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 refer to each product’s Instructions For Use, provided witheach product or contact the customer service. Rx only.
VenSure, Cube, and VirtuEye have pending trademark applications in the US. ©2022 Fiagon NA, LLC. All rights reserved.