Integra LifeSciences Announces First Patient Enrolled in Acclarent AERA® Pediatric Registry
Integra LifeSciences (Nasdaq: IART) has announced the enrollment of its first patient in the Acclarent AERA Pediatric Registry, a significant milestone in pediatric Eustachian tube dysfunction (ETD) treatment research. The registry will evaluate the real-world use of the AERA Eustachian Tube Balloon Dilation System in children.
The multi-center observational study aims to enroll up to 300 pediatric patients across 20 U.S. sites. Dr. Prasad Thottam at Michigan Pediatric ENT Associates enrolled the first patient. The registry will track safety and efficacy outcomes, with the primary endpoint focusing on failure-free status following the procedure. Secondary endpoints include various clinical measurements and patient-reported outcomes.
Integra LifeSciences (Nasdaq: IART) ha annunciato l'arruolamento del suo primo paziente nel Registro Pediatrico Acclarent AERA, un importante traguardo nella ricerca sul trattamento della disfunzione della tuba di Eustachio (ETD) nei bambini. Il registro valuterà l'uso reale del Sistema di Dilatazione con Palloncino della Tuba di Eustachio AERA nei pazienti pediatrici.
Lo studio osservazionale multicentrico punta a reclutare fino a 300 pazienti pediatrici in 20 centri negli Stati Uniti. Il dottor Prasad Thottam di Michigan Pediatric ENT Associates ha arruolato il primo paziente. Il registro monitorerà la sicurezza e l'efficacia, con l'endpoint primario focalizzato sullo stato privo di fallimenti dopo la procedura. Gli endpoint secondari includono varie misurazioni cliniche e risultati riferiti dai pazienti.
Integra LifeSciences (Nasdaq: IART) ha anunciado la inscripción de su primer paciente en el Registro Pediátrico Acclarent AERA, un hito importante en la investigación del tratamiento de la disfunción de la trompa de Eustaquio (ETD) en pediatría. El registro evaluará el uso en la práctica real del Sistema de Dilatación con Balón para la Trompa de Eustaquio AERA en niños.
El estudio observacional multicéntrico tiene como objetivo inscribir hasta 300 pacientes pediátricos en 20 sitios en EE.UU.. El Dr. Prasad Thottam de Michigan Pediatric ENT Associates inscribió al primer paciente. El registro hará seguimiento a la seguridad y eficacia, con el punto final primario centrado en el estado libre de fallos tras el procedimiento. Los puntos finales secundarios incluyen diversas mediciones clínicas y resultados reportados por los pacientes.
Integra LifeSciences (나스닥: IART)가 Acclarent AERA 소아 등록부에 첫 환자를 등록했다고 발표했습니다. 이는 소아 이관 기능장애(ETD) 치료 연구에 있어 중요한 이정표입니다. 이 등록부는 소아에서 AERA 이관 풍선 확장 시스템의 실제 사용을 평가할 예정입니다.
다기관 관찰 연구로, 미국 내 20개 기관에서 최대 300명의 소아 환자를 등록하는 것을 목표로 합니다. 미시간 소아 이비인후과 협회의 프라사드 토탐 박사가 첫 환자를 등록했습니다. 등록부는 안전성과 효능 결과를 추적하며, 주요 평가 지표는 시술 후 실패 없는 상태 유지에 중점을 둡니다. 부차적 평가 지표로는 다양한 임상 측정값과 환자 보고 결과가 포함됩니다.
Integra LifeSciences (Nasdaq : IART) a annoncé l'inscription de son premier patient dans le Registre Pédiatrique Acclarent AERA, une étape importante dans la recherche sur le traitement de la dysfonction de la trompe d’Eustache (ETD) chez l’enfant. Ce registre évaluera l’utilisation réelle du système de dilatation par ballonnet de la trompe d’Eustache AERA chez les enfants.
Cette étude observationnelle multicentrique vise à inclure jusqu’à 300 patients pédiatriques dans 20 centres aux États-Unis. Le Dr Prasad Thottam de Michigan Pediatric ENT Associates a inscrit le premier patient. Le registre suivra les résultats de sécurité et d’efficacité, l’objectif principal étant le maintien d’un état sans échec après la procédure. Les objectifs secondaires incluent diverses mesures cliniques et des résultats rapportés par les patients.
Integra LifeSciences (Nasdaq: IART) hat die Einschreibung des ersten Patienten im Acclarent AERA Pädiatrischen Register bekannt gegeben, ein bedeutender Meilenstein in der Forschung zur Behandlung der Eustachischen Röhrendysfunktion (ETD) bei Kindern. Das Register wird die Anwendung des AERA Eustachischen Röhren-Ballon-Dilatationssystems bei Kindern in der Praxis bewerten.
Die multizentrische Beobachtungsstudie zielt darauf ab, bis zu 300 pädiatrische Patienten an 20 Standorten in den USA einzuschreiben. Dr. Prasad Thottam von Michigan Pediatric ENT Associates hat den ersten Patienten eingeschrieben. Das Register wird Sicherheits- und Wirksamkeitsergebnisse verfolgen, wobei der primäre Endpunkt auf einen ausfallfreien Zustand nach dem Eingriff abzielt. Sekundäre Endpunkte umfassen verschiedene klinische Messungen und patientenberichtete Ergebnisse.
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PRINCETON, N.J., July 02, 2025 (GLOBE NEWSWIRE) -- Integra LifeSciences Holding Corporation (Nasdaq: IART), a leading global medical technology company, 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.
About Integra LifeSciences
At Integra LifeSciences, we are driven by our purpose of restoring patients’ lives. We innovate treatment pathways to advance patient outcomes and set new standards of surgical, neurologic, and regenerative care. We offer a comprehensive portfolio of high quality, leadership medical technology brands. For the latest news and information about Integra and its products, please visit www.integralife.com.
Forward-Looking Statements
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve risks and uncertainties that could cause actual results to differ from predicted results. Forward-looking factors that may be discussed include, but are not limited to, the potential clinical application and efficacy of the AERA Eustachian Tube Balloon Dilation System in children, the number of patients and sites expected to be involved in the Acclarent AERA Pediatric Registry and the anticipated utility of data collected from the Acclarent AERA Pediatric Registry. There can be no assurance that the AERA Pediatric Registry will be able to meet the site, enrollment and observation objectives described herein or that any potential clinical applications and benefits will be observed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Integra’s business and market, particularly those identified under the heading "Risk Factors" included in item 1A of Integra's Annual Report on Form 10-K for the year ended December 31, 2024, and information contained in subsequent filings with the Securities and Exchange Commission. These forward-looking statements are made only as the date thereof, and Integra undertakes no obligation to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
Investor Relations:
Chris Ward
(609) 772-7736
chris.ward@integralife.com
Media:
Laurene Isip
(609) 208-8121
laurene.isip@integralife.com
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/9eba7036-e0df-46e3-86d5-58984365f3f5
FAQ
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