gammaCore® (electroCore), a noninvasive vagus nerve stimulator device intended for the treatment of pain associated with episodic cluster headache in adults, is now available in the United States.
The hand-held device, which was approved by the US Food and Drug Administration in April 2017, transmits mild electrical stimulation to the vagus nerve through the skin. Approval was based on results from 2 placebo-controlled, randomized trials that showed a significant reduction in pain in patients who used the gammaCore device compared with placebo.
Patients can receive gammaCore through the gammaCore Patient Registry program, which will be offered through a select group of headache centers across the United States. Patients must have a diagnosis of episodic cluster headache and obtain a prescription for gammaCore from their health care provider. Those who qualify to participate in the registry may receive 2 months of gammaCore treatment for free in exchange for sharing their experience with the device.
The gammaCore Patient Registry program also includes an online tracker for patients to track cluster headache attacks, training with a coordinator on how to use the device, online and in-person access to support with a care specialist during treatment, and assistance with co-payments for up to 1 year.
The device is contraindicated for use in patients with an active implantable medical device; those with carotid atherosclerosis; those who have undergone cervical vagotomy; as well as pediatric patients, pregnant women, and those with clinically significant hypertension, hypotension, bradycardia, or tachycardia. Patients should not use gammaCore if they have a metallic device, including a stent, bone plate, or bone screw in or near their neck or while using another electronic device, including a mobile phone, at the same time.
Health care providers who are interested in prescribing gammaCore can visit the device’s website for more information.
gammaCore, the first non-invasive vagus nerve stimulator applied at the neck, now available for adult patients in the US [news release]. ElectroCore newsroom; July 18, 2017.