The Food and Drug Administration (FDA) has granted 510(k) clearance to expand the approval of gammaCore® (electroCore) to include the acute and preventive treatment of migraine in adolescents between 12 and 17 years of age. Previously, gammaCore was only approved for this indication in adults.
The portable, hand-held device produces a low voltage electric signal that generates an electric field in the vicinity of the vagus nerve when placed on the neck. The expanded approval was based on previously reported randomized controlled trials of gammaCore in adults, as well as results from a small study (n=9) in adolescent patients. Findings from the adolescent study showed that 46.8% (22/47) of treated attacks were successfully resolved without the use of any acute rescue medication.
Patients should not use gammaCore if they have an active implantable medical device (eg, pacemaker, hearing aid implant), metallic device such as a stent, bone plate, or bone screw implanted at or near their neck, or if they are using another device at the same time (eg, TENS Unit, muscle stimulator or any portable electronic device such as a mobile phone).
The device is available through prescription only. Additional information on the prescribing process can be found here.
electroCore announces 510(k) clearance of gammaCore™ non-invasive vagus nerve stimulation (nVNS) to treat adolescent migraine. [press release]. Rockaway, NJ: electroCore, Inc; February 16, 2021.