FDA extends 510(K) clearance for electroCore’s gammaCore (nVNS)
electroCore sought 510(k) clearance from the U.S Food and Drug Administration for an extended label for gammaCore (nVNS) as an acute treatment of pain associated with migraine in adult patients. gammaCore therapy is a proprietary, non-invasive neuromodulation treatment delivered by a hand-held unit that stimulates the vagus nerve through the skin. gammaCore is also available outside of the U.S., including in Canada and the European Economic Area. In the U.S., gammaCore is commercially available for the acute treatment of pain associated with episodic cluster headache in adults.
Stephen D. Silberstein, M.D., Professor of Neurology and Director of the Headache Center, Thomas Jefferson University claimed “Migraine is a debilitating disease affecting 39 million Americans, the majority of whom do not seek medical care for their pain.1 With the FDA’s decision to release gammaCore for migraine, patients now have access to an effective and safe therapy which can be self-administered to acutely treat the pain associated with migraine.”
Results of the multicenter, randomized, double-blind, sham-controlled trial, PRESTO (PRospectivE Study of nVNS for the Acute Treatment Of Migraine).Results from this trial, which were recently exhibited at the Congress of the International Headache Society (IHC) in Vancouver in September 2017, demonstrated that treatment with gammaCore for the acute treatment of pain associated with migraine was superior to sham, and also enabled patients to reach pain freedom more frequently by 30, 60, and 120 minutes compared with sham treatment thus paving way for the FDA clearance.
Image Source: electrocore