gammaCore™ sends gentle stimulation through the skin to activate the vagus nerve. The vagus nerve, which plays an important role in regulating pain, is a highway of communication between your brain and many parts of your body. This gentle stimulation provides relief from migraine and episodic cluster headache pain.
Effective and long-lasting migraine relief
- Some adults felt relief as quickly as 30 minutes
- Almost half of adults had little to migraine pain within 2 hours after first use
- The majority of migraine patients who were pain-free at 2 hours remained pain-free for 48 hours
Fast, reliable relief for episodic cluster headache
- Many patients felt significant relief as quickly as 15 minutes
- Many patients felt relief in the majority of treated attacks
- Many patients experience a decrease in the length and severity of their attacks
US Indication and ISI
gammaCore™ (non-invasive vagus nerve stimulator) is indicated for the acute treatment of pain associated with episodic cluster headache and migraine headache in adult patients
- The safety and effectiveness of gammaCore™ (nVNS) have not been established in the acute treatment of chronic cluster headache
- gammaCore™ has not been shown to be effective for the prophylactic treatment of migraine headache, chronic cluster headache, or episodic cluster
- The long-term effects of the chronic use of gammaCore™ have not been evaluated
- Safety and efficacy of gammaCore™ have not been evaluated in the following patients, and therefore it 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 (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., 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.
Available by prescription only. Federal law restricts this device to sale by or on the order of a licensed healthcare provider.
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