LivaNova reports first patient enrolled in RESTORE-LIFE depression study
LivaNova announced the launch and enrollment of the first patient in the post-market study to assess short-, mid- and long-term effectiveness and efficiency of Vagus Nerve Stimulation therapy as adjunctive therapy in real-world patients with difficult to treat depression, dubbed the "RESTORE-LIFE" study. This study will evaluate the use of LivaNova's VNS Therapy System in patients who have treatment-resistant depression and have failed to achieve an adequate response to standard psychiatric management. RESTORE-LIFE will enroll a minimum of 500 patients who will be implanted with VNS Therapy at up to 80 sites, currently under way internationally outside of the United States. Patients will undergo follow-up for a minimum of three years and a maximum of five years to evaluate changes in clinical symptoms in response to VNS Therapy. The study's primary endpoint is response at one year, defined as a reduction in total score on the Montgomery Asberg Depression Rating Scale of at least 50% from the patient's baseline score. Secondary endpoints will be evaluated as well, including factors such as quality of life, patient function, health care utilization and adjunctive antidepressant treatments.