In 2018, Congress mandated that the VA establish the Headache Centers of Excellence (HCOE) to address the growing need for improved care within the VA Healthcare System. The care of migraine has now expanded through the VA using the care guidelines established by the HCOE.
The use of non-medication neuromodulation is included in those care guidelines and is a covered VA benefit.
SAVI Dual is the only non-invasive, patient-administered central neuromodulation device that directly targets and signals the brain to quiet the hyperactive nerves thought to be the source of migraine. This smart technology includes Remote Therapeutic Monitoring that allows you to monitor patient progress.
SAVI Dual is the only FDA cleared central neuromodulation therapy for both acute and preventive treatment in patients 12 years and older.
In a study of people who treated with STMS (SAVI Dual), 46% reported a 50% reduction of migraine days at 12 weeks. In another study, more people using SAVI Dual experienced pain freedom and freedom from bothersome migraine symptoms at 2 hours versus placebo. These benefits were sustained through 48 hours.
The most commonly reported device related adverse events: lightheadedness (3.7%), tingling (3.2%) and tinnitus (3.2%), these typically resolve immediately after treatment. There have been no serious adverse events reported.
SAVI Dual is contraindicated for patients with conductive metal implants in the head and neck, excluding dental work. MRI Protocols may be a reasonable guide in assessing the safety of SAVI Dual in patients with metal in the head and neck.