USA – First Device Cleared for the Prevention of Cluster Headache

FDA cleared electroCore's vagus nerve stimulator for the preventive treatment of cluster headache in adult patients.

Cluster headache is considered one of the most painful conditions known to mankind. While there are drugs and devices designed to treat these sudden and excruciating headaches, there are currently no FDA-approved pharmacologic treatments for the prevention of cluster headache. There is, however a device that just received FDA clearance to do just that.

Basking Ridge, NJ-based electroCore previously had 510(k) clearance to offer its gammaCore vagus nerve stimulator as a treatment option, but FDA just cleared an expanded label for the device. The new label makes it the first product FDA cleared for the prevention of the condition.

“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,” said electroCore CEO Frank Amato. “We are pleased that cluster headache patients now have an 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.”…