Integra LifeSciences (IART) said late Wednesday it enrolled its first patient in the Acclarent AERA Pediatric Registry, which assesses the outcomes of the AERA Eustachian Tube Balloon Dilation System in children with obstructive Eustachian tube dysfunction.
The registry will capture safety, efficacy, and procedural outcomes for up to 300 pediatric patients who undergo Eustachian tube balloon dilation using AERA, according to a statement.
The primary endpoint of the registry is to achieve a failure-free status following the procedure, while secondary endpoints include inflammation scores and patient-reported outcomes, the company said.
Up to 20 sites in the US are expected to participate in the registry, it added.
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