The Brio Neurostimulation System, an implantable deep brain stimulation device to help reduce the symptoms of Parkinson disease and essential tremor, was granted FDA approval.
The system is a small battery-powered, rechargeable electrical pulse generator implanted under the skin of the upper chest and wire leads that attach to electrodes placed at specific locations within the brain. The electrical pulse generator continuously delivers low intensity electrical pulses to targeted areas.
The FDA approval is based on 2 clinical studies on the safety and efficacy of the device in 136 patients with Parkinson disease and 127 patients with essential tremor.
Citation: FDA approves brain implant to help reduce Parkinson’s disease and essential tremor symptoms. FDA website. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm451152.htm. Updated June 12, 2015. Accessed June 23, 2015.
This Week's Must Reads
Risk Factors for Suicidality in Huntington Disease, Neurology; ePub 2019 Mar 8; McGarry, et al
Socioeconomic Disparities in US Stroke Survivors, Stroke; ePub 2019 Mar 11; Elfassy, Grasset, et al
Treating Stroke Patients with tPA via Telemedicine, Stroke; ePub 2019 Mar 11; Wysocki, et al
Can a Modified Ketogenic Diet Reduce Seizures?, Epilepsy Behav; ePub 2019 Mar 10; Roehl, et al
No Association Between Self-Reported TBI and AD, Alzheimers Dement; ePub 2019 Mar 6; Sugarman, et al
Must Reads in Health Policy
Later School Start Times, Sleep Health Evaluated , Sleep; ePub 2018 Nov 3; Nahmod, Lee, et al
FDA Approves Briviact for Partial-Onset Seizures, UCB website; 2016 Feb 19; news release
FDA Approves Perampanel for Tonic-Clonic Seizures, Epilepsy drug previously approved for partial-onset seizures
Device Approval: Brio Neurostimulation System , Implantable DBS device for essential tremor and Parkinson disease