FDA Clears Hand-Held Vagus Nerve Stimulator for Migraine Prevention

The FDA has approved an expanded indication for the gammaCore device to include prevention of migraine.

The Food and Drug Administration (FDA) has approved an expanded indication for gammaCore® (electroCore) to include the prevention of migraine in adult patients. 

The non-invasive vagus nerve stimulation device is already indicated as an adjunctive therapy for the acute treatment of pain associated with episodic cluster headache and migraine headache and for the preventive treatment of cluster headache. The portable device produces a low voltage electric signal that generates an electric field in the vicinity of the vagus nerve.

The efficacy of gammaCore for the prevention of chronic and episodic migraine was demonstrated in 2 clinical trials (NCT01667250 and NCT02378844). Patients were instructed to use gammaCore 3 times per day, with 2 consecutive bilateral stimulations upon waking, 6 to 8 hours following the first daily treatment and 6 to 8 hours following the second daily treatment.

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The safety and efficacy of gammaCore have not been established in individuals that have an active implantable medical device, in patients diagnosed with carotid atherosclerosis, or in those who have had cervical vagotomy. In addition, treatment is not indicated for pediatric patients, pregnant women, and those with clinically significant hypertension, hypotension, bradycardia, or tachycardia.

Patients should not use gammaCore if they have a 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. Healthcare providers can prescribe gammaCore by completing a patient enrollment form found here.

For more information visit gammacore.com.