electroCore Announces 510(k) Clearance of gammaCore™ Label Expansion into Migraine Prevention
“We are grateful to the FDA for clearing the expanded use of our novel gammaCore vagus nerve stimulation device into the prevention of migraine headache in adults who frequently suffer from this incapacitating condition,” stated
In addition to migraine prevention, gammaCore is currently indicated for adjunctive use for the preventive treatment of cluster headache and for the acute treatment of pain associated with episodic cluster headache and migraine headache in adult patients.
Migraine is an inherited neurological disorder that is characterized by over excitability of specific areas of the brain. Although it is not well understood how a migraine brain is different or what happens in the brain to start a migraine, it is widely accepted that individuals with migraine are more susceptible to the influence of transient factors, termed “triggers,” that raise the risk for having a migraine attack. These triggers include hormonal fluctuations, environmental stimuli like weather or bright lights, certain smells, alcohol, certain foods, poor sleep and high stress. However, not everyone has a clear trigger for migraine attacks.
gammaCore® (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck as an adjunctive therapy to treat migraine and cluster headache through the utilization of a mild electrical stimulation to the vagus nerve that passes through the skin. Designed as a portable, easy-to-use technology, gammaCore can be self-administered by patients, as needed, without the potential side effects associated with commonly prescribed drugs. When placed on a patient’s neck over the vagus nerve, gammaCore stimulates the nerve’s afferent fibers, which may lead to a reduction of pain in patients.
gammaCore is CE-marked in the
- Safety and efficacy of gammaCore have not been evaluated in the following patients:
- 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)
In the US, the FDA has not cleared gammaCore for the acute treatment of chronic cluster headache.
Please refer to the gammaCore Instructions for Use for all of the important warnings and precautions before using or prescribing this product.
This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about electroCore's business prospects and product development plans, its pipeline or potential markets for its technologies, and other statements that are not historical in nature, particularly those that utilize terminology such as "anticipates," "will," "expects," "believes," "intends," other words of similar meaning, derivations of such words and the use of future dates. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to raise the additional funding needed to continue to pursue electroCore’s business and product development plans, the inherent uncertainties associated with developing new products or technologies, the ability to commercialize gammaCore™, competition in the industry in which electroCore operates and overall market conditions. Any forward-looking statements are made as of the date of this press release, and electroCore assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents electroCore files with the SEC available at www.sec.gov.