MILAN– WISE Srl, a medical device company developing next-generation implantable electrodes for neuromonitoring, neuromodulation and brain-machine interfacing (BMI), today announced the FDA clearance (K221123) of its WISE Cortical Strip (WCS®), a single use medical device intended to be used on the brain surface for Intra Operative Neurophysiological Monitoring (IONM).
The WISE Cortical Strip is the first product receiving FDA clearance within the Company’s WISEneuro® Monitoring product family. The FDA clearance follows the CE mark already received by the product in May 2021.
The WISE Cortical Strip performances have been successfully validated in a multicentric pre-market clinical study in Europe, the WIN study (NCT03731455), that demonstrated safety, performance and usability of the product. The study showed that the WISE Cortical Strip has better performance in terms of electrical impedance in physiological conditions than conventional cortical electrodes available on the market, as well as better adhesion, conformability and stability on the brain surface. The WIN study data was recently published on the journal Clinical Neurophysiology.
The WISE Cortical Strip is intended for intraoperative use with recording, monitoring and stimulation equipment for the recording, monitoring, and stimulation of electrical signals on the brain surface. Unlike traditional cortical electrodes, which are made of stiff metal discs enclosed in a thick silicone foil, the WISE Cortical Strip is composed of stretchable platinum contacts embedded in a soft and thin film of silicone. As a result, the WISE Cortical Strip is highly ergonomic and conformable to the brain surface.
After the successful FDA clearance of the device, the Company is now aiming to expand its WISEneuro® Monitoring product family, that will comprise strips and grids with varying thickness, and with embedded contacts of a wide range of shapes, density, numbers or sizes, and to complete the development of its Heron® lead for Spinal Cord Stimulation (SCS), the first expandable percutaneous paddle lead that pain therapists and neurosurgeons will be able to implant percutaneously.
Luca Ravagnan, CEO of WISE said: “The FDA clearance is a crucial milestone for our commercial development, allowing to expand the distribution of the WISE Cortical Strip from Europe to the US and fueling the development of the WISEneuro® Monitoring product family. European clinicians are already demonstrating strong appreciation for the benefits of our product, we are looking forward to starting commercialization also in the US.”
