200 babies born in the United States every year, according to the CDC.
The approval was reported by Engadget.
Quick answers
What is the Autus Size-Adjustable Valve?
It is an artificial pulmonary heart valve for children that can be expanded after surgery, from 13 millimeters up to 22 millimeters using a balloon catheter.
Why is this heart valve different?
It is the first adjustable heart valve and the first to use polymeric material for its flaps, which may help it last longer than existing models.
How many children are affected by congenital heart disease?
Around 400,000 children a year born in the US have some form of congenital heart disease, and about 30 percent of cases affect the valves.