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FDA Expands Indications for Noninvasive Vagus Nerve Stimulator

January 31, 2018

The Food and Drug Administration (FDA) has expanded indications for the gammaCore (electroCore LLC) noninvasive vagus nerve stimulator to include the acute treatment of pain associated with migraine headaches in adults. The new 510(k) clearance is based on results of the unpublished PRESTO randomized sham-controlled trial (NCT02686034).

The FDA originally cleared gammaCore in April 2017 for the acute treatment of pain associated with episodic cluster headache in adults. That clearance was granted through the agency’s de novo review pathway. The new 510(k) clearance for gammaCore to treat migraine headache attacks was granted on January 23, 2018.

gammaCore is a hand-held prescription device that is placed externally on the side of the neck in the vicinity of the vagus nerve to deliver a low voltage electric signal to the nerve’s afferent fibers. U.S. commercial availability of the device for migraine headache is slated for the second quarter of 2018.

An updated Hayes Technology Prognosis Overview on gammaCore is in progress.

 

gammaCore Receives FDA Clearance for the Acute Treatment of Pain Associated with Migraine Headache in Adult Patients. January 29, 2018. PR Newswire [website]. Available at: click here. Accessed January 30, 2018.