Sam Brusco, Associate Editor12.01.22
WISE Srl, a company developing implantable electrodes for neuromonitoring, neuromodulation, and brain-machine interfacing (BMI), has earned U.S. Food and Drug Administration (FDA) clearance for its WISE Cortical Strip (WCS).
The single-use WCS is used on the brain surface for intraoperative neurophysiological monitoring (IONM). It’s the first produce to gain FDA clearance in the company’s WISEneuro Monitoring product family.
A European study showed the WISE Cortical Strip performed better in terms of electrical impedance in physiological conditions than conventional cortical electrodes, as well as better adhesion, conformability, and stability on the brain’s surface.
WCS is used intraoperatively with recording, monitoring, and stimulation equipment. It’s composed of stretchable platinum contacts embedded in a soft, think silicone film—unlike the stiff metal discs enclosed in thick silicone foil like traditional contact electrodes.
The company now aims to expand its WISEneuro Monitoring portfolio, which will comprise strips and grids with varying thickness and embedded contacts in a range of shapes, density, numbers, or sizes. WISE will also work to complete development of its Heron lead for spinal cord stimulation (SCS), an expandable percutaneous paddle lead for pain therapists and neurosurgeons.
Luca Ravagnan, CEO of WISE told the press, “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 U.S.”
The single-use WCS is used on the brain surface for intraoperative neurophysiological monitoring (IONM). It’s the first produce to gain FDA clearance in the company’s WISEneuro Monitoring product family.
A European study showed the WISE Cortical Strip performed better in terms of electrical impedance in physiological conditions than conventional cortical electrodes, as well as better adhesion, conformability, and stability on the brain’s surface.
WCS is used intraoperatively with recording, monitoring, and stimulation equipment. It’s composed of stretchable platinum contacts embedded in a soft, think silicone film—unlike the stiff metal discs enclosed in thick silicone foil like traditional contact electrodes.
The company now aims to expand its WISEneuro Monitoring portfolio, which will comprise strips and grids with varying thickness and embedded contacts in a range of shapes, density, numbers, or sizes. WISE will also work to complete development of its Heron lead for spinal cord stimulation (SCS), an expandable percutaneous paddle lead for pain therapists and neurosurgeons.
Luca Ravagnan, CEO of WISE told the press, “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 U.S.”