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ACCLARENT® Balloon Inflation Device
The ACCLARENT® Balloon Inflation Device is used to control the inflation and deflation of the various ACCLARENT® Balloon Catheters.
|BID30||Balloon Catheter Inflation|
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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.
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.
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.
Acclarent Devices are intended for use by or under the direction of a physician who is trained in the use of Acclarent Technology. INSPIRA AIR® Balloon Dilation System use has described risks, including serious complications such as airway obstruction, airway rupture (partial or complete) resulting in pneumomediastinum, pneumothorax and mediastinitis, chest pain, bronchospasm, atelectasis, pulmonary edema and bleeding.
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