Integra LifeSciences Announces 100th Patient Enrolled in AERA® Pediatric Registry
Key Highlights
- ➤AERA Pediatric Registry reaches 100 patients, one-third of planned 300-patient enrollment
- ➤Registry evaluates real-world pediatric performance of AERA in patients ages eight and older
- ➤AERA received FDA pediatric clearance in December 2023, first and only indicated system
- ➤Integra (IART) continues investing in clinical evidence for pediatric Eustachian tube dysfunction
Expert Statements
Christopher Schutt, Vice president, Operations & Excellence, Office of the Chief Medical Officer, Integra LifeSciences
“Reaching the 100-patient milestone reflects meaningful progress in building real-world evidence in pediatric Eustachian tube dysfunction and its treatment”
Christopher Schutt, Vice president, Operations & Excellence, Office of the Chief Medical Officer, Integra LifeSciences
“We are grateful to the research teams and families whose participation is making this work possible. We are hopeful their contributions will help inform future clinical decision-making and advance understanding of care for children with ETD.”
Harvinder Singh, Executive vice president and president, Specialty Surgery, Integra LifeSciences
“This milestone reinforces our commitment to the ear, nose, and throat (“ENT”) market and to advancing the evidence base supporting innovative treatment options for patients with Eustachian tube dysfunction”
Harvinder Singh, Executive vice president and president, Specialty Surgery, Integra LifeSciences
“We believe continued investment in clinical evidence generation is essential to supporting physicians, informing care decisions and strengthening our leadership position in ENT.”
PRINCETON, N.J., Sept. 29, 2026 (GLOBE NEWSWIRE) -- Integra LifeSciences (Nasdaq: IART), a leading global medical technology company, announced today the enrollment of the 100th patient in the AERA® Pediatric Registry, a prospective, multicenter observational registry evaluating the real-world clinical performance of the Acclarent AERA Eustachian Tube Balloon Dilation System in pediatric patients eight or older.
The milestone represents one-third of the registry’s planned enrollment of 300 patients and reflects the continued collaboration of participating investigators, research coordinators and clinical sites across the United States. Launched in July 2025, the registry is designed to generate real-world evidence regarding the use of AERA in children with obstructive Eustachian tube dysfunction, or ETD.
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