Electrical Geodesics Nabs IDE for Neuromodulation Device

The FDA has given Electrical Geodesics a green light 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 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. — Kellen Owings