Electrocore said today it won FDA 510(k) clearance for its GammaCore device, expanding indications to include the acute treatment of pain associated with migraines in adult patients.
The Basking Ridge, N.J.-based company’s GammaCore device is a non-invasive, hand-held vagus nerve stimulation device designed for the reduction of pain. The system is intended to be applied to the neck and applies a patented electrical stimulation through the skin to activate the vagus nerve.
“Migraine is a debilitating disease affecting 39 million Americans, the majority of whom do not seek medical care for their pain. 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,” Dr. Stephen Silberstein of Thomas Jefferson University said in a prepared statement.
The approval came supported by results from the Presto trial of the device, which indicated that treatment with the GammaCore for pain associated with migraine was superior to sham treatments, and allowed patients to reach pain freedom more frequently by 30, 60 and 120 minutes.
“With annual healthcare and lost productivity costs associated with migraine measured in the tens of billions of dollars in the U.S., the availability of gammaCore provides patients with a new treatment option to relieve migraine pain, while also offering the potential to alleviate some of the economic strain that arises from their condition as well,” CEO Francis Amato said in a press release.
Electrocore touted the expansion as the first for the device since it received its initial FDA clearance for the acute treatment of pain associated with episodic cluster headaches in adult patients last April.