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Parkinson's Disease

FDA okays brain implant for Parkinson’s patients

Parkinson’s patients in The US can now use the Brio Neurostimulation System, a device that alleviates their symptoms. The U.S. Food and Drug Administration (FDA) approved the implant developed by St. Jude Medical in St. Paul, Minnesota. The device is for patients whose tremors and other Parkinsonian symptoms cannot be mitigated by medication alone. The Brio Neurostimulation System has electrodes, wires and a battery-powered electrical pulse generator. The device is positioned under the skin of the upper chest.

Depending on the symptoms being treated the wires attached to the device are connected to electrodes in different parts of the brain. The generator constantly sends out electrical pulses, which a doctor may adjust to fully suit a patient’s individual needs.

The safety and efficacy of the system were established over two clinical trials conducted through many months on two groups of patients, one of 154 with Parkinsonian symptoms and another of 127 with essential tremors. Neither group was responding well to medication.

At the end of the trials the researchers found that most of the patients with essential tremors and those who had Parkinson’s disease showed improvements. There was a noticeable improvement in their symptoms even without the help of medication. When the device was turned on, the patients felt the improvements in their clinical conditions.

“In the absence of any cure for Parkinson’s disease or essential tremor, it is important to find better ways to manage symptoms,” said William Maisel, acting director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health. “The new device adds to the arsenal of tools developed to help people living with Parkinson’s have a better, more productive life.”

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