Chuck Bednar for redOrbit.com – @BednarChuck
The US Food and Drug Administration has approved a brain implant designed to reduce the symptoms of patients with Parkinson’s disease and essential tremor, a neurological condition which causes a rhythmic shaking, the agency announced on Friday.
The device is known as the Brio Neurostimulation System, and according to Reuters, the unit is a small generator that delivers low intensity electrical pulses to specific parts of the brain. It can be used when medication alone is unable to provide sufficient relief of symptoms such as walking difficulties, balance issues, and tremors associated with both conditions.
The Brio Neurostimulation System is produced by St. Jude Medical Inc. in St. Paul, Minnesota, and is the second implant approved for treatment of Parkinson’s, a disease that affects about 50,000 people in the US each year. The other treatment, the Medtronic PLC’s Activa Deep Brain Stimulation Therapy System, was approved by the FDA back in 1997.
Implant use led to “statistically significant improvement”
According to the Wall Street Journal, this new device is a battery-powered, rechargeable pulse generator that is implanted under the skin of the upper chest, and it contains wire leads that are attached to electrodes placed within the brain. Adverse side effects reported by the FDA include intracranial bleeding, which could lead to stroke, paralysis, or death.
“There are no cures for Parkinson’s disease or essential tremor, but finding better ways to manage symptoms is essential for patients,” Dr. William Maisel, acting director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health, said in a statement. “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 safety and effectiveness of the device was established using a pair of clinical studies, the agency said. The first featured 136 patients with Parkinson’s disease, while the other included 127 patients with essential tremor. In both trials, the FDA said, patients had tremors and other symptoms that were not being adequately controlled through drug therapy alone.
The system was used along with medications in Parkinson’s patients, while the majority of the essential tremor patients using the device able to control their symptoms without the need for any drug treatments, the FDA added. Both groups showed “statistically significant improvement” in symptoms when using the device during the either three-to-six month long trials.
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