Important Safety Information

gammaCoreTM (non-invasive vagus nerve stimulator) is intended to provide non-invasive vagus nerve stimulation (nVNS) on the side of the neck. gammaCore is indicated for:

  • The preventive treatment of migraine headache in adolescent (age 12 and older) and adult patients.
  • The acute treatment of pain associated with migraine headache in adolescent (age 12 and older) and adult patients.
  • Adjunctive use for the preventive treatment of cluster headache in adult patients.
  • The acute treatment of pain associated with episodic cluster headache in adult patients.
  • The effectiveness of gammaCore has not been established in the acute treatment of chronic cluster headache
  • gammaCore is contraindicated for patients with:
    • An active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
    • A metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck
    • An open wound, rash, infection, swelling, cut, sore, drug patch, or surgical scar(s) on the neck at the treatment location
  • Safety and efficacy of gammaCore have not been evaluated in the following patients:
    • 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 (younger than 12 years)
    • Pregnant women
    • Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia