Brio Neurostimulation System, as it is being called, is “an implantable deep brain stimulation device to help reduce the symptoms of Parkinson’s disease and essential tremor, a movement disorder that is one of the most common causes of tremors,” the FDA said in a news release.
This device is reported to consist of a small, rechargeable battery-powered “pulse generator” which is implanted under the skin. Wire leads from the generator go to specific brain locations depending on the target area of the brain where the illness lies. People trained in using the devices can adjust the pulse generator’s effects as needed, the FDA said.
The FDA approved the device after it was tested under two clinical trials, one involving 136 patients with Parkinson’s disease who used the device for three months, and another involving 127 patients with essential tremor who used it for six months. In both studies, medications had been unable to reduce the patients’ symptoms as the FDA clarified.
“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 the news 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,” he said.
“Brio Neurostimulation System is the second device approved by the FDA for Parkinson’s and essential tremor,” the agency said. “The first device, Medtronic’s Activa Deep Brain Stimulation Therapy System, was approved in 1997 for tremor associated with essential tremor and Parkinson’s disease. In 2002, the indications were expanded to include the symptoms of Parkinson’s disease.”
The device does have it set of risks and drawbacks. Infection, device dislocation are a potential problems a patient might face, and more seriously it can trigger an intracranial bleed, leading to stroke, paralysis or even death.
Essential facts about Parkinson’s disease:
– 50,000 Americans are diagnosed with Parkinson’s annually. To learn more about the symptoms of Parkinson’s disease check out more information and early signs and symptoms on: Parkinson’s disease
– Essential tremor affects “several million” people, most over the age of 40.
– The Center for Disease control rated complications from Parkinson’s disease as the 14th leading cause of death in the United States.
– Worldwide, it is estimated that four to six million people suffer from the condition. There is hope, however, as scientists work towards a cure and make progress in identifying the best treatment options for patients.