FDA approves Brio's brain implant for Parkinson's
- The FDA has approved the Brio Neurostimulation System, which is an implantable deep brain stimulation device intended to help reduce the symptoms of Parkinson's diseae (PD) and essential tremor.
- This is the second FDA-approved device for Parkinson's and essential tremor.
- Approval is based on a clinical database, which includes two clinical trials focused on efficacy and safety. One trial included 136 patients with PD, and the other included 127 patients with essential tremor.
Approximately 50,000 Americans are diagnosed each year with PD, according to the NIH, with a total affected population of roughly one million Americans. While there are many treatments for PD, including levodopa, the standard of care, some symptoms are harder to treat and have fewer treatment options, including PD-related tremor, as well as essential tremor.
The Bio Neurostimulation System is a small, battery-powered rechargeable electrical pulse generator, which is implanted under the skin of the upper chest. It has wire leads that attach to electrodes placed within the brain at specific locations dependng on how the device is intended to be used—either for PD or essential tremors, according to the FDA.
This device has the potential to address the challenge faced by thousands of individuals with PD-related tremors, or essential tremors.