Integra LifeSciences Holding Corporation has announced the enrollment of the first patient in the Acclarent AERA Pediatric Registry, marking a significant milestone in pediatric ENT care. The prospective, multi-center observational registry will evaluate the real-world clinical performance of the AERA Eustachian Tube Balloon Dilation System in children with obstructive Eustachian tube dysfunction (ETD).
Dr. Prasad Thottam at Michigan Pediatric ENT Associates enrolled the inaugural patient in the registry. "We are proud to support this important initiative and even prouder that our team was the first to register a patient in the registry," remarked Thottam. The physician emphasized the registry's importance in advancing pediatric ENT care, stating, "In our ongoing commitment to better understand and treat pediatric Eustachian tube dysfunction and middle ear disease, the Acclarent AERA Pediatric Registry marks a critical advancement."
Registry Design and Objectives
The registry is designed to capture comprehensive safety and efficacy outcomes for up to 300 pediatric patients who undergo Eustachian tube balloon dilation (ETBD) using the AERA device. Up to 20 sites across the United States are expected to participate in this observational study.
The primary endpoint of the registry is failure-free status following ETBD with the AERA device. Failure is specifically defined as the need for revision surgery, including additional ETBD procedures, tympanostomy tube placement, or adenoidectomy due to ETD.
Secondary endpoints encompass a broad range of clinical assessments, including tympanogram results, pure tone audiometry, the Valsalva maneuver, inflammation scores, and patient-reported outcomes. The registry will also monitor the rate of successful balloon dilation during procedures, with all adverse events or complications tracked as part of the comprehensive safety assessment.
Clinical Impact and Future Implications
The data generated from this registry will provide valuable real-world insights into pediatric ETBD procedures and support broader efforts to improve reimbursement pathways and clinical adoption. According to Thottam, "This milestone reflects not only the field's dedication to improving pediatric ENT care, but also Integra's commitment to advancing safe, evidence-based innovation in this space."
The registry represents a focused effort to measure the ongoing, real-world clinical performance of AERA specifically in pediatric patients with obstructive Eustachian tube dysfunction, addressing a critical gap in pediatric ENT treatment options and evidence generation.
