Wise, a company that develops next-generation implantable electrodes for neuromonitoring, neuromodulation and brain-machine interfacing applications, has announced the US Food and Drug Administration (FDA) clearance of its Wise Cortical Strip (WCS)—a single-use medical device intended to be used on the brain’s surface for intraoperative neurophysiological monitoring.
The WCS is the first product to receive FDA clearance within the company’s WISEneuro monitoring product family. This FDA clearance also follows the product being awarded a CE mark back in May 2021.
The performances of the WCS have been successfully validated in a multicentre, premarket clinical study in Europe—the WIN study—where it demonstrated safety, performance and usability. According to a Wise press release, this study showed better performances with the WCS in terms of electrical impedance in physiological conditions as compared to conventional cortical electrodes available on the market, as well as better adhesion, conformability and stability on the brain surface.
The WCS is intended for intraoperative use with recording, monitoring and stimulation equipment for the recording, monitoring, and stimulation of electrical signals on the brain’s surface. And, unlike traditional cortical electrodes, which are made of stiff metal discs enclosed in a thick silicone foil, it is composed of stretchable platinum contacts embedded in a soft, thin film of silicone—making the WCS “highly ergonomic and conformable to the brain surface”.
After the successful FDA clearance of the device, Wise is now aiming to expand its WISEneuro monitoring product family to comprise strips and grids with varying thickness, with embedded contacts of a wide range of shapes, density, numbers or sizes, in addition to completing the development of its Heron lead for spinal cord stimulation (SCS). The company claims the Heron SCS lead is 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 [us] to expand the distribution of the WCS from Europe to the USA, and fuelling the development of the WISEneuro monitoring product family. European clinicians are already demonstrating strong appreciation for the benefits of our product, [and] we are looking forward to starting commercialisation also in the USA.”