Noninvasive vagus nerve stimulation (nVNS) device receives FDA expansion to treat adolescent migraine
FDA clearance expands label to include the acute and preventive treatment of migraine in adolescents 12 to 17 years of age
On February 16, electroCore, Inc. announced that the United States Food and Drug Administration (FDA) had granted the company 510(k) clearance to expand the label of gammaCore™ nVNS to include the acute and preventive treatment of migraine in adolescents between 12 and 17 years of age. The device is now cleared for most forms of primary headache, including the acute and preventive treatment of migraine in adolescents and adults, as well as the acute and preventive treatment of cluster headache in adults, according to the statement.
The expansion adds to the company’s original clearance from the FDA for the hand-held device, which was granted in 2017 for acute treatment of pain associated with episodic cluster headache. Used as an adjunctive therapy, the device is used to apply mild electrical stimulation to the vagus nerve, which passes through the skin. Read more about the technology here.
According to the company’s press release, the label expansion was based on previously reported randomized controlled trials of the hand-held nVNS device for the acute and preventive treatment of migraine, and was supported by a small study (n=9) in adolescents where 46.8% of all treated attacks were successfully resolved without the use of any acute rescue medication.
This article is notice of a new approval, not intended to be an endorsement of a particular product and/or treatment modality.