FDA Approves Second Brain Implant for Parkinson’s Symptoms

Industry News

The U.S. FDA has approved the Brio Neurostimulation System, an implantable deep brain stimulation device to reduce the symptoms associated with Parkinson’s disease (PD) and essential tremor.  The Brio Neurostimulation System is manufactured by St. Jude Medical based in St. Paul, MN and it is the second device approved by the FDA for tremor disorders.  PD is a neurological disorder resulting from the loss of dopamine-producing neurons.  The primary symptoms are tremor, rigidity, bradykinesia and postural instability.  As disease progresses, patients may have difficulty walking, talking, balancing or completing other simple tasks.  At present, there is no cure for PD.  According to the FDA press announcement, the Brio Neurostimulation System consists of a small battery-powered, rechargeable electrical pulse generator implanted under the skin of the upper chest and wire leads that attach to electrodes placed within the brain at specific locations depending on whether the device is being used to treat PD or essential tremor. The electrical pulse generator continuously delivers low intensity electrical pulses to target areas in the brain. Doctors make adjustments to the pulse generator to optimize the effects of the Brio Neurostimulation System.  The FDA approval is based on promising results from two clinical studies involving 136 and 127 patients with PD and essential tremor respectively.



  1. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm451152.htm
  2. http://www.wsj.com/articles/fda-approves-second-brain-implant-for-parkinsons-symptoms-1434146710

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