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StimRelieve gets FDA IDE approval to start Halo CFNS system trial

StimRelieve has obtained investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to start a clinical trial of the Halo craniofacial nerve stimulator (CFNS) to treat refractory craniofacial neuropathic pain.

The study will evaluate the safety and effectiveness of craniofacial nerve stimulation using the StimRelieve Halo CFNS system to treat refractory neuropathic craniofacial pain.

The Halo CFNS system is based on wireless neuromodulation technology, which includes a minimally-invasive procedure of an implantable stimulator with an embedded receiver through a standard gauge needle, without the need for extensive surgery.

According to the company, the aim of the study is to achieve sustained pain reduction of more than 50% as measured by VAS at three months with no increase in medication compared against control group that will have no active treatment during the same period.

The system, which includes implantable neurostimulator with four or eight electrodes, holds capability to offer stimulation parameter frequencies to 10,000Hz.

StimRelieve chairman and president Laura Tyler Perryman said: "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.

"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."

The firm’s products have not yet received approval for sale or commercial distribution, and are limited to investigational use only.