Dear valued customer:
We are pleased to announce that on December 13, 2023, the ACCLARENT AERA® Eustachian Tube Balloon Dilation System received clearance from the U.S. Food and Drug Administration (FDA) to expand the indicated patient population from 18 years of age and older to 8 years of age and older.
ACCLARENT AERA® is the only Eustachian Tube Balloon Dilation System in the United States indicated for patients 8 years and older with persistent obstructive Eustachian tube dysfunction. This expanded indication of ACCLARENT AERA® Eustachian Tube Balloon Dilation System is a significant step forward in Acclarent’s goal to provide treatment options not only to adults but also to the millions of children that suffer from persistent Eustachian tube dysfunction.
To accelerate physicians’ access to this technology, we are providing updated Instructions for Use in a digital format. For complete instructions for use and important safety information on the ACCLARENT AERA® Eustachian Tube Balloon Dilation System, please visit the ACCLARENT AERA® Eustachian Tube Balloon Dilation System page on our website.
Summary of updated information:
|ACCLARENT AERA® Eustachian Tube Balloon Dilation System
UPDATED INDICATIONS FOR USE
The ACCLARENT AERA® Eustachian Tube Balloon Dilation System is intended to dilate the Eustachian tube for treatment of persistent Eustachian tube dysfunction in patients ages 18 and older.
For patients ages 8-17 years, the ACCLARENT AERA® Eustachian Tube Balloon Dilation System, alone or in combination with adjunctive procedures, is intended to treat patients with objective signs of persistent obstructive Eustachian tube dysfunction from inflammatory pathology, resulting in chronic otitis media with effusion and are refractory to at least one surgical intervention for persistent obstructive Eustachian tube dysfunction.
- DO NOT move the balloon while it is inflated. Ensure balloon is fully deflated during insertion and withdrawal.
- It is recommended to perform nasal endoscopy to evaluate if the patient anatomy and physiology is suitable for balloon dilation of the Eustachian Tube.
- Radiographic assessment of the targeted Eustachian tube is recommended prior to any procedure involving balloon tuboplasty. There is a small but known risk of malignancy in the pediatric population after CT scan radiation.
- Certain nasal anatomy such as a deviated nasal septum or small nasal volume may preclude access to the Eustachian tube/s resulting in failure to treat the target anatomy.
- DO NOT inflate the Balloon Catheter until it has exited the Guide Catheter.
- DO NOT bend the Guide Catheter shaft.
Please contact Customer Service at 1-877-775-2789 should you have any questions. Thank you for your continued partnership.
Head of Marketing
31 Technology Drive, Suite 200
Irvine, CA 92618 USA
Acclarent, Inc. 2023