Designed for safety

The first approach 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.1

The bulb tip enhances safety by limiting balloon catheter travel into the isthmus
1

Designed specifically for the Eustachian tube anatomy

2

Offers flexibility to adapt to the
S-shaped curve of the Eustachian tube

3

Preserves natural anatomy with minimally invasive, transnasal access

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. The clinical trial results were1:

99.7 %
Technical success was high in accessing
and dilating Eustachian tubes.
51.8% vs 13.9%
Higher rate of tympanogram normalization
in investigational subjects vs control subjects treated
with medical management alone.
56.1% vs 8.5%
Improvement in the quality of life as measured
by Eustachian Tube Dysfunction Questionnaire
(ETDQ-7) with more investigational subjects reporting
a mean item score < 2.1 vs control subjects.
0%
Serious device- or procedure-related
adverse events.

Become
ACCLARENT AERA®
trained

Contact your local
representative or call
877-775-2789 if you are
a physician interested in
learning more about
ACCLARENT AERA® Eustachian
Tube Balloon Dilation System training.

Call
877-775-2789
to learn more
about training.

References

  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.

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® 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.

View ACCLARENT AERA® Instructions for Use