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ACCLARENT AERA® Eustachian Tube Balloon Dilation System Patient Selection
Identifying appropriate patients. Ear discomfort can be caused by a variety of conditions.
Clinical proven study with patients with persistent Eustachian tube dysfunction (ETD)
Patient inclusion criteria used to determine if a patient was a potential candidate with persistent ETD for admission into "A Randomized Clinical Study of Safety and Efficacy for the Eustachian Tube Balloon Catheter (ELLIOTT)”1.
Clinical evidence study methodology
The study was a prospective, multicenter, randomized, controlled trial to demonstrate superiority of the Eustachian tube balloon dilation with Eustachian tube balloon catheter in conjunction with medical management compared to medical management alone.
- Subjects age 22 and older diagnosed with persistent ETD.
- Persistent ETD is defined by patient-reported symptoms of ETD for 12 weeks or greater.
- Failure of medical management consisting of either a minimum of 4 weeks of continuous daily usage of any intranasal steroid spray or a minimum of one completed course of an oral steroid.
- Patients were required to have a computed tomography (CT) scan to confirm absence of internal carotid artery (ICA) dehiscence in the ET lumen.
- An abnormal tympanometry (type B or C) after failed medical management.
- Demonstrated symptomatic dysfunction as documented through a validated quality of life instrument (ETDQ-7) with a score ≥ 2.1 after failed medical management.
It is ultimately up to the healthcare provider's discretion to diagnose appropriate patients.
1ACCLARENT AERA® Eustachian Tube Balloon Dilation System Instructions for Use. Irvine, CA: Acclarent, Inc.; 2018. IFU005146 Rev E.
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 adults ages 18 and older.
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.
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Important information: Prior to use, refer to the instructions for use supplied with this device for indications, contraindications, side effects, warnings and precautions.
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© Acclarent, Inc. 2019. Last Updated on 10/11/2019