Medtronic has received European regulatory approval for its Activa PC deep brain stimulation therapy system for patients with refractory (drug resistant) epilepsy. The same family of neurostimulators already has EU and US approvals for essential tremor and advanced Parkinson’s.
The CE Mark approval was based on data collected in Medtronic’s clinical trial called SANTÉ® (Stimulation of the Anterior Nucleus of the Thalamus in Epilepsy). The SANTÉ 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. The trial collected data from 110 patients who were implanted with a Medtronic DBS system at 17 U.S. centers. Long-term data from the study were presented at American Epilepsy Society (AES) meetings in December 2008 and 2009, and were published in the journal, Epilepsia, in March 2010. Based on the CE Mark, Medtronic will be introducing its DBS Therapy for Epilepsy in expert epilepsy centers across Europe by the end of the year.
Medtronic DBS Therapy for refractory epilepsy is investigational in the United States and is under review by the U.S. Food and Drug Administration (FDA). FDA recently requested additional data to support Medtronic’s premarket approval (PMA) application, which will require further clinical study.
Press release: Medtronic Receives European CE Mark Approval for Deep Brain Stimulation Therapy for Refractory Epilepsy…
Product page: Activa PC Deep Brain Neurostimulator…
Flashbacks: Medtronic’s DBS Therapy for Epilepsy May Yet Get FDA Approval; Medtronic to Seek FDA Approval of Brain Stimulation Device for Epilepsy; Promising Results Released in Controlling Epilepsy via Deep Brain Stimulation