www.fdanews.com/articles/206215-electrocores-gammacore-vagus-nerve-stimulator-an-fda-breakthrough-device
Electrocore’s gammaCore Vagus Nerve Stimulator an FDA Breakthrough Device
January 19, 2022
The FDA has granted ElectroCore’s gammaCore noninvasive vagus nerve stimulator (nVNS) a Breakthrough Device designation.
The device, which is designed to treat posttraumatic stress disorder (PTSD), reduced symptoms in a clinical trial by 31 percent when compared to placebo, according to the Rockaway, N.J.-based company.
The study data also showed that the stimulation blocks sympathetic nervous system and inflammatory responses to memories of traumatic events in PTSD patients.