The VNS system comprises a programmable electronic pulse generator connected to a bipolar electrical lead that sends mild pulses to trigger the vagus nerve at regular intervals throughout the day.
The global prospective, multi-centre, observational, post-market study will evaluate the short, mid and long-term effectiveness and efficiency of VNS therapy as an adjunctive treatment in real-world patients.
LivaNova plans to enrol at least 500 participants, who could not experience an adequate response to standard psychiatric management, at around 80 sites across various countries.
The first patient for the study has been already recruited at the Universitätsklinikum Jena in Germany.
During the study, patients will be implanted with the therapy and undergo follow-up for a minimum of three years and a maximum of five to monitor changes in clinical symptoms due to the VNS Therapy.
The study will measure response at one year as the primary endpoint, along with secondary endpoints and factors such as quality of life, patient function and adjunctive antidepressant treatments.
LivaNova Clinical, Regulatory and Quality senior vice-president Bryan Olin said: “This post-market study will allow us to have a better understanding of this treatment-resistant patient population and the significant role VNS Therapy can play in the overall management of this disease.
“RESTORE-LIFE is unique in the fact that clinical response, patient functioning and resource utilisation will be followed up globally for five years, amassing high-quality, real-world clinical data on VNS Therapy as an adjunctive treatment for difficult-to-treat depression.”