Medtronic Aims For Epilepsy DBS Implant Approval By Summer
This article was originally published in The Gray Sheet
Executive Summary
Medtronic is aiming for PMA approval of its deep brain stimulation implant for epilepsy by next summer, despite a recent delay in a scheduled FDA advisory panel review of the device
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Neuro Panel Narrowly OKs Medtronic's Deep Brain Stim Device For Epilepsy
Medtronic's deep brain stimulation device designed to treat epilepsy gained the support of FDA's Neurological Devices Panel March 12 with a 7-5 vote in favor of PMA approval
Neuro Panel Narrowly OKs Medtronic's Deep Brain Stim Device For Epilepsy
Medtronic's deep brain stimulation device designed to treat epilepsy gained the support of FDA's Neurological Devices Panel March 12 with a 7-5 vote in favor of PMA approval
Regulatory News In Brief
Medtronic epilepsy device gets new panel date: FDA's neurological devices advisory panel will review a pre-market approval application for Medtronic's deep brain stimulation implant for epilepsy on March 12, after a November 2009 panel review of the device was postponed. The device is intended as an adjunct to drug therapy for reducing the frequency of seizures in patients with drug-refractory epilepsy with partial-onset seizures. Medtronic says it anticipates approval by this summer (1"The Gray Sheet" Nov. 30, 2009). The firm has marketed its Activa DBS therapy for Parkinson's and essential tremor for more than a decade, and is also pursuing a depression indication