acclarent
acclarent

Where Tech Meets Skill

With the right tools, your unique abilities can take ENT surgery further.

acclarent
acclarent

My Health Can't Wait: An HCP Resource

Our tech is revolutionary. Your skill is essential.

Acclarent is focused on delivering products that amplify the unique skills of ENT surgeons

At Acclarent, we have a proud legacy of shaping the ENT landscape.

Not only are we committed to innovating in the ENT space, we also invest in supporting healthcare professionals with a variety of training resources. Explore what we have to offer at the Johnson & Johnson Institute.

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Welcome to the future of ENT

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References

  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.
  5. https://www.entnet.org/content/about-us

Disclosures

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 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. 
 
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. 

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. Prior to use, it is important to read the Instructions for Use and to understand the contraindications, warnings, and precautions associated with these devices, as well as all products mentioned on this resource.

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.

The RELIEVA CIRCA® Ethmoid Punch is an instrument for the excision of bone and soft tissue in the ethmoid sinus in adults, and is intended for use by or under the direction of a physician with experience in sinus surgery. The RELIEVA CIRCA® Ethmoid Punch use has described risks including unintended tissue trauma, bleeding and infection.

The ACCLARENT® SE Inflation Device is an instrument intended to inflate, deflate and monitor pressure in balloon catheters used in sinus and Eustachian tube procedures. Refer to the appropriate balloon catheter Instructions For Use (IFU) for contraindications specific to the chosen clinical application. WARNINGS and PRECAUTIONS:

  • Intended for single patient use only. DO NOT REUSE.
  • After use, the Inflation Device may be a potential biohazard. Handle and dispose of in accordance with accepted hospital procedures.
  • Do not use a device where the integrity of the sterile packaging has been compromised or if the device appears damaged.
  • Do not exceed the recommended maximum inflation pressure of the balloon catheter being used.
  • Do not use air or a gas medium to inflate the balloon.
  • Not compatible with INSPIRA Air® Balloon Dilation System.

The RELIEVA SPINPLUS™ Balloon Sinuplasty System is intended to: provide a means to access the sinus space and illuminate within and transilluminate across nasal and sinus structures; dilate the sinus ostia and spaces associated with the paranasal sinus cavities for diagnostic and therapeutic procedures; and irrigate from within a target sinus for therapeutic procedures and to facilitate diagnostic procedures.

For children aged 17 and under, the RELIEVA SPINPLUS™ Balloon Sinuplasty System is intended to: provide a means to access the sinus space and illuminate within and transilluminate across nasal and sinus structures; dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures; and irrigate from within the maxillary sinus for therapeutic procedures and to facilitate diagnostic procedures.

The RELIEVA SPINPLUS® NAV Balloon Sinuplasty System 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 for diagnostic and therapeutic procedures; and irrigate from within a target sinus for therapeutic procedures and to facilitate diagnostic procedures.

For children aged 17 and under, the RELIEVA SPINPLUS® NAV Balloon Sinuplasty System is intended to provide a means to access the sinus space, within and across nasal and sinus structures; dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures; and irrigate from within the maxillary sinus for therapeutic procedures and to facilitate diagnostic procedures.

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.

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.

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.

Prior to use, it is important to read the Instructions for Use and to understand the contraindications, warnings, and precautions associated with these devices. 
 
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 intended for Healthcare Professionals. This site is published by Acclarent, Inc., which is solely responsible for its contents. It is intended for visitors of the United States.  

© Acclarent, Inc. 2020. All rights reserved. Last updated on 5/19/2021

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