Medical devices
FDA approves expandable pulmonary valve for children
The Autus valve can be widened from about 13 millimeters to 22 millimeters as a child grows, potentially reducing repeat open-heart surgeries.
The FDA approved Edwards Lifesciences’ Autus Size-Adjustable Valve, a surgically implanted pulmonary valve for children with congenital pulmonary valve disease. It is designed to be widened after implantation as a child grows, and is the first FDA-approved heart valve to use polymeric material for its leaflets rather than animal-derived tissue.
The valve can be implanted at approximately 13 millimeters in diameter and widened to 22 millimeters using a balloon catheter. In the study of 62 children at 12 U.S. sites, the FDA said the first 60 patients had acceptable blood flow and no more than mild leakage at six months. Three patients had a valve-frame fracture and two had reduced movement of a leaflet, but none of those events caused symptoms.
The FDA said two children whose valves began to deteriorate as they outgrew them had the valves expanded without an invasive surgical procedure. Longer-term studies are underway, and Edwards said study patients will be followed for 10 years.
Reporting on this story
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- FDA Newsroom FDA Approves First Heart Valve Designed to Grow with Children (opens in a new tab)
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