GammaCore Sapphire, a new non-invasive hand-held device for migraine and episodic cluster headache treatment, has been made available by electroCore. 

Originally approved in April 2017, gammaCore is a non-invasive vagus nerve stimulator (nVNS) that is indicated for the acute treatment of pain associated with episodic cluster headache and migraine. The new Sapphire version is smaller and has a smoother stimulation surface with intensity buttons positioned on the side to facilitate therapy adjustments. The device also has a larger and brighter display screen.

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The Sapphire has a rechargeable and reloadable fill capacity; it can be activated monthly by inputting a unique, prescription-only authorization code, delivered via a radio-frequency identification card that is mailed to the patient. The device is only available by prescription and is self-administered by patients; each device allows for treatment of multiple headaches per day (up to 24 stimulations/day).

The safety and effectiveness of gammaCore have not been established in the acute treatment of chronic cluster headache. In addition, gammaCore has not been shown to be effective for the prophylactic treatment of chronic or episodic cluster headache or migraine headache.

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