You are about to leave jnjmedicaldevices.com. By clicking to continue, you will be taken to a web site governed by their own Legal and Privacy Policies.
ACCLARENT AERA® Eustachian Tube Balloon Dilation System
The Acclarent AERA® Eustachian Tube Balloon Dilation System is the only available device in the U.S. specifically designed to dilate the Eustachian tube for patients with persistent ETD.
Features & Benefits
The Acclarent commitment
Acclarent is committed to offering training and support to help you successfully treat ETD. Treatment with the ACCLARENT AERA® device may allow more patients to regain normal ear function than with medical management alone.1
From individual support to practice management, our commitment includes:
- Training the specialist on the system
- Supporting the specialist in making this new treatment option available
- Providing the physician practice with education
Designed for safety
The first product of its kind, ACCLARENT AERA® was specifically designed for the Eustachian tube anatomy with flexibility to reach the source of the problem in a minimally invasive way.
Mechanism of action
Pathology lies within the cartilaginous segment of the Eustachian tube. Histopathology research has demonstrated that balloon dilation may:
- Shear or crush portions of the epithelium; usually sparing the basal layer and allowing for rapid healing
- Crush lymphocytes and lymphoid follicle
- Combined, these effects reduce overall inflammatory burden and may be the underlying reason for lasting clinical improvement in Eustachian tube dilation and ventilation.2
Proven effective and safe for ETD patients
ACCLARENT AERA® was studied in the only prospective, multicenter, randomized clinical trial of balloon dilation procedures.3
ETD and your patients
Studies indicate that adult prevalence of ETD is estimated to be between 0.9% and 5.0%.1,2
1. ACCLARENT AERA® Eustachian Tube Balloon Dilation System Instructions for Use. Irvine, CA: Acclarent, Inc.; 2018. IFU005146 Rev E.
2. Kivekäs I, Chao WC, Faquin W, et al. Histopathology of balloon-dilation Eustachian tuboplasty. Laryngoscope. 2015;125(2):436-441.
3. Sikand A, Silvers S, Pasha R, et al. Office-Based Balloon Sinus Dilation: 1-Year Follow-up of a Prospective, Multicenter Study. Annals of Otology, Rhinology & Laryngology. 2015;124(8): 630–637.
Important Safety Information:
ACCLARENT AERA® Eustachian Tube Balloon Dilation System is intended for use by physicians who are trained on Acclarent Technology. Eustachian tube balloon dilation has associated risks, including tissue and mucosal trauma, infection, or possible carotid artery injury. Prior to use, it is important to read the Instructions for Use and to understand the contraindications, warnings, and precautions associated with these devices.
Caution: Federal (US) law restricts the sale, distribution or use of these devices to, by or on the order of a physician. Third party trademarks used herein are trademarks of their respective owners. This content is intended for audience within the US only.
Important information: Prior to use, refer to the instructions for use supplied with this device for indications, contraindications, side effects, warnings and precautions.
This site is published by Acclarent, Inc. which is solely responsible for its contents. It is intended for visitors from the United States.
© Acclarent, Inc. 2021. Last Updated on 10/5/2021