Medtronic has received CE (Conformite Europeenne) mark for Deep Brain Stimulation (DBS) Therapy in Europe as adjunctive treatment for partial-onset seizures in adults with medically refractory epilepsy.
Medtronic said that DBS therapy for epilepsy delivers controlled electrical pulses to the anterior nucleus of the thalamus in the brain, which is part of a circuit involved in seizures.
The CE mark approval was based on data collected in Medtronic’s SANTE (Stimulation of the Anterior Nucleus of the Thalamus in Epilepsy) clinical trial.
The SANTE trial was a prospective, randomized, double-blind pivotal study to evaluate the use of DBS therapy for patients with medically refractory epilepsy with partial-onset seizures.
Medtronic Neuromodulation business unit senior vice president and president Tom Tefft said that this CE mark is the first approval by a regulatory agency for the use of DBS therapy in severe epilepsy and provides a new treatment option for patients in Europe who are in need of other options.
“In the US, we remain committed to working with FDA to determine the most appropriate path forward,” Tefft said.