electroCore launches new vagus nerve stimulator in US
Neuroscience and technology firm electroCore has commercially launched its non-invasive vagus nerve stimulator gammaCore in the US, to acutely treat pain associated with episodic cluster headache in adults.
The hand-held medical device can be applied to the neck to send mild electrical stimulation through the skin for stimulation of afferent fibres of the vagus nerve that in turn causes mitigation of the pain.
gammaCore is a portable, easy-to-use technology, which can be self-administered without potential side effects that are usually observed during standard of care.
electroCore CEO Francis Amato said: “It provides episodic cluster headache sufferers with a much-needed treatment option for this rare and often debilitating condition.
“The commercial launch also signifies an important milestone for electroCore, marking the first marketed product for the company in the US.”
The US Food and Drug Administration (FDA) released the vagus nerve stimulator in April and granted 510(k) clearance for commercialisation in the country in June.
gammaCore is accessible to the patients who are enrolled in a non-research registry called gammaCore Patient Registry (GPR) established at select headache centres in the country to assess patient experience with the device.
The registered patients will be eligible to receive gammaCore treatment over a period of two months at free of cost and are required to share their experience, as well as information on periodic quality-of-life and self-reported outcomes.
GPR additionally offers an online tracker to record cluster attacks, training from a GPR coordinator on gammaCore use, and access to support from a care specialist during the treatment period.
Image: gammaCore. Photo: courtesy of PRNewsfoto/electroCore LLC.