INSTRUCTIONS FOR USE (IFU)

NeuroBlate System

Monteris provides technology for neurosurgeons, which allows them to ablate (destroy with heat), brain structures such as brain tumors, radiation necrosis, and epileptic foci. Monteris technology includes the NeuroBlate System, AtamA, and MiniBolt devices, which may be used together to apply the focused laser energy with little or no effect on surrounding healthy tissue. The NeuroBlate System provides clinicians a tool that offers near real-time control and MRI visualization of the therapy during laser ablation treatment.

All brain surgeries carry risk. Possible adverse events include, but are not limited to, hematoma, embolic events, edema, bleeding, cerebral spinal fluid (CSF) leakage, infection, unintended major tissue damage and permanent neurological deficits. Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions and potential adverse events.

Rx Only.