Parkinson's Brain Stimulation Device Gains FDA Approval
FDA approves neurostimulation device for Parkinson's and essential tremor
The FDA has approved the Brio Neurostimulation System that aids in the reduction of symptoms of Parkinson's disease and essential tremor.
The battery-powered, rechargeable device is implanted under the skin of the upper chest where wire leads attach to electrodes placed in the brain based on what symptoms the device is treating. The device continuously delivers low-intensity electrical pulses and can be manipulated by health care providers in order to optimize the effects of the device for specific patients and needs.
“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, MD, MPH, acting director of the Office of Device Evaluation at the FDA's Center for Devices and Radiological Health. “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, which is the second to be approved by the FDA for Parkinson's and essential tremor, was evaluated for safety and efficacy in two clinical trials, one with 136 Parkinson's patients and the other with 127 patients with essential tremor. Both groups of patients had symptoms that were not well-controlled by medication.
The Brio system, which is manufactured by St. Jude Medical, was used in addition to medication in patients with Parkinson's disease, while the majority of patients with essential tremor were able to control their symptoms with the device alone. Both groups showed statistically significant improvement on their primary effectiveness endpoint while the device was turned on compared to off.
Adverse events included infections and dislocation of the device lead under the skin, as well as intracranial bleeding, which can be serious and lead to stroke, paralysis, or death.
Food and Drug Administration. FDA approves brain implant to help reduce Parkinson's disease and essential tremor symptoms. FDA News Release. June 12, 2015.