Device Dossier

WISE CORTICAL STRIP - Electrode, cortical

Device Dossier for WISE CORTICAL STRIP - Electrode, cortical (Electrode, cortical, Class III, sponsor RQSolutions Medical Devices Distribution Support).…

Intended purpose

The Medical Device is intended for patients requiring IntraOperative Neurophysiological Monitoring (IONM) during resection of brain tumors or epileptogenic lesions.

Functional description

The Medical Device records brain’s spontaneous electrical activity (ECoG, ElectroCorticoGraphy) and Somatosensory Evoked Potentials (SEPs) and used for Brain stimulation, aimed to elicit Motor Evoked Potentials (MEPs).

TGA Public Summary