LivaNova PLC announced that the journal Brain Stimulation published two articles detailing the unipolar cohort data from its RECOVER clinical study for VNS Therapy™ System in treatment-resistant unipolar depression (TRD). The study evaluated the safety and efficacy of VNS Therapy and its impact on quality of life and daily function in patients who had failed an average of more than 13 antidepressant treatments.
While the primary endpoint was not met due to a strong response in the sham group, the active treatment arm demonstrated statistically significant and clinically meaningful improvement from its baseline. Secondary endpoints showed antidepressant benefits favoring active VNS Therapy, as measured by clinician, patient, and masked rater assessments.
Specifically, at 12 months, 32.7% of active VNS Therapy patients achieved at least a 50% reduction in MADRS total score, compared to 20.9% in the sham group. The study also showed greater improvements in quality of life and daily function for patients receiving adjunctive VNS Therapy, supporting the therapy's value for TRD patients.
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