OUR COMPANY AERIS TENAX INFINITY TUBAVENT RELIANCE
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TubaVent Balloon Inflation System
TUBAVENT® BALLOON DILATATION SYSTEM

Causal Therapy For
Eustachian Tube Dysfunction1

The gentle & patient-friendly2 option to treat Eustachian Tube Dysfunction. Reliably treat Eustachian Tube Dysfunction3 with the TubaVent® Balloon Dilatation System by SPIGGLE & THEIS. Available in outer diameter of 3.28mm and 4.94mm at 10 atm.

SPECIFICATIONS

Gentle &
Patient-Friendly

4.6% of the adult population in the U.S. suffer from Eustachian tube dysfunction (ETD).4 Balloon Eustachian Tuboplasty (BET) is the first-line interventional causal treatment of ETD.

Our long-term results suggest that BET is a safe and effective treatment1 for chronic obstructive Eustachian tube dysfunction, with a success rate of more than 70%. Treatment with the TubaVent® Balloon Dilatation System may help patients regain normal ear function sustainably, with excellent success rates and high patient satisfaction levels.5

The TubaVent® Balloon Dilatation System by SPIGGLE & THEIS is available in outer diameter of 3.28 mm & 4.94 mm at 10 atm.

TUBAVENT® BALLOON DILATATION SYSTEM

Specifically designed to treat Eustachian tube dysfunction

  • Two balloon sizes: 3.28mm and 4.94mm at 10 atm
  • Semi-compliant balloon allows for fine & precise adjustment
  • Excellent tactile feedback during insertion of catheter into Eustachian tube
  • Enhanced protection of the mucosa thanks to olive-shaped tip
  • Proven and trusted system, the TubaVent® has been used in over 125,000 cases worldwide. First used in Europe in 2010.

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IFU

INSTRUCTIONS

ADDITIONAL RESOURCES

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Balloon Eustachian tuboplasty: a retrospective cohort study. Schröder, S., Lehmann, M., Ebmeyer, J., Upile, T. & Sudhoff, H. Department of Otolaryngology, Head and Neck Surgery, Bielefeld Academic Teaching Hospital, Münster University, Bielefeld, Germany; Accepted for publication March 29, 2015; Clin. Otolaryngol. 2015, 40, 629-638
Treatment of Eustachian Tube Dysfunction With Balloon Dilation: A Systematic Review. Jolien Marieke Lieselot Huisman, MD; Froukje Jantina Verdam, MD, PhD ; Inge Stegeman, PhD; Jacob Alexander de Ru, MD, PhD. The Laryngoscope © 2017 The American Laryngological, Rhinological and Otological Society, Inc.
A Randomized Controlled Trial of Balloon Dilation as a Treatment for Persistent Eustachian Tube Dysfunction With 1-Year Follow-Up. Ted A. Meyer, Ellen M. O'Malley, Rodney J. Schlosser, Zachary M. Soler, Jason Cai, Mark J. Hoy, Patrick W. Slater, Jeffrey L. Cutler, Roger J. Simpson, Michael J. Clark, Habib G. Rizk, Theodore R. McRackan, Christopher F. D'Esposito, and Shaun A. Nguyen. Department of Otolaryngology-Head and Neck Surgery, Medical University of South Carolina, Charleston, South Carolina; Entellus Medical, Inc., Plymouth, Minnesota; North American Science Associates (NAMSA), Shanghai, China; Austin Ear Clinic, Austin, Texas; Colorado Sinus Institute, Denver, Colorado; Ear Nose Throat and Sinus Clinic, LLC, North Platte, Nebraska; and Donald Guthrie Foundation, Sayre, Pennsylvania Otology & Neurotology 39:894-902, 2018
Patulous Eustachian tube Dysfunction Symptoms Following Balloon Dilation. The Laryngoscope © 2023. The American Laryngological,Rhinological and Otological Society, Inc., Richard D. Hubbell, MD; Joonas Toivonen, MD; Kosuke Kawai, ScD; H. Jeffrey Kim, MD; Carrie L. Nieman, MD, MPH, Bryan K. Ward, MD; Dennis S. Poe, MD, PhD
Balloon Eustachian tuboplasty for obstructive Eustachian tube dysfunction: retrospective multicentre cohort study of 248 patients. Marta Sandoval, Juan-J Navarro, Paz Martinez-Beneyto, Mayte Herrera, Jorge Alfaro, Felipe Lopez, Jaime Marco, and Guillermo Plaza. European Archives of Oto-Rhino-Laryngology © 2023
Prevalence of Eustachian Tube Dysfunction in Adults in the United States. Shan A, Ward BK, Goman A.M., et al. (2019) JAMA Otolaryngology Head Neck Surgery 145, no. 10: 974-975.
Balloon Eustachian Tuboplasty (BET) in Children: A Retrospective Multicenter Analysis. Otology & Neurotology. July 2020. Matthias Tisch, Susanne Maier, Serena Preyer, Savvas Kourtidis, Goetz Lehnerdt, Sebastian Winterhoff, Carsten V. Dalchow, Friederike Mueller-Jenckel, Holger H. Sudhoff, Stefanie Schröder, Assen Koitschev, Peter Amrhein, Karl Ludwig Bruchhage, Anke Leichtle, Christian Güldner, Juergen Grulich-Henn, Katrin Jensen, Moritz Pohl, Peter K. Plinkert, and Sara Euteneuer
Clinical Consensus Statement: Balloon Dilation of the Eustachian Tube. Otolaryngology, Head and Neck Surgery, 2019. Vol. 16 (I) 6-17. Debara L. Tucci, MD, MS, MBA, Edward D. McCoul, MD, MPH, Richard M. Rosenfeld, MD, MPH, MBA, David E. Tunkel, MD, Pete S. Batra, MD, Sujana S. Chandrasekhar, MD, Susan R. Cordes, MD, Adrien A. Eshraghi, MD, David Kaylie, MD, Devyani Lal, MD, Jivianne Lee, MD, Michael Setzen, MD, Raj Sindwani, MD, FRCSC, Charles A. Syms III, MD, MBA, Charles Bishop, AuD, PhD, CCC-A, Dennis S. Poe, MD, Maureen Corrigan, and Erin Lambie, MS, MPH
Eustachian tube dilation as a first line tool in the treatment of chronic otitis media in children. A clinically controlled, randomized, patient blinded, prospective trial.
This training video is intended to provide product information for Clinicians in the U.S.
Eustachian Tube with inflated TubaVent®.
TubaVent® Short: 3.28mm x 20 mm at 10 atm
2080-1236320-US
TubaVent® Short Wide: 4.94mm x 20 mm at 10 atm
2080-12364520-US
TubaInsert
2080-2045-US
TubaVent® Short Balloon Catheter
shown with TubaInsert
Disposable Inflation Device
2080-9030040-US

REFERENCE ARTICLES

1. Schröder, S., & Ebmeyer, J. (2018). Diagnosis and treatment of Eustachian tube dysfunction. HNO, 66, 155-166.

2. Satmis, M. C., & van der Torn, M. (2018). Balloon dilatation of the Eustachian tube in adult patients with chronic dilatory tube dysfunction: a retrospective cohort study. European Archives of Oto-Rhino-Laryngology, 275(2), 395-400.

3. Schroeder, S., Lehmann, M., Ebmeyer, J., Upile, T. & Sudhoff, H. (2015) Balloon Eustachian tuboplasty: a retrospective cohort study Clin. Otolaryngol., 40, 629-638.

4. Shan A, Ward BK, Goman A.M., et al. (2019) Prevalence of Eustachian Tube Dysfunction in Adults in the United States JAMA Otolaryngology Head Neck Surgery 145, no. 10: 974-975.

5. Ockermann, T., Reineke, U., Upile T., Ebmeyer, J. & Sudhoff, H. (2010). Balloon Dilatation Eustachian Tuboplasty: A Clinical Study. Laryngoscope 120(7), 1411-6.

6. Skevas, T., Dalchow, C. V., Euteneuer, S., Sudhoff, H., & Lehnerdt, G. (2018). Cervicofacial and mediastinal emphysema after balloon eustachian tuboplasty (BET): a retrospective multicenter analysis. European Archives of Oto-Rhino-Laryngology, 275(1), 81-87.

TUBAVENT® SPECIFICATIONS

ITEM PRODUCT NUMBER TECHNICAL DETAILS
TubaVent® Short Balloon Catheter 2080-1236320-US Working length 236 mm, balloon 3x20 mm at 6 atm
TubaVent® Short Wide Balloon Catheter 2080-12364520-US Working length 236 mm, balloon 4.5x20 mm at 6 atm
TubaInsert Insertion Device 2080-2045-US Type 45°, 10 pieces
Inflation Device 2080-9030040-US With 50 cm extension tube, syringe volume 30 cc

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ORDERING

A P.O. or Bryan Medical order form, with quantities and item numbers required. Email orders to sales@bryanmedical.net