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.
At Acclarent, we partner with physicians to deliver new technology that enables safe, fast and effective treatments in ENT.1
Where Tech Meets Skill
5% of the adult population may be affected by persistent Eustachian Tube Dysfunction (ETD) – 1 in 20.2 ACCLARENT AERA® Eustachian Tube Dilation System was designed to relieve symptoms of persistent ETD.
More than 30 million adults in the United States are diagnosed with sinusitis each year.3 Another common condition is nasal airway obstruction (NAO), which can be a source of significant patient discomfort and financial burden. Fortunately, Acclarent has products that address both of these conditions.
1. Karanfilov, B. Silvers, S. Pasha, R. (2012). Office-based balloon sinus dilation: a prospective, multicenter study of 203 patients. International Forum of Allergy & Rhinology.
2. Ockermann, T., Reineke, U., Upile, T., et al. (2010). Balloon Dilation Eustachian Tuboplasty: A Clinical Study. The Laryngoscope. 120; 1411-1416.
3. Rosenfeld, R.M., Piccirillo, J.F., Chandrasekhar, S.S., et al. (2015). Clinical Practice Guideline (Update): Adult Sinusitis. Otolaryngology – Head and Neck Surgery, 152(2S); S1–S39.
4. Nouraei, S.A.R., Ma, E., Patel, A., Howard, D.J., and Sandhu, G.S. (2007). Estimating the population incidence of adult post-intubation laryngotracheal stenosis. Clinical Otolaryngology, 32, 399–420.
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.
ACCLARENT® Balloon Sinuplasty Devices are intended for use by or under the direction of a physician who is trained in the use of Acclarent Technology. ACCLARENT® Balloon Sinuplasty Device use has described risks, including tissue and mucosal trauma, infection, or possible orbital injury.
Acclarent Navigation Technology is intended for use by or under the direction of a physician. Devices guided by the Acclarent Navigation Technology have described risks including the potential for unintended injury to the orbits or CNS as a consequence of inaccurate navigation.
The RELIEVA TRACT™ Nasal Balloon Dilation System is an instrument intended to provide increased intranasal space to facilitate access for endonasal and trans-nasal procedures and/or temporarily address nasal obstruction by displacing the inferior turbinate and lower nasal septum. The RELIEVA TRACT™ Nasal Balloon Dilation System is intended for use in ages 17 years or older. Balloon dilation catheters should be used by or under supervision of physicians thoroughly trained in balloon dilation. A thorough understanding of the technical principles, clinical application, and risk associated with balloon dilation of the nasal passage is necessary before using this device.
Important Safety Information
Prior to use, it is important to read the Instructions for Use and to understand the registration process and the contraindications, warnings and precautions described for the systems.
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.
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. 2019. Last Updated on 1/24/2020