Integra LifeSciences announces the first patient enrollment in a registry assessing the AERA system for pediatric ETD treatment.
Quiver AI Summary
Integra LifeSciences Holding Corporation has announced the enrollment of the first patient in the Acclarent AERA Pediatric Registry, which aims to evaluate the real-world use of the AERA Eustachian Tube Balloon Dilation System in children with obstructive Eustachian tube dysfunction. The registry, initiated by Dr. Prasad Thottam, will track safety and efficacy outcomes for up to 300 pediatric patients undergoing this treatment. Key metrics will include the rate of failure-free status post-procedure and various clinical parameters. Up to 20 U.S. sites are expected to participate, and the collected data will help enhance understanding of pediatric Eustachian tube procedures and inform clinical practice and reimbursement strategies. Integra remains committed to advancing safe, evidence-based innovations in pediatric ENT care.
Potential Positives
- Integra LifeSciences has successfully enrolled the first patient in the Acclarent AERA Pediatric Registry, indicating a significant step forward in assessing the AERA Eustachian Tube Balloon Dilation System for pediatric patients.
- The registry aims to provide valuable real-world clinical data, which could enhance the understanding and treatment of pediatric Eustachian tube dysfunction, thus reinforcing the company's commitment to patient care.
- With up to 20 sites expected to participate, the registry will generate comprehensive data that may support improved reimbursement pathways and clinical adoption of the AERA system.
Potential Negatives
- The press release includes a lengthy disclaimer regarding forward-looking statements, which may highlight uncertainty and risks associated with the AERA Pediatric Registry and its anticipated outcomes.
- There is no guarantee mentioned that the registry will meet its enrollment and observation objectives, indicating potential challenges in the project's execution.
- The mention of potential complications and the monitoring of adverse events could raise concerns about the safety of the AERA Eustachian Tube Balloon Dilation System in pediatric patients.
FAQ
What is the Acclarent AERA Pediatric Registry?
The Acclarent AERA Pediatric Registry is an observational study evaluating the use of the AERA system in children with Eustachian tube dysfunction.
Who enrolled the first patient in the registry?
Dr. Prasad Thottam at Michigan Pediatric ENT Associates enrolled the first patient in the Acclarent AERA Pediatric Registry.
What are the primary goals of the AERA Pediatric Registry?
The primary goal is to assess failure-free status after Eustachian tube balloon dilation procedures using the AERA device.
How many patients will the registry include?
The registry aims to include up to 300 pediatric patients undergoing Eustachian tube balloon dilation procedures.
What outcomes will the registry measure?
The registry will monitor safety, efficacy, tympanogram results, and patient-reported outcomes related to Eustachian tube dysfunction treatment.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
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
[email protected]
Media:
Laurene Isip
(609) 208-8121
[email protected]
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/9eba7036-e0df-46e3-86d5-58984365f3f5