FDA clears expandable pulmonary valve designed for growing children
The FDA has approved the Autus Size-Adjustable Valve, the first artificial heart valve that can expand post-surgery to grow with children, eliminating the need for multiple replacement operations. Developed by Edwards, this pulmonary valve represents a significant breakthrough for paediatric patients with congenital heart disease who previously required repeated surgical interventions.
The valve can be implanted as small as 13 millimetres in diameter for toddlers and expanded to 22 millimetres post-surgery using a balloon catheter. Approximately 400,000 children born annually in the US have congenital heart disease, with around 30 per cent involving valve problems; about 4,200 babies per year develop pulmonary valve defects such as stenosis or atresia. The Autus uniquely uses polymeric flaps rather than animal-derived synthetic materials, which typically deteriorate faster in children, and one-year follow-up data shows superior durability compared to existing models.
- FDA approves first expandable heart valve for children with congenital disease.
- Valve expands post-surgery, eliminating need for repeated operations as child grows.
- New polymeric material design lasts longer than animal-derived alternatives in young patients.
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Congenital heart disease affects around 400,000 children born each year in the United States, with approximately one-third developing problems with the heart's valves. Around 4,200 babies annually are born with pulmonary valve defects, which occur when a valve between the heart and lungs fails to work properly, requiring surgical intervention.
Children with pulmonary valve defects have historically faced a significant problem: artificial valves implanted during surgery cannot grow with their bodies. This has meant that most children required multiple major surgical operations throughout childhood and adolescence to replace their valve as they grew, each procedure carrying surgical risks and requiring substantial recovery time.
The Autus valve, developed by Edwards, differs from existing heart valve designs by being able to expand within the body as the child grows. This eliminates the need for repeated replacement operations. The valve uses synthetic materials that have shown greater durability in children compared to animal-derived materials traditionally used in heart surgery.
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Originally published by Engadget as “FDA approves artificial heart valve for kids that grows as they do”.
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