ElectroCore's gammaCore (nVNS) Receives FDA's 510(k) Approval- a Novel Therapy for Cluster Headache in Adults
Shots:
- The approval is supported by PREVA (PREVention and Acute treatment of chronic cluster headache) and Real World retrospective study assessing its gammaCore + SoC vs SoC alone evaluating safety & efficacy with its daily clinical use in adults with cluster headache
- Results: reduction in cluster attacks per week (-5.9 vs -2.1); mean therapeutic gain in attacks per week 3.9- weekly reduction 50% vs 8.3%- 57% decrease in frequency of abortive medication; safe and well- tolerated
- gammaCore (nVNS) is a bid self-administered non-invasive novel adjunctive therapy with mild electrical stimulation applied at the vagus nerve (neck portion)- to prevent cluster and migraine headache in adult patients
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