Milan, Italy-based Wise designed the single-use medical device for use on the brain surface in IONM.
According to a news release, it marks the first product to receive FDA clearance within the WiseNeuro monitoring product family. It already holds CE mark approval, having garnered that in May 2021.
Wise validated the WCS in a multi-clinic, pre-market clinical study in Europe. The study demonstrated the safety, performance and usability of the product. It also demonstrated stronger performance in terms of electrical impedance in physiological conditions compared to conventional cortical electrodes available on the market.
The company said it also showed better adhesion, conformability and stability on the brain surface.
WCS works intraoperatively with recording, monitoring and stimulation equipment. It represents a different offering from traditional cortical electrodes made of stiff metal discs in a thick silicone foil. The stretchable platinum contacts embedded in a soft and thin film. This makes it highly ergonomic and comfortable on the brain surface.
“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 U.S. and fueling the development of the WiseNeuro monitoring product family,” said Wise CEO Luca Ravagnan. “European clinicians are already demonstrating strong appreciation for the benefits of our product, we are looking forward to starting commercialization also in the U.S.”
Wise now aims to expand its monitoring product family and develop its Heron lead for spinal cord stimulation, it said.