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Important Safety Information:
ACCLARENT® TruDi® Curette is intended for use with the TruDi® Navigation System by or under the direction of a physician who is trained in the use of Acclarent Technology. TruDi® Curette is intended for use with the TruDi® Navigation System to manipulate, dissect and/or remove tissue, cartilage and bone during surgical procedures in ENT and ENT skull base surgery. A thorough understanding of the technical principles, clinical application, and risk associated with the use of ENT and ENT Skull Base procedures is necessary before using this device.
ACCLARENT® TruDi® Probe is intended for use with the TruDi® Navigation System by or under the direction of a physician who is trained in the use of Acclarent Technology. The TruDi® Probe is intended for use with the TruDi® Navigation System to locate anatomical structures during surgical procedures in ENT and ENT skull base surgery. A thorough understanding of the technical principles, clinical application, and risk associated with the use of ENT and ENT Skull Base procedures is necessary before using this device.
The ACCLARENT PIVOT™ is intended to dilate the cartilaginous Eustachian tube for treatment of persistent Eustachian tube dysfunction in patients ages 18 and older. It is intended to provide a means to access the sinus space within and across nasal and sinus structures; dilate the sinus ostia and spaces associated with the paranasal sinus cavities, or maxillary sinus in children aged 17 and under, for diagnostic and therapeutic procedures; irrigate from within a target sinus, or within the maxillary sinus for children aged 17 and under; suction throughout therapeutic procedures, and to facilitate diagnostic procedures.
The ACCLARENT PIVOT™ with the navigation guidewire may be utilized in conjunction with the TruDi® Navigation System, to help direct access to nasal and paranasal spaces, and to confirm placement in the targeted anatomy. The ACCLARENT PIVOT™ may be utilized in conjunction with the TruDi® NAVWIRE® Sinus Navigation Guidewire to confirm placement of the balloon in the Eustachian tube. The ACCLARENT PIVOT™ with the illumination guidewire may be utilized to illuminate within and provide transcutaneous illumination across nasal and sinus structures. A thorough understanding of the technical principles, clinical application, and risks associated with the use of ENT and ENT Skull Base procedures is necessary before using this device.
TruDi® NAV Suction Instruments are intended for use with the TruDi® Navigation System during surgical procedures in ENT medicine and skull base surgery to provide navigation of the instruments to the targeted anatomy, and evacuation of gases, liquids, and fragments.
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. 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 system.
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.
Acclarent, Inc.
Irvine, CA 92618

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. 2022. Last Updated on 1/20/2023

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