ElectroCore wins cluster headache FDA 510(k) indication for GammaCore

ElectroCore said today that it won expanded FDA 510(k) clearance for its GammaCore non-invasive vagus nerve stimulation therapy, now cleared for adjunctive use for the preventive treatment of cluster headaches in adult patients. The Basking Ridge, N.J.-based company’s GammaCore device is a non-invasive, hand-held vagus nerve stimulation device designed for the reduction of pain. The system is intended to be applied to the neck and applies a patented electrical stimulation through the skin to activate the vagus nerve. The expanded approval was supported by results from two studies which demonstrated the safety and efficacy of the system in preventing the treatment of cluster headaches, ElectroCore said, including data from its pivotal Preva study and a real-world retrospective study. Results from the Preva study indicated that patients who received the standard of care and treatment and treatment with the GammaCore had a greater reduction in the number of cluster attacks per week from baseline than those who only received the standard of care. Patients treated with the GammaCore device experienced a total of 3.9 fewer attacks per week, ElectroCore said. Data also indicated that 40% of patients who received GammaCore treatment alongside the standard of care had a 50% or greater reduction in weekly cluster attacks, versus only 8.3% of patients who received the standard of care, ElectroCore said. Investigators also noted a 57% decrease in the frequency of abortive medication f...
Source: Mass Device - Category: Medical Devices Authors: Tags: 510(k) Featured Food & Drug Administration (FDA) Neurological Regulatory/Compliance electroCore Source Type: news