The U.S. Food and Drug Administration (FDA), on Friday, announced the approval of a brain stimulation device for patients with Parkinson's disease and essential tremor.
The Brio Neurostimulation System, developed by St. Jude Medical, is the second brain implant device approved by the FDA (the first was Medtronic's Activa Deep Brain Stimulation Therapy System in 1997), and is designed to help patients with neurological conditions who still experience symptoms despite being on medications.
The device is to be implanted under the skin of the upper chest, with wires attached to electrodes within the brain of the patient. The battery-powered implant will continuously send electrical pulses to the brain for constant stimulation.
"There are no cures for Parkinson's disease or essential tremor, but finding better ways to manage symptoms is essential for patients," said William Maisel, acting director of the Office of Device Evaluation at the FDA's Center for Devices and Radiological Health, in the official press release. "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."
Researchers tested the efficiency of the device in 136 patients with Parkinson's disease and 12 patients with essential tremor. The participants were taking medications yet continued to experience symptoms. For the study, they used the device, along with their medications, for three months. After the follow-up period, both groups showed significant improvement of their conditions.
One of the side effects of the Brio Neurostimulation System is intracranial bleeding, which can lead to stroke, paralysis or death. Some users reported skin infections and dislocation of the device under their skin.
The National Institutes of Health estimates that about one million Americans have Parkinson's disease, but only 50,000 are diagnosed. Parkinson's initially affects one side of the body and causes problems on movement, stiffness and tremors. Essential tremor, on the other hand, affects the hands and arms.
