MONDAY, June 15, 2015 (HealthDay News) -- The Brio Neurostimulation System has been approved by the U.S. Food and Drug Administration to treat tremors, difficulty walking and other symptoms of Parkinson's disease and essential tremor.
The implanted stimulation device is sanctioned when medication alone doesn't provide adequate relief of symptoms, the FDA said in a news release.
Some 50,000 Americans are diagnosed annually with Parkinson's, and the neurological disorder affects a total of about 1 million Americans, the agency said. Typically diagnosed among people aged 60 and older, it's caused by the death or impairment of brain cells that produce the chemical dopamine.
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A similar condition, essential tremor, affects several million people and is usually diagnosed among people aged 40 and older.
The new product consists of a battery-powered small transmitter implanted in the upper chest that's connected to electrodes strategically placed on the brain. Low intensity electrical pulses help patients better achieve balance and activities such as walking.
The device was evaluated in clinical studies involving more than 250 people whose Parkinson's or essential tremor symptoms weren't adequately controlled by medication. The most serious adverse reaction was potentially fatal bleeding inside the skull. Other adverse reactions included infection and dislocation of an electrode under the skin, the FDA said.
The Brio Neurostimulation System is produced by St. Jude Medical, based in St. Paul, Minn.
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