Medical devices maker WISE has started patient enrolment in the pivotal WIN Study being conducted to assess its neuro-electrodes for brain monitoring.
Based on the company’s Supersonic Cluster Beam Implantation (SCBI) technology, the neuromonitoring and neuromodulation electrodes have been embedded into a medical device dubbed WISE Cortical Strip.
WISE Cortical Strip is made of flexible platinum electrodes integrated with a soft, thin film of silicone. This is said to address the stiffness and rigidity associated with conventional cortical strips.
It features metallisation technology to allow insertion of stretchable and pliable electronic microcircuits into biocompatible silicones, thereby enabling better adhesion to the brain surface, minimal invasion and improved adaptability.
The device is designed for continuous recording of electrical activity and stimulation of the brain. It is intended to facilitate intraoperative neurophysiological monitoring during brain tumour and epilepsy surgeries.
WIN Study will assess the safety, performance and intended use of the Wise Cortical Strip in epilepsy or brain tumour patients who need intracranial surgery.
The prospective, interventional, multi-centre, open-label premarket study will enrol about 33 participants across four clinical centres in Germany and Switzerland.
The first patient has been recruited at Universitätsspital Zürich, Switzerland.
WISE CEO Dr Luca Ravagnan said: “Initiating the pivotal study of our WISE Cortical Strip is a key milestone for us as we work towards CE approval and commercialisation.
“Patient enrolment is on schedule and we look forward to feedback from the surgeons on ease of use and low electrical impedance.”
Primary outcome measures of the study are serious adverse device effects and signal-to-noise ratio percentage, while secondary outcomes include impedance values, motor evoked potentials and usability questionnaire.
The study is expected to be completed in the third quarter of this year.