06.15.15
The U.S. Food and Drug Administration (FDA) has given Electrical Geodesics Inc. (EGI) approval to conduct a clinical safety and efficacy evaluation of its GTEN neuromodulation device as a treatment for managing epilepsy. Data generated by the data will be used to support a 510(k) submission, the Eugene, Ore., devicemaker said.
The Geodesic Transcranial Electrical Neuromodulation device is latest addition to the firm’s GES 400 dense-array EEG platform. The device will use Electrical Geodesics’ head modeling technology to determine the areas of the brain where treatment should be focused and, once that area is pinpointed, deliver small amounts of targeted electrical current to the focal area, the company said. The device and software will then deliver small amounts of highly targeted electrical current through a changing pattern of the devices 256 electrodes in order to direct treatment to the focal area and spare treatment to non-target areas. During and after treatment the same device and electrodes can record brain activity to monitor the safety and effect of the product.
In time, seizures can move to multiple sources. Whilst the frequency and severity of seizures varies, epilepsy is characterized by more frequent small electrical discharges or inter-ictal spikes, the incidence of which is used by clinicians to assess and treat patients. Most brain neuromodulation devices are contra-indicated in epilepsy, with the concern that seizures might be induced rather than modulated or reduced, but research evidence has shown that well-directed magnetic or electrical stimulation can reduced the incidence of inter-ictal spikes.
“For some years we have had a strong belief in the potential of dense array electrical neuromodulation as a treatment in intractable neurological conditions and see it as a natural extension of our expertise in the monitoring and imaging of brain activity," said EGI CEO Don Tucker. "Our current GES 400 platform was designed to allow the flexibility to both measure and deliver targeted electrical currents and we are pleased the inherent safety offered by our ability to monitor the effect of treatment as it is delivered has given the FDA confidence to allow us to study GTEN in epilepsy. The neuromodulation market is booming and we are hugely excited about the potential for GTEN initially as a driver of research sales and later as an important clinical tool.”
The initial trial will enroll about 20 patients at two study sites, 25 percent or more or whom are refractory or resistant to drug treatment and whose seizures result from electrical discharges. That trial will be followed by pivotal studies, the company said.
Founded in 1992, Electrical Geodesics develops dense array electroencephalography (dEEG) technology used in human neuroscience research laboratories worldwide. The company is based in Eugene, Ore.
The Geodesic Transcranial Electrical Neuromodulation device is latest addition to the firm’s GES 400 dense-array EEG platform. The device will use Electrical Geodesics’ head modeling technology to determine the areas of the brain where treatment should be focused and, once that area is pinpointed, deliver small amounts of targeted electrical current to the focal area, the company said. The device and software will then deliver small amounts of highly targeted electrical current through a changing pattern of the devices 256 electrodes in order to direct treatment to the focal area and spare treatment to non-target areas. During and after treatment the same device and electrodes can record brain activity to monitor the safety and effect of the product.
In time, seizures can move to multiple sources. Whilst the frequency and severity of seizures varies, epilepsy is characterized by more frequent small electrical discharges or inter-ictal spikes, the incidence of which is used by clinicians to assess and treat patients. Most brain neuromodulation devices are contra-indicated in epilepsy, with the concern that seizures might be induced rather than modulated or reduced, but research evidence has shown that well-directed magnetic or electrical stimulation can reduced the incidence of inter-ictal spikes.
“For some years we have had a strong belief in the potential of dense array electrical neuromodulation as a treatment in intractable neurological conditions and see it as a natural extension of our expertise in the monitoring and imaging of brain activity," said EGI CEO Don Tucker. "Our current GES 400 platform was designed to allow the flexibility to both measure and deliver targeted electrical currents and we are pleased the inherent safety offered by our ability to monitor the effect of treatment as it is delivered has given the FDA confidence to allow us to study GTEN in epilepsy. The neuromodulation market is booming and we are hugely excited about the potential for GTEN initially as a driver of research sales and later as an important clinical tool.”
The initial trial will enroll about 20 patients at two study sites, 25 percent or more or whom are refractory or resistant to drug treatment and whose seizures result from electrical discharges. That trial will be followed by pivotal studies, the company said.
Founded in 1992, Electrical Geodesics develops dense array electroencephalography (dEEG) technology used in human neuroscience research laboratories worldwide. The company is based in Eugene, Ore.
