FDA granted investigational device exemption approval for privately held StimRelieve LLC to launch a study of what the firm says is the world’s smallest percutaneously implantable device for the treatment of refractory craniofacial neuropathic pain. The Florida-based firm will assess the StimRelieve Halo CFNS system, which involves wirelessly powered, miniature neurostimulators leveraging nanotechnology to treat refractory craniofacial pain ailments, such as temporomandibular joint disorders, persistent idiopathic facial pain (atypical facial pain) conditions, and a variety of other cranial or facial pain syndromes.
The system includes an external transmitter placed on the ear providing energy and therapy to the implanted device. The goal of the study is to achieve sustained pain reduction of...
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