FDA Approves Second Brain Implant to Reduce Symptoms of Parkinson’s disease

The Food and Drug Administration (FDA) on Friday approved a second brain implant to reduce the symptoms of Parkinson's disease and essential tremor, a neurological disorder that causes rhythmic shaking.

The device, Brio Neurostimulation System, is an implantable small generator that delivers low intensity electrical pulses to target areas in the brain.

It has been said that the FDA in 1997 approved Medtronic PLC's Activa Deep Brain Stimulation Therapy System for tremors associated with essential tremor and Parkinson's disease. It further expanded it in 2002 in order to include other symptoms of Parkinson's disease.

Parkinson's is a neurological disorder that affects about one million Americans. As per estimates around 50,000 Americans are diagnosed with Parkinson's each year, according to the National Institutes of Health.

So far there has been no cure for Parkinson's or essential tremor. Parkinson's is majorly diagnosed in people over 60 years old, while essential tremor usually occurs in those over 40.

The FDA explaining the process said that during the implant a battery-powered, rechargeable electrical pulse generator is implanted under the skin of the upper chest and wire leads that are attached to electrodes placed within the brain.

The agency warned that the procedure also includes some serious adverse events includes intracranial bleeding, which can lead to stroke, paralysis or death. Other adverse events included infection and dislocation of the device lead under the skin.

The FDA said Brio Neurostimulation System can be used at a time when medication alone may not provide adequate relief from symptoms such as walking difficulties, balance problems, and tremors associated with the two movement disorders.