First Device Cleared for the Prevention of Cluster Headache

In this study, gammaCore was found to be safe and well tolerated. The incidence of adverse events was similar between patients using gammaCore plus standard of care compared to standard of care alone. The majority of the adverse events were mild and transient. The most common adverse events reported in 5% of patients or more in the gammaCore group were headache (8%), dizziness (6%), and neck pain (6%). None of the serious adverse events were considered device-related. To prevent cluster headaches, adult patients should self-administer two gammaCore treatments daily. Each treatment consists of three consecutive two-minute stimulations. The first treatment should be applied within one hour of waking up and the second treatment should be applied at least seven to 10 hours later. The device is a hand-held device applied to the neck that delivers a mild electrical stimulation to the vagus nerve that passes through the skin. Designed as a portable, easy-to-use technology, gammaCore can be self-administered by patients, as needed, without the potential side effects associated with commonly prescribed drugs. When placed on a patient’s neck over the vagus nerve, gammaCore stimulates the nerve’s afferent fibers, which may lead to a reduction of pain in patients.
Source: MDDI - Category: Medical Devices Authors: Tags: Business Source Type: news