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.