Wise Cortical Strip for Intraoperative Neurophysiological Monitoring
The WIN Study is a prospective, interventional, multi-center, open-label premarket study
designed to confirm the safety, performance and intended use of the Wise Cortical Strip (WCS)
for CE certification purposes. Participants with documented diagnosis of epilepsy or brain
tumor requiring intracranial surgery, who meet all eligibility criteria, will undergo
IntraOperative Neurophysiological Monitoring (IONM) during a neurosurgical intervention with
the WCS and a comparator device (Subdural Strip Electrode, Ad-Tech Medical Instruments
Corporation, Racine, Wisconsin, USA).
The WCS is a single use medical device intended for intraoperative...