ENT balloon dilation products

NuVent™ EM balloon sinus dilation system

<p>The NuVent™ EM sinus dilation system aids sinus dilation with Medtronic navigation for CRS treatment in adults 18+.</p>

Ordering information

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Indications, Safety, and WarningsIndications for useThe NuVent™ eustachian tube dilation balloon is indicated for use in patients 18 years and older who need treatment for persistent eustachian tube dysfunction.Contraindications Medical conditions that contraindicate the use of a Medtronic computer-assisted surgery system and its associated applications include any conditions which may contraindicate the medical procedure itself.Intended use The NuVent™ eustachian tube dilation balloon is intended to dilate the eustachian tube canal.ContraindicationsThe NuVent™ eustachian tube dilation balloon is contraindicated for use in a eustachian tube with an ipsilateral carotid artery that is dehiscent into the eustachian tube lumen or history of ipsilateral patulous eustachian tube.Warnings

Prior to use, examine the product and its packaging for damage, deterioration, and expired shelf life. Replace it with an unused system and contact Medtronic customer service.

Use a sterile handling technique to maintain sterile condition of devices.

Prior to surgery confirm the carotid artery is not dehiscent into the eustachian tube canal.

Only use the Medtronic-provided Inflator to inflate the eustachian tube balloon.

Do not inflate the balloon with air. Use sterile saline only.

Ensure air bubbles are removed during priming of the inflator.

Confirm connection of the inflator to the balloon handpiece to avoid over-tightening the connection, leaks, and low-pressure during balloon expansion.

Do not insert the balloon when resistance of unknown cause is present as damage to tissue, or carotid artery may occur.

Insert and remove balloon catheter in line with the eustachian tube canal to prevent tissue damage.

Maintain pressure in the balloon for 2 minutes, or a reduced level of therapeutic benefit may result.

Ensure the balloon is fully inserted into the eustachian tube prior to and during use. The visual marker on the balloon mainshaft at proximal end of the balloon should be near the opening of the eustachian tube.

Fully deflate the balloon prior to insertion and removal from the eustachian tube.

The product is single-use only and should be properly disposed of following use. Do not attempt to reuse.

The product is provided sterile and should not be re-sterilized. Re-sterilization may damage the integrity of the product.

Dispose of the used product following healthcare facility guidelines on proper disposal of contaminated materials.

PrecautionsAvoid contact between the balloon, sharp objects, and/or hot surfaces (for example, an endoscope light) to avoid damaging the balloon.

Features

How does it work?

Use the NuVent™ system seeker and StealthStation™ ENT or StealthStation FlexENT™ navigation systems to locate the drainage pathway and follow it into the sinus.^1,2
Inflate the seeker’s balloon to move tissue and bone blocking the sinus drainage path.

Medtronic sinus treatment technologies

The NuVent™ system for balloon sinus ostia dilation may be used when performing balloon sinus surgery with surgical navigation. Our wide range of sinus-focused products can help you treat a broad spectrum of sinus disease and sinus patients.

Plug-and-play with Medtronic ENT navigation
Pre-calibrated for the StealthStation™ ENT and StealthStation FlexENT™ navigation systems with proprietary AxiEM™ EM tracking for precise confirmation^1,2 of balloon seeker placement

Simple system for balloon sinus surgery
Only three parts: balloon sinus seeker, tubing, and inflator

Maxillary, sphenoid, and frontal designs

Four unique designs for the maxillary, sphenoid, and frontal (70° or 98°) sinus with three balloon diameter options.

Our balloons are designed after the commonly used ostium seekers. We added a balloon so you can locate and dilate the sinus ostia at the same time.

Safety features
Protective valve indicator to help prevent accidental over-inflation.³

This is the popped-out regulator, a safety feature on the NuVent™ EM balloon sinus dilation system.

Ordering information

CFN	Product name	Type	Diameter	Lenght	Quantity
1830517FRT70	5.0 mm NuVent™ EM balloon sinus dilation system 70	'70	5.0 mm	17.0 mm	1 each
1830617FRT70	6.0 mm NuVent™ EM balloon sinus dilation system 70	'70	6.0 mm	17.0 mm	1 each
1830717FRT70	7.0 mm NuVent™ EM balloon sinus dilation system 70	'70	7.0 mm	17.0 mm	1 each
1830517FRT	5.0 mm NuVent™ EM balloon sinus dilation system 98	'98	5.0 mm	17.0 mm	1 each
1830617FRT	6.0 mm NuVent™ EM balloon sinus dilation system 98	'98	6.0 mm	17.0 mm	1 each
1830717FRT	7.0 mm NuVent™ EM balloon sinus dilation system 98	'98	7.0 mm	17.0 mm	1 each
1830507MAX	5.0 mm NuVent™ EM balloon sinus dilation system maxillary	maxillary	5.0 mm	7.0 mm	1 each
1830607MAX	6.0 mm NuVent™ EM balloon sinus dilation system maxillary	maxillary	6.0 mm	7.0 mm	1 each
1830707MAX	7.0 mm NuVent™ EM balloon sinus dilation system maxillary	maxillary	7.0 mm	7.0 mm	1 each
1830517SPH	5.0 mm NuVent™ EM balloon sinus dilation system sphenoid	sphenoid	5.0 mm	17.0 mm	1 each
1830617SPH	6.0 mm NuVent™ EM balloon sinus dilation system sphenoid	sphenoid	6.0 mm	17.0 mm	1 each
1830717SPH	7.0 mm NuVent™ EM balloon sinus dilation system sphenoid	sphenoid	7.0 mm	17.0 mm	1 each

NuVent EM Sinus Dilation System IFU

Data On File. REF-24598 — Validation and Usability test reports, 13-09-24 and 2274-021
Data on file - Inflator Pressure Relief Feature Design Verification. 14-01-20

NuVent™ EM balloon sinus dilation system

Features

How does it work?

Medtronic sinus treatment technologies

Ordering information

United States

Customer Care Team