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Device Approval: Brio Neurostimulation System

Implantable DBS device for essential tremor and Parkinson disease

The Brio Neurostimulation System, an implantable deep brain stimulation device to help reduce the symptoms of Parkinson disease and essential tremor, was granted FDA approval.

The system is a small battery-powered, rechargeable electrical pulse generator implanted under the skin of the upper chest and wire leads that attach to electrodes placed at specific locations within the brain. The electrical pulse generator continuously delivers low intensity electrical pulses to targeted areas.

The FDA approval is based on 2 clinical studies on the safety and efficacy of the device in 136 patients with Parkinson disease and 127 patients with essential tremor.

Citation: FDA approves brain implant to help reduce Parkinson’s disease and essential tremor symptoms. FDA website. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm451152.htm. Updated June 12, 2015. Accessed June 23, 2015.

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Device Approval: Brio Neurostimulation System , Implantable DBS device for essential tremor and Parkinson disease