FDA Approves First Adjustable Pediatric Heart Valve That Grows With Children

The pulmonary valve sits on the right side of the heart and acts as a one-way door that keeps blood flowing in the right direction. The article, citing a study published in the National Library of Medicine, says about 400,000 children born in the United States each year have some form of congenital heart disease. Roughly 30 percent of those cases involve valves. Two common abnormalities of the pulmonary valve are stenosis, in which the valve is narrowed, and atresia, in which the valve fails to form normally. The Centers for Disease Control and Prevention says the two conditions together affect about 4,200 babies born in the United States each year.

Artificial pulmonary valves have been implanted for years, but they generally require a series of surgeries to replace them with larger valves as a child grows. The Autus can be implanted at as little as 13 millimeters in diameter in toddlers and preschool-aged children. If a patient is already older, it can be expanded to a larger size before surgery. Its distinguishing feature is that it can also be expanded inside the body.

Using a balloon catheter, a thin tube with an inflatable balloon at its tip, doctors can expand the Autus after surgery to match a child's growth. The valve can reach a maximum diameter of 22 millimeters, which the article says is comparable to the size of artificial valves made for adults. By removing the need for multiple operations, the device is intended to reduce risks for children with congenital heart disease.

The Autus is also the first heart valve to use polymeric material for its flaps. Existing implants typically use synthetic flaps made from animal materials, which tend to harden and break down faster in children and can require additional surgery. The FDA says one-year follow-up data on the Autus suggest it can hold up better over time than other models.

Editor's Summary The FDA has approved the Autus Size-Adjustable Valve, the first artificial pulmonary valve for children that can be expanded after implantation. The device, made by Edwards, is designed to grow with pediatric patients and reduce the need for repeated surgeries, which carry risks. It is also the first such valve with polymeric flaps, and one-year follow-up data cited by the FDA suggest it may last better than existing models.