Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
Neurological devices panel: FDA's neurological devices advisory panel will meet Nov. 20 to vote on a PMA for Medtronic's deep brain stimulation system for treating epilepsy. The device is intended as an adjunct to drugs for reducing the frequency of seizures in patients with drug-refractory epilepsy with partial-onset seizures. Medtronic announced in July it had filed the PMA, supported by data from a trial showing reduced seizure frequency in the DBS group compared to patients taking medication alone (1"The Gray Sheet" July 20, 2009). Medtronic has marketed the Activa DBS system for Parkinson's and essential tremor for more than a decade and also recently gained an humanitarian device exemption for obsessive-compulsive disorder DBS therapy and is pursuing a depression indication