Brio Neurostimulation System is the second device over 18 years to be approved by the U.S. Food and Drug Administration to help in reducing Parkinson and essential tremor symptoms.
The Brio Neurostimulation System is a small device that stimulates areas connected to the most common symptoms of both Parkinson’s disease and essential tremor.
The small device is designed to aid with reducing walking difficulties, tremors or balance problems in addition to medication that over the years becomes less and less effective.
In the U.S. there are an estimated 50,000 people yearly who are diagnosed with Parkinson’s disease. Data coming for the National Institutes of Health indicate that currently, one million U.S. citizens are suffering from the neurological disease.
Parkinson’s is generally characterized by an impairment of brain cells that are responsible for producing dopamine, or their death observed in people in the age groups above 60.
In contrast with Parkinson’s, essential tremors are affecting more millions and are observed in age groups of 40 and above.
The new Brio Neurostimulation System aims at improving these conditions by restoring abilities to function to a near normal level.
William Maisel, M.D. and M.P.H. from the Office of Device Evaluations at the Food and Drug Administration stated:
“There are no cures for Parkinson’s disease or essential tremor, but finding better ways to manage symptoms is essential for patients. This new device adds to the array of treatment options to help people living with Parkinson’s and essential tremor enjoy better, more productive lives.”
The neurostimulating device measures 1.9×2.1×0.4 inches and is powered by a rechargeable battery. It acts as an electrical pulse generator which, once implanted beneath the skin in the upper chest area connects the wires to the electrodes planted in the brain.
Brio Neurostimulation System generates low intensity pulses targeting the specific area where the electrodes are implanted. Clinicians are always able to adjust the intensity and pace of the electrical pulses for optimal effects.
Before the FDA approval the Brio Neurostimulation System underwent two clinical trials, one comprising a total of 136 Parkinson’s patients. The second trial comprised 127 patients suffering from essential tremors. Both groups were not responding well to conventional drug therapies designed for the two neurological conditions.
For the first group, the effects of the device were assessed after a period of three months, while for the second group the assessment took place after six months from the implant. Generally, patients controlled the symptoms of their neurological conditions without the need for drug therapy.
The neurological control device is currently manufactured by St. Jude Medical from St. Paul, Minnesota.
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