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TubaVent®

Balloon Dilation System for Eustachian Tube Dysfunction

Restoring Natural Eustachian Tube Function at its Core

Rhinology Instruments and Disposables for Every Procedure

The TubaVent® Balloon Dilation System by SPIGGLE & THEIS offers a gentle, patient-friendly solution for treating Eustachian Tube Dysfunction. 4.6% of the adult population in the U.S. suffers from Eustachian tube dysfunction (ETD).1 Eustachian Tube Balloon Dilation (ETBD) is the first-line interventional causal treatment of ETD.

Multiple studies have demonstrated that the TubaVent® Balloon Catheter successfully restores normal ear function, leading to high patient satisfaction rates.2,3 Since its launch in 2010 in Europe, TubaVent® has been used in over 150,000 cases worldwide, solidifying its role as a trusted solution for ETD treatment.

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

Designed with a unique, low-profile catheter, TubaVent® enhances patient safety without compromising clinical effectiveness - empowering ENT specialists to restore natural function with confidence.

TubaVent® Balloon Dilation System

Specifically designed to treat Eustachian tube dysfunction

  • Two balloon sizes

    3.28 mm and 4.94 mm 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

    TubaVent® has been used in over 150,000 cases since its 2010 launch in Europe

Product Brochure

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Quick Reference Guide

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Instructions For Use

TubaVent IFU
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TubaVent® Specifications

Product Number Technical Details
TubaVent® Short Balloon Catheter 2080-1236320-US Working length 236 mm, balloon 3.28 mm at 10 atm
TubaVent® Short Wide Balloon Catheter 2080-12364520-US Working length 236 mm, balloon 4.94 mm at 10 atm
TubaInsert® ONE 2080-3045-US
 Angled tip 45°
Inflation Device 2080-9030040-US With 50 cm extension tube, syringe volume 30 cc

Dr. Marta Sandoval
Otologist

1Shan A, Ward BK, Goman A.M., et al. (2019) Prevalence of Eustachian Tube Dysfunction in Adults in the United States JAMA Otoaryngology Head Neck Surgery 145, no. 10: 974-975.

2Schröder S, Lehmann M, Ebmeyer J, Upile T, Sudhoff H. Balloon Eustachian tuboplasty: a retrospective cohort study. Clin Otolaryngol. 2015 Dec;40(6):629-38. doi: 10.1111/coa.12429. PMID: 25867023.

3Clinical Affairs SPIGGLE & THEIS Medizintechnik GmbH: Knuth, J. and Warnking, K., Balloon Eustachian Tube Dilatation as the Standard Causal Intervention for Eustachian Tube Dysfunction?! A summary of published clinical research; Whitepaper 2022

Eustachian tube with inflated TubaVent®

TubaVent® short: 3.28 mm at 10 atm
2080-1236320-US

TubaInsert® ONE
2080-3045-US

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Understanding Obstructive Eustachian Tube Dysfunction (ETD)

Obstructive Eustachian Tube Dysfunction (ETD) is a common condition that occurs when the Eustachian tube cannot open properly to ventilate the middle ear. The Eustachian tube connects the middle ear to the nasopharynx and plays a critical role in pressure equalization, drainage of middle ear secretions, and overall ear health.

When the Eustachian tube becomes blocked or fails to function normally, patients may experience chronic ear pressure, ear fullness, muffled hearing, popping sensations, discomfort during air travel, or difficulty equalizing pressure changes. Persistent ETD can significantly affect quality of life and may contribute to recurrent middle ear problems.

Studies suggest that approximately 4.6% of adults in the United States are affected by Eustachian Tube Dysfunction, making it one of the most common disorders of middle ear ventilation. For many patients, symptoms persist despite medical management and require further evaluation by an otolaryngologist (ENT specialist).

What Causes Obstructive Eustachian Tube Dysfunction?

Several factors may contribute to obstructive ETD, including:

  • Chronic inflammation of the Eustachian tube
  • Allergic rhinitis
  • Upper respiratory infections
  • Sinus disease
  • Anatomical narrowing of the Eustachian tube
  • Chronic mucosal swelling
  • Environmental pressure changes

These factors can interfere with the normal opening mechanism of the Eustachian tube and prevent effective middle ear ventilation.

Common Symptoms of ETD

Patients with obstructive Eustachian Tube Dysfunction frequently report:

  • Chronic ear pressure
  • Ear fullness or blockage
  • Muffled hearing
  • Clicking or popping sounds
  • Difficulty equalizing pressure during flights
  • Discomfort during altitude changes
  • Recurrent middle ear fluid
  • Hearing fluctuations
  • Persistent ear discomfort

Because these symptoms can overlap with other ear disorders, a comprehensive ENT evaluation is important to establish an accurate diagnosis.

Balloon Eustachian Tuboplasty (BET)

Balloon Eustachian Tuboplasty (BET) has become an established minimally invasive treatment option for patients with persistent obstructive ETD. During the procedure, a specialized balloon catheter is introduced into the cartilaginous portion of the Eustachian tube and inflated for a controlled period of time.

The goal of Eustachian Tube Balloon Dilation is to improve the function of the Eustachian tube, restore natural pressure equalization, and support normal middle ear ventilation. Multiple clinical studies have demonstrated that Balloon Eustachian Tuboplasty can provide meaningful symptom improvement and high patient satisfaction in appropriately selected patients.

The Importance of Balloon Size and Controlled Dilation

Recent research has highlighted the importance of selecting appropriate balloon dimensions during Eustachian Tube Balloon Dilation procedures. Excessive dilation may increase the risk of unwanted symptoms associated with Patulous Eustachian Tube Dysfunction, a condition in which the Eustachian tube remains abnormally open.

The TubaVent® Balloon Dilation System was specifically developed to provide a gentle and patient-friendly approach to Balloon Eustachian Tuboplasty. By utilizing smaller balloon diameters and a flexible balloon design, TubaVent® supports controlled dilation while helping physicians address persistent obstructive Eustachian Tube Dysfunction.

Restoring Natural Eustachian Tube Function

Successful treatment of obstructive ETD focuses on restoring the natural physiological function of the Eustachian tube. Improved pressure equalization, better middle ear ventilation, and reduction of chronic symptoms can help patients return to normal daily activities with greater comfort and confidence.

For ENT physicians seeking a dedicated solution for Eustachian Tube Balloon Dilation, the TubaVent® Balloon Dilation System provides a clinically established platform specifically designed for the treatment of persistent obstructive Eustachian Tube Dysfunction.

Frequently Asked Questions About the TubaVent® Balloon Dilation System

  • What is the TubaVent® Balloon Dilation System?
     TubaVent® is a balloon catheter system specifically designed for Balloon Eustachian Tuboplasty (BET) procedures in patients with persistent obstructive Eustachian Tube Dysfunction (ETD). The system combines a flexible balloon catheter with dedicated insertion and inflation components to support controlled Eustachian tube dilation.

  • How does TubaVent® differ from conventional Eustachian tube balloon systems?
    TubaVent® was specifically designed to provide a gentle and patient-friendly approach to Eustachian tube dilation. The system utilizes smaller balloon diameters than many conventional devices and incorporates features that support precise placement and controlled dilation.

  • Why does TubaVent® use smaller balloon diameters?
    Research has suggested that larger balloon diameters may increase the risk of unwanted symptoms associated with over-dilation. TubaVent® offers smaller balloon sizes designed to provide effective dilation while supporting a conservative treatment approach.

  • What balloon sizes are available with TubaVent®?
    TubaVent® is available with balloon diameters of approximately 3.0 mm and 4.5 mm and a balloon length of 20 mm. These sizes allow physicians to select an appropriate treatment option based on patient anatomy and clinical judgment.

  • What is the purpose of the olive-shaped tip?
    The olive-shaped tip was designed to facilitate atraumatic insertion and provide enhanced protection of the Eustachian tube mucosa during catheter placement.

  • What is TubaInsert® ONE?
    TubaInsert® ONE is the dedicated insertion device used with the TubaVent® Balloon Dilation System. It enables controlled advancement of the balloon catheter and supports accurate positioning during the procedure.

  • What are the advantages of one-handed insertion?
    The TubaInsert® ONE system allows physicians to operate the insertion device with one hand, providing improved control during catheter advancement and positioning while leaving the other hand free for endoscopic visualization or instrument handling.

  • How does the black safety marking improve placement?
    The inserter incorporates a black visual safety marking that assists physicians in confirming proper tip positioning during insertion and helps support safe catheter placement.

  • What is the benefit of the flexible balloon design?
    The flexible balloon catheter is designed to facilitate precise positioning within the Eustachian tube while supporting controlled dilation of the target treatment area.

  • Can TubaVent® be used for bilateral procedures?
    Yes. The TubaInsert® ONE system was designed to support bilateral use, allowing treatment of either Eustachian tube during the procedure.

  • How many TubaVent® procedures have been performed worldwide?
    Since its introduction in Europe in 2010, TubaVent® has been used in more than 150,000 procedures worldwide, providing extensive clinical experience across a broad range of patients.

  • Is Balloon Eustachian Tuboplasty supported by clinical evidence?
    Multiple clinical studies have evaluated Balloon Eustachian Tuboplasty as a treatment for persistent obstructive Eustachian Tube Dysfunction. Published research has demonstrated improvements in Eustachian tube function and high levels of patient satisfaction following treatment.

  • Which physicians typically perform TubaVent® procedures?
    TubaVent® procedures are typically performed by otolaryngologists (ENT physicians) with experience in Eustachian tube disorders and endoscopic ENT procedures.

  • What components are included in the TubaVent® Balloon Dilation System?
    The system consists of the TubaVent® Balloon Catheter, the TubaInsert® ONE insertion device, and a dedicated inflation device designed to provide controlled balloon inflation during Balloon Eustachian Tuboplasty procedures.

  • Where can physicians obtain additional information about TubaVent®?
    Detailed product specifications, instructions for use, procedural information, and technical documentation are available through Bryan Medical and official TubaVent® product resources.