StimRelieve has received investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to begin clinical trial of the percutaneously implantable device for the treatment of chronic migraines.
The approval has been granted for StimRelieve Halo migraine system for the treatment of chronic migraine refractory to more conservative therapies such as NSAIDs, migraine-specific drugs, or combination drug therapy.
The study will evaluate the safety and effectiveness of occipital and supraorbital nerve stimulation using Halo migraine system for the treatment of chronic migraines.
A discreetly-worn external transmitter worn on the ear offers energy and therapy to the implanted device.
According to the company, the study’s aim is to achieve a 30% reduction in headaches with no increase in medication at three months as compared to the control group that will have no active treatment during the same period.
StimRelieve chairman and president Laura Tyler Perryman said: "We are delighted to be moving forward with this study to demonstrate the potential of our product platform to address a wide variety of chronic issues with minimally-invasive neuromodulation treatments.
"If this study demonstrates safety and effectiveness, StimRelieve can help millions of people in the US who are suffering from chronic migraines, without the need for extensive surgery or bulky implants in their chest."
StimRelieve products are not yet received approval for sale or commercial distribution, and will be available for investigational use only.