Parkinson’s brain stimulation device approved by FDA
The Brio Neurostimulation System has been approved by U.S Food and Drug Administration.
The Brio Neurostimulation System is a device that can be planted in the brain to battle Parkinson’s disease and was FDA approved on June 12th.
The Brio Neurostimulation System 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 agency estimates that about 50,000 Americans are diagnosed with Parkinson's annually, while essential tremor affects about several million people, most over the age of 40.
Dr. William Maisel, acting director of the Office of Device Evaluation at the FDA's Centre for Devices and Radiological Health, said: "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 device consists of a small, rechargeable, battery-powered pulse generator implanted under the skin. Wire leads from the generator lead to, illness specific, brain locations and people trained in using the devices can adjust the pulse generator's effects as needed.
The Brio Neurostimulation System was approved based on the results of 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 already failed to control patients' symptoms. However, both groups showed statistically significant improvement on their primary effectiveness endpoint when the device was turned on, compared to when it was turned off.
Brio Neurostimulation System is the second device approved by the FDA for Parkinson’s and essential tremor.