Medical devices
FDA approves adjustable pulmonary valve designed to expand as children grow
The valve can be expanded to keep pace with a child’s growth, potentially reducing the need for repeat surgeries.
The FDA approved the Autus Size-Adjustable Valve, a replacement pulmonary valve designed for children with congenital pulmonary valve disease. It is the first approved valve designed to be expanded after implantation.
The valve can be implanted at approximately 13 mm in diameter and expanded up to 22 mm using balloon dilation, according to the reports. The FDA said approval was based on a study of 62 children at 12 U.S. sites, aged 18 months to 16 years. Its inner leaflets are made from polymeric material rather than animal-derived tissue, the FDA said.
At six months, the FDA said the first 60 patients had acceptable blood flow and no more than mild leakage through the valve. The agency also reported three valve-frame fractures and reduced movement of a leaflet in two patients, with none of those events causing symptoms. Edwards said study patients will be followed for 10 years.
