FDA approves artificial heart valve for kids that grows as they do
The Autus Size-Adjustable Valve eliminates the need for multiple surgeries.
Medical Breakthrough
The US Food and Drug Administration has approved the first heart valve that can be expanded post-surgery to grow with children. Designed by Edwards, the Autus Size-Adjustable Valve is an artificial pulmonary valve created for pediatric patients.
Studies indicate that hundreds of thousands of children are born annually with congenital heart conditions affecting tissue valves. Common pulmonary valve abnormalities include stenosis, where the valve is narrowed, and atresia, where the valve fails to form normally.
Expansion Technology
While traditional artificial pulmonary valves require multiple replacement surgeries as a child grows, the Autus valve can be implanted starting at 13 millimeters in diameter. Its key innovation is the ability to expand inside the body.
Medical professionals use a balloon catheter to expand the valve post-surgery, allowing it to reach up to 22 millimeters in diameter, comparable to adult-sized valves. This capability significantly reduces the risks associated with repeated pediatric surgeries.
Material Innovation
The Autus valve also features polymeric material for its flaps instead of traditional animal-derived materials, which tend to break down faster in young patients. One-year follow-up data evaluated by the FDA indicates improved durability over conventional models.
