Important Safety Information

Indication and Important Safety Information

gammaCore (non-invasive vagus nerve stimulator) is indicated for the acute treatment of pain associated with episodic cluster headache in adult patients.

  • The safety and effectiveness of gammaCore has not been established in the acute treatment of chronic Cluster Headache.
  • This device has not been shown to be effective for the prophylactic treatment of chronic or episodic cluster headache.
  • The long-term effects of the chronic use of the device have not been evaluated.
  • Safety and efficacy of gammaCore has not been evaluated in the following patients, and therefore is NOT indicated for:
    • Patients with an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
    • Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
    • Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
    • Pediatric patients
    • Pregnant women
    • Patients 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
    • Are using another device at the same time (eg, TENS Unit, muscle stimulator) or any portable electronic device (eg, mobile phone)

Note: This list is not all inclusive. Please refer to the gammaCore Instructions for Use for all of the important warnings and precautions before using or prescribing this product.