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64000-00120 Rev 3
Warnings
• The safety and effectiveness of gammaCore (nVNS) have 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 migraine
headache, chronic cluster headache, or episodic cluster headache.
• The long-term effects of the chronic use of the device have not been evaluated.
• Safety and efficacy of gammaCore have not been evaluated in the following patients, and
therefore it is NOT indicated for:
o Patients with an active implantable medical device, such as a pacemaker, hearing aid implant,
or any implanted electronic device
o Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
o Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
o Pediatric patients
o Pregnant women
o Patients with active cancer or cancer in remission
o Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia
o Patients with an abnormal cervical anatomy
o Patients with a history of brain tumor
o Patients with aneurysms
o Patients with “bleed or head trauma”
o Patients with a history of baseline cardiac disease or atherosclerotic cardiovascular disease,
including congestive heart failure (CHF), known severe coronary artery disease or recent
myocardial infarction (within 5 years).
o Patients with a history of a prolonged QT interval or arrhythmia
o Patients with a history of an abnormal baseline ECG (e.g. second and third degree heart
block, atrial fibrillation, atrial flutter, recent history of ventricular tachycardia or ventricular
fibrillation, or clinically significant premature ventricular contraction)
o Patients with uncontrolled hypertension
o Patients with a history of seizures
• Do not use gammaCore:
o
While driving, operating machinery, or during any activity that may put you at risk of injury.
o If you have a metallic device such as a stent, bone plate, or bone screw implanted at or near
your neck. You must inform your HCP of any planned surgeries that may involve implants.
o Near Microwave rays, MR, X-Ray, RF surgical, or CAT machines. gammaCore is not
compatible for use in an MR field.
o In an explosive atmosphere or in the presence of flammable gas mixtures.
o If you have an open wound, rash, infection, swelling, cut, sore, drug patch, or surgical scar(s)
on your neck at the treatment location.
o If you have wet skin, are in the water, or just stepped out of the water (e.g., shower, bath, pool).
o If you are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any
portable electronic device (e.g., mobile phone).
