|Trade Name||BRIO NEUROSTIMULATION SYSTEM|
|Classification Name||stimulator, electrical, implanted, for parkinsonian tremor|
|Applicant||ST. JUDE MEDICAL NEUROMODULATION|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the brio neurostimulation system. This device is indicated for the following conditions: 1) bilateral stimulation of the subthalamic nucleus (stn) as an adjunctive therapy to reduce some of the symptoms of advanced levodopa-responsive parkinson¿s disease that are not adequately controlled by medications; and 2) unilateral or bilateral stimulation of the ventral intermediate nucleus (vim) of the thalamus for the suppression of disabling upper extremity tremor in adult essential tremor patients whose tremor is not adequately controlled by medications and where the tremor constitutes a significant functional disability.