A Real-World Evidence Study on U.S. Patients Demonstrating Safety of High-Frequency Use of the Remote Electrical Neuromodulation (REN) Wearable Device for Migraine Treatment - Summary - MDSpire
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A Real-World Evidence Study on U.S. Patients Demonstrating Safety of High-Frequency Use of the Remote Electrical Neuromodulation (REN) Wearable Device for Migraine Treatment
This real-world observational study evaluates the safety and tolerability of remote electrical neuromodulation (REN; Nerivio®) in patients who have utilized it more frequently than the current label indication for migraine treatment.
To evaluate the safety and tolerability of REN use that exceeded current labeling for migraine treatment.
Approach:
Study design: Real-world observational study of 1,863 patients with migraine, examining REN use beyond current labeling, including multiple treatments in a single day and daily use.
Key Findings:
The analysis included more than 80,000 treatment sessions.
Device-related adverse events were reported in fewer than 1% of patients; events were negligible to moderate in severity and resolved without medical intervention.
No serious device-related adverse events were reported.
Most patients continued therapy after reporting an adverse event.
Interpretation:
In this real-world study, high-frequency REN use was associated with rare device-related adverse events, with no serious events reported.
Limitations:
The provided context does not describe additional study limitations.
Conclusion:
Across more than 80,000 treatment sessions, device-related adverse events were reported in fewer than 1% of patients; no serious device-related adverse events were reported.
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