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# FDA Clears gammaCore for Expanded Use for Migraines
- URL: https://www.fdaweb.com/fda-clears-gammacore-for-expanded-use-for-migraines/
- Published: 2018-01-29T12:00:00.000Z
- Updated: 2026-09-14T23:17:49.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5140619

FDA has cleared an electroCore 510(k) for an expanded label for gammaCore as an acute treatment of pain associated with migraine in adult patients. The neuromodulation treatment is delivered by a hand-held unit that stimulates the vagus nerve through the skin. It was initially cleared 4/2017 for acute treatment of pain associated with episodic cluster headache in adult patients.

The expanded clearance was based on data from a multicenter, randomized, double-blind, sham-controlled trial called PRESTO. The trial demonstrated that treatment with gammaCore for the acute treatment of pain associated with migraine was superior to sham, and also enabled patients to reach pain freedom more frequently by 30, 60, and 120 minutes compared with the sham treatment, according to the company.