The VenSure Nav Balloon Device is intended for use in conjunction with the Cube Navigation System during 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 frontal, maxillary, and sphenoid sinuses to facilitate dilation of the sinus ostia. The Cube Navigation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure can be identified relative to a CT or MR based model of the anatomy. The navigation system must not be used in patients with electronic devices in direct connection to the brain or the nervous system such as implantable neurostimulators, programmable CSF shunts or with monopolar pacemakers (older designs, with lower resistance to interference) or ICD’s. For full listing of indications, contraindications, warnings and precautions and adverse effects, please see each product’s Instructions For Use: fiagon.com/us/company/instructions-for-use. Rx only.
Intersect ENT is a registered trademark of Intersect ENT, Inc. in the US and other countries. VenSure, Cube, and VirtuEye have pending trademark applications in the US. ©2021 Intersect ENT, Inc. All rights reserved. MPM-12144 Rev 2.0