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# FDA Approves Medtronic Brain Stimulator for Seizures
- URL: https://www.fdaweb.com/fda-approves-medtronic-brain-stimulator-for-seizures/
- Published: 2018-05-01T12:00:00.000Z
- Updated: 2026-09-15T00:02:14.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5141335

FDA has approved a Medtronic PMA for its Deep Brain Stimulation (DBS) therapy as adjunctive treatment for reducing the frequency of partial-onset seizures, in individuals 18 years of age or older who are refractory to three or more antiepileptic medications. “DBS therapy for epilepsy delivers controlled electrical pulses to a target in the brain called the anterior nucleus of the thalamus (ANT), which is part of a network involved in seizures,” the company says.

Approval was based on both the blinded phase and the seven-year follow-up data collected in Medtronic’s SANTE (Stimulation of the Anterior Nucleus of the Thalamus in Epilepsy) clinical trial. Those data were collected from 110 patients who were implanted with a Medtronic DBS system at 17 centers located in the U.S. The data showed that the median total seizure frequency reduction from baseline was 40.4% versus 14.5% for the placebo group at three months, and 75% at seven-years, with open-label ongoing therapy.