Integra LifeSciences Announces First Patient Enrolled in Acclarent AERA® Pediatric Registry

Integra LifeSciences is proud to announce enrollment of the first patient in the Acclarent AERA Pediatric Registry, a prospective, multi-center observational registry evaluating the real-world use of the AERA Eustachian Tube Balloon Dilation System in children.

This inaugural enrollment marks the focused effort to measure the ongoing, real-world clinical performance of AERA in pediatric patients with obstructive Eustachian tube dysfunction (ETD). Dr. Prasad Thottam at Michigan Pediatric ENT Associates enrolled the first patient; “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 registry is designed to capture both safety and efficacy outcomes for up to 300 pediatric patients who undergo Eustachian tube balloon dilation (ETBD) using AERA. "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,” said 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 primary endpoint of the registry is a failure-free status following ETBD with the AERA device; failure being defined as the need for revision surgery, including additional ETBD procedures, tympanostomy tube placement or adenoidectomy due to ETD. Secondary endpoints include tympanogram results, pure tone audiometry, the Valsalva maneuver, inflammation scores, and patient-reported outcomes. The registry will also capture the rate of successful balloon dilation during procedures, and all adverse events or complications will be monitored as part of the safety assessment. Up to 20 sites across the U.S. are expected to participate in this registry. The data generated will provide valuable real-world insights into pediatric ETBD procedures and support broader efforts to improve reimbursement pathways and clinical adoption.

Click here for the full press release.