The Wise Cortical Strip (WCS) is a single use medical device for IntraOperative Neurophysiological Monitoring (IONM) during brain tumour and epilepsy surgeries.
The WCS is used for continuous recording of the brain’s spontaneous electrical activity (ECoG) and somatosensory evoked potentials (SEPs) and for brain stimulation, aimed to elicit motor evoked potentials (MEPs).
The WCS is manufactured with WISE’s proprietary and patented Supersonic Cluster Beam Implantation (SCBI). The SCBI technology allows to produce devices with highly improved physicochemical properties regarding their strength, conformability and rigidity.
Whereas traditional cortical strips are made of a stiff plate of stable shape, the WCS is composed of platinum electrodes embedded in a soft and thin film of silicone. The WCS is therefore highly ergonomic and conformable even on surfaces, such as the brain, with a floppy nature. These properties improve the adhesion and adaptability of the electrode’s contacts on the cortical surface.
Thanks to WISE’s innovative manufacturing technology, the Wise Cortical Strip allows extremely precise monitoring of the brain activity, featuring the following characteristics:
Pre-clinical studies have proven the WCS functionality, performance, reliability, stability, biocompatibility, safety and usability, making the device suitable to be used in a clinical context for IntraOperative Neurophysiological Monitoring (IONM).
The WCS is not yet a legally marked device. A multicentric pre-market clinical study is starting in Europe to confirm the safety, performance and usability of WCS during surgical interventions and to collect data for CE purposes. The study will end in summer 2019.