December 2, 2022
1 minute read
WISE Srl, a medical device company, has announced that it has received FDA approval for its Cortical Strip, a single-use device intended to be used on the brain surface for intraoperative neurophysiological monitoring.
According to the company’s release, the new device is the first to receive FDA approval within the product family and follows the European CE mark that the product received back in May 2021.
The WISE Cortical Strip is intended for intraoperative use with recording, monitoring and stimulation equipment to record, monitor and stimulate electrical signals at the brain surface, according to the release. Unlike traditional cortical electrodes, which are made of rigid 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, the company said.
“FDA approval is a critical milestone for our commercial development [us] to expand distribution of the WISE Cortical Strip from Europe to the US and drive development of the WISEneuro Monitoring family of products,” Luca Ravagnan, CEO of WISE mentioned in the release. “European clinicians are already showing great appreciation for the benefits of our product; we look forward to starting commercialization in the US as well”
The performance of the cortical strip has been successfully validated in a multicentre premarket clinical trial in Europe, the WIN trial, which demonstrated the safety and utility of the product. The company further revealed in the release that a study is presented Clinical Neurophysiology showed that the WISE Cortical Strip performed better in terms of electrical impedance in physiological conditions than conventional cortical electrodes available on the market; the strip also showed better adhesion, conformability and stability to the brain surface.