Workflow
Acclarent AERA® Eustachian Tube Balloon Dilation System
icon
Search documents
Integra LifeSciences Announces First Patient Enrolled in Acclarent AERA® Pediatric Registry
Globenewswire· 2025-07-02 20:09
Core Insights - Integra LifeSciences has enrolled the first patient in the Acclarent AERA Pediatric Registry, aimed at evaluating the real-world use of the AERA Eustachian Tube Balloon Dilation System in children [1][2] Company Overview - Integra LifeSciences is a global medical technology company focused on restoring patients' lives through innovative treatment pathways and high-quality medical technology brands [4] Registry Details - The Acclarent AERA Pediatric Registry is a prospective, multi-center observational study designed to assess safety and efficacy outcomes for up to 300 pediatric patients with obstructive Eustachian tube dysfunction (ETD) undergoing Eustachian tube balloon dilation (ETBD) [2][3] - The primary endpoint is defined as failure-free status post-ETBD, with failure including the need for revision surgery or additional procedures due to ETD [3] - Secondary endpoints will include tympanogram results, pure tone audiometry, inflammation scores, and patient-reported outcomes, along with monitoring adverse events [3] Clinical Impact - The registry aims to provide valuable insights into pediatric ETBD procedures, supporting efforts to improve reimbursement pathways and clinical adoption [3]