FDA Grants 510(k) Clearance to electroCore’s Vagus Nerve Stimulator
ElectroCore has received the FDA’s 510(k) clearance for an expanded label for its gammaCore noninvasive vagus nerve stimulation (nVNS) device for prevention and treatment of cluster headaches.
The expanded label includes treatment of two rare forms of trigeminal autonomic cephalalgias, a group of headache disorders characterized by unilateral distribution of pain in the nerve that carries sensation from the face to the brain. The two conditions, paroxysmal hemicrania and hemicrania continua, are typically debilitating and difficult to treat.
The noninvasive gammaCore device works by delivering a mild electrical stimulation to the vagus nerve without the need for surgery, avoiding the side effects of injectable, inhaled or pill-based medicines.