Salvia BioElectronics
The purpose of this pivotal clinical study is to evaluate the safety and effectiveness of the MySalvia System, a minimally invasive implantable neuromodulation therapy, for the preventive treatment of adults with resistant migraine.
Inclusion Criteria: Meets resistant migraine criteria: 1. Documented diagnosis of 1.1 migraine without aura and/or 1.2 migraine with aura and/or 1.3 chronic migraine according to ICHD-3 2. Headache requiring two of the following: * Leads to considerable impairment in personal, educational and/or occupational areas of functioning (MIDAS rating of severe or very severe) * Concomitant continuous or near continuous headache between migraine attacks * Eight or more monthly migraine days 3. Lack of 50% reduction in monthly migraine days and/or intolerable side effects and/or absolute con…
A neurostimulation system that consists of implantable and non-implantable components that work together to deliver mild electrical signals to targeted craniofacial nerves.
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