StimRelieve, a Fort Lauderdale, Florida firm, received an Investigational Device Exemption (IDE) from the FDA to trial its Halo CFNS device designed to treat refractory craniofacial neuropathic pain. The StimRelieve Halo CFNS is a percutaneously implanted neuromodulator that is delivered via a standard gauge needle. The stimulator has a wireless embedded receiver so that the actual energy source stays outside the body, attached nearby to the ear. The actual implant is quite tiny, but capable of delivering stimulation up to 10,000 Hz.
The IDE study will test the system for both safety and efficacy, comparing a control group that will receive no stimulation to those undergoing actual therapy. The goal will be to sustain a 50% reduction in pain in the therapy group, without an increase in the use of medication.
“Our goal is to evolve our core product platform and services to become the default solution for neuromodulation treatments, increasing the accessibility for patients worldwide while reducing the economic impact of treatment,” said Laura Tyler Perryman, StimRelieve Chairman and President, in a statement. “Should the study show positive results for safety and effectiveness, StimRelieve hopes to be able to treat an underserved patient population with a solution that is simple and not intimidating. We look forward to success from the study on the path to bringing this technology to market to provide a practical solution for undertreated patients suffering from craniofacial pain throughout the world.”