ACCLARENT PIVOT™ Navigation Balloon Dilation System

Change your tool, not your technique. The ACCLARENT PIVOT™ is an integrated balloon sinuplasty (BSP) and Eustachian tube balloon dilation (ETBD) device, available in light fiber and navigation guidewire configurations for compatibility with illumination and navigation technology.

ACCLARENT PIVOT™ Navigation Balloon Dilation System

Features & Benefits

Real Customization

Real Customization

  • Customize to any angle between 0º-110º within the anatomy, with the same instrument.
  • Customize tip orientation with 360° rotating ability.
  • Customizable or removable gripping features.
New Efficiency

New Efficiency

  • May offer a 50% reduction in procedural workflow steps vs. competition.†
  • Transition smoothly between frontal, sphenoid, and maxillary sinuses without removing the device

† Comparing typical procedural steps from each manufacturer’s Instructions for Use for the ACCLARENT PIVOT™ device vs. Medtronic NuVENT™ and Stryker XprESS™ devices for a 6-sinus balloon sinuplasty procedure with intrasinus irrigation.

True Innovation

True Innovation

  • One tool indicated for both sinus and eustachian tube dilation.
  • Less instrument exchange for reduced workflow and smooth transitions.

References

No available references for this product.

Important Safety Information: 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.

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.

169045-210303