1830717FRT70

NuVent™ EM balloon sinus dilation system

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.

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