Basking Ridge, New Jersey-based medical device maker Electrocore has received a 510(k) clearance expanding the label of its non-invasive vagus nerve stimulator (VNS) therapy device to include cluster headache prevention. According to a release from the company announcing the news, no other devices or pharmacologic treatments have received this indication from the agency.
Therapy using the gammaCore device is self-administered, and for cluster headache prevention consists of two daily treatments, each of which is comprised of three consecutive two-minute stimulations. To do so, patients apply a conductive gel to the side of their neck, and then hold the gammaCore to the same area while it dispenses a mild electrical stimulation through the skin and to the vagus nerve.
According to Electrocore, the FDA’s decision was based on data collected in two studies. Among these was an open-label, randomized controlled trial, in which patients who received the therapy with standard of care (n = 45) had a greater reduction in the number of cluster headache attacks per week than those receiving standard of care alone (n = 48; P = .02). Patients in the prior group also reported a decrease in abortive medication use (P < .001), while the incidence of adverse events was roughly similar.
gammaCore is available as a prescription treatment, according to Electrocore, and is also cleared by the FDA for acute treatment of episodic cluster headache pain and migraine headaches in adults.
What’s the impact
As the first indicated therapy for cluster headache prevention, the nVNS device offers an option to patients who previously went unserved. Further, the fact that it is a self-administered, tech-driven offering means that those same patients may not need to turn to the more conventional painkillers currently fueling an opioid epidemic.
What’s the trend
While Electrocore’s VNS system primarily looks to cut down headache pains, similar technology has already been tapped for other nervous system conditions. Last year, for instance, London-based medical device manufacturer LivaNova received an approval for its responsive epilepsy treatment system.
On the record
“The FDA clearance of gammaCore for adjunctive use for the preventive treatment of cluster headache has the potential to help the approximately 350,000 Americans impacted by this debilitating condition often referred to as a ‘suicide headache,’” Frank Amato, CEO of electroCore, said in a statement. “We are pleased that cluster headache patients now have a FDA-cleared option, and one that is both safe and effective, especially given the difficulty in treating cluster headache and the limitations of current treatments.”