NuVent EM Balloon Sinus Dilation System

Indications, Safety, and Warnings

This website provides excerpts from our user manuals. It is important to consult the full system manuals for the most updated information.

NuVent EM Sinus Dilation System

Indications

The NuVent™ EM Sinus Dilation System is intended for use in sinus procedures when surgical navigation or image-guided surgery may be necessary to locate and move tissue, bone, or cartilaginous tissue surrounding the drainage pathways of the frontal, maxillary, and sphenoid sinuses.

The EM Sinus Dilation System is used in conjunction with the Medtronic computer-assisted surgery system.

The Medtronic computer-assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT- or MR-based model, or digitized landmarks of the anatomy.

The system and its associated applications should be used only as an adjunct for surgical guidance. They do not replace the surgeon's knowledge, expertise, or judgment.

Contraindications

None known.

Warnings and Precautions

• The sinus seekers are fixed, rigid instruments that are not designed to bend. Do not bend or alter the instrument, as navigational inaccuracy will occur.
• Do not open sterile barrier packages or containers until surgical use.
• Deflate balloon prior to removal from anatomy.
• Only use device in conjunction with an endoscope.
• Only use sterile saline as inflation solution.
• Do not reuse the seeker or inflator, as these are single patient use devices.
• Do not submerge the sinus seeker.
• Only use the sinus seeker in conjunction with Medtronic Inflator part number 18INFKIT.
• Do not place metal objects in magnetic field.
• Do not use the sinus seeker to perforate thick bone.
• Use of the incorrect balloon size may cause damage to the sinus balloon and/or surrounding anatomy.
• Use of an undersized sinus balloon may result in failure to properly treat the target sinus.
• Prior to use, examine the product packaging for damage, deterioration, and expired shelf life. Replace it with an unused system and contact Medtronic Technical Service.
• Only use device in conjunction with Medtronic computer-assisted surgery system.
• You must re-register the patient if you replace the EM ENT Patient Tracker during any part of the procedure.
• Do not hold the seeker at the proximal end of the handle or apply excessive force to the handle, as this may cause navigational inaccuracy.