| Developers: | WISE Srl |
| Date of the premiere of the system: | May 2021 |
| Branches: | Pharmaceuticals, Medicine, Healthcare |
Content |
2022: Start of production
On December 1, 2022, the Italian company Wise announced the release of the Wise Cortical Strip system for intraoperative neurophysiological monitoring.
Wise has confirmed the performance of Wise Cortical Strip in a clinical study conducted in several European clinics during the pre-market period, the device already has a CE certificate received in May 2021.
The study demonstrated the safety, efficacy and usability of the product. Wise Cortical Strip also demonstrated higher electrical resistance performance under physiological conditions compared to conventional cortical electrodes on the market. According to the developers, it also demonstrated better adhesion, adjacency and stability on the surface of the brain.
{{quote 'Obtaining permission FDA is an important milestone for our commercial development, enabling the expansion of the Wise Cortical Strip from Europe to the US and driving the development of the WiseNeuro monitoring product family. European clinicians are already showing a high appreciation for the benefits of our product, and we look forward to commercializing in the US as well, "said Wise CEO Luca Ravagnan. }} Wise Cortical Strip works intraoperatively with recording, monitoring and stimulation equipment. The device is a different offering from traditional cortical electrodes made from hard metal discs in thick silicone film. Stretchable platinum contacts are embedded in soft and thin film. This makes it very ergonomic and comfortable on the surface of the brain. The company in 2023 intends to expand the family of monitoring products and develop the Heron conductor for stimulating the spinal cord.[1]
2021: Implant announcement for continuous monitoring of brain function
At the end of May 2021, medical device manufacturer WISE Srl released a single-use WISE Cortical Strip (WCS) device designed for intraoperative monitoring of brain function. The results of clinical studies conducted in several medical centers demonstrated the safety, performance and usability of the WISE device, as well as its advantages over other traditional cortical electrodes.
The WISE cortical electrode can be used to both stimulate and record the electrical activity of the brain, allowing its activity to be monitored during brain tumor resection or treatment of epileptogenic lesions. Unlike traditional cortical electrodes, which are made of hard metal discs encased in thick silicone foil, the WISE Cortical Strip consists of stretchable platinum contacts encased in soft, thin silicone film.
During operations, the cortical electrode allows monitoring the functional integrity of nerve circuits to minimize neurological damage during resection of lesions. However, since the surface of the brain is curved and represents ridges and grooves, only ergonomic electrodes of the desired shape, such as WISE Cortical Strip, can fully fit the entire surface of the brain and control its functional integrity.
The special WISE technology allows the development of thin, flexible and flexible electrodes that provide effective stimulation and recording of brain activity. In addition to neuromonitoring, WISE is also active in the field of neuromodulation, developing the WISEneuro Modulation family of products. The first product of this line will be the SCS Expert electrode for percutaneous stimulation of the spinal cord, which neurosurgeons will be able to use to anesthetize patients with chronic diseases.[2]
Notes
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