Integra LifeSciences Holding Corporation announced the enrollment of the first patient in the Acclarent AERA Pediatric Registry. This prospective, multi-center observational registry is designed to evaluate the real-world use of the AERA Eustachian Tube Balloon Dilation System in children.
The registry aims to capture both safety and efficacy outcomes for up to 300 pediatric patients undergoing Eustachian tube balloon dilation (ETBD) with the AERA device. The primary endpoint is failure-free status, defined as the absence of revision surgery due to Eustachian tube dysfunction (ETD).
This initiative underscores Integra's commitment to advancing evidence-based innovation in pediatric ENT care and expanding the addressable market for its Acclarent AERA system, which received 510k clearance for expanded pediatric indications in 2023. The data collected will support broader efforts to improve reimbursement pathways and clinical adoption.
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