ShiraTronics completes enrollment in pivotal trial of an implanted migraine stimulator
RELIEV-CM2 enrolled 300 people with chronic migraine across 28 sites; five new billing codes take effect in 2027.
ShiraTronics has finished enrolling its pivotal RELIEV-CM2 study of a fully implantable neurostimulator for chronic migraine. It enrolled 300 participants at 28 US and Australian sites, and 146 have received implants. The device stimulates nerves of the trigeminal complex from outside the skull. The American Medical Association has accepted five new billing codes for the procedure, effective January 2027. The company plans to seek FDA premarket approval after the results.
Chronic migraine affects millions of people who get little relief from drugs, making it a large potential market for implanted neuromodulation.
Learn more: Neurotechnology · ShiraTronics