FDA Approves Brain Stimulation Device for Patients Battling with Parkinson’s Disease

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The U.S. Food and Drug Administration (FDA) recently approved a brain stimulation device to help patients battling with Parkinson’s disease, which disproportionately affects Latinos, Health Day reports.

The BRIO Neurostimulation system is “an implantable deep brain stimulation device to help reduce the symptoms of Parkinson’s disease and essential tremor, a movement disorder that is one of the most common causes of tremors,” the FDA said in a news release.

The Brio System was approved by the FDA after two clinical trials, one involving 127 patients with essential tremor who used the device for six months, and one involving 136 patients with Parkinson’s disease who used the Brio system for three months.

“Both groups showed statistically significant improvement on their primary effectiveness endpoint when the device was turned on, compared to when it was turned off,” the FDA said.

The FDA reports that the device does come with a few risks such as intracranial bleeding, which can lead to stroke, paralysis or death.”

According to a study reported by Kaiser Permanente “Hispanics had the highest rate (Parkinson’s disease) at 16.6 cases per 100,000, followed by non-Hispanic whites at 13.6 per 100,000.”