A team from Ann Arbor-based University of Michigan Health C.S. Mott Children’s Hospital was first in the U.S. to implant a pediatric heart valve as part of a continued access study.
A six-year-old child received the device — Edwards Lifesciences’ Autus Valve — in August, according to an Aug. 31 news release from Michigan Medicine.
Under the continued access study, patients who need a replacement pulmonary valve can receive the device while the FDA reviews the trial results.
Researchers will follow patients who participate in the study for years, as the valve is designed to expand as children grow, the release said.
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