LivaNova PLC ("LivaNova" or the "Company"), a market-leading medical technology company, today announced the launch and enrollment of the first patient in the Global Prospective, Multi-center, Observational Post-market Study to Assess Short-, Mid- and Long-term Effectiveness and Efficiency of Vagus Nerve Stimulation Therapy® ("VNS Therapy") as Adjunctive Therapy in Real-world Patients with Difficult to Treat Depression ("RESTORE-LIFE"). This study will evaluate the use of LivaNova's VNS Therapy System in patients who have treatment-resistant depression ("TRD") and have failed to achieve an adequate response to standard psychiatric management.
The first patient for RESTORE-LIFE was enrolled by Prof. Karl-Jürgen Bär, Psychiatrist at the Universitätsklinikum Jena in Germany. "Treatment-resistant depression, or difficult-to-treat depression, is an area of mental health in need of additional proven treatment options. Up to one-third of patients suffering from depression do not respond to several attempts at treatment," said Bär. "This real-world study will help further define the near- and long-term benefits of VNS Therapy as an adjunctive treatment within this patient population."
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 Åsberg Depression Rating Scale ("MADRS") of at least 50 percent 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.
"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," said Bryan Olin, LivaNova's Senior Vice President of Clinical, Regulatory and Quality. "RESTORE-LIFE is unique in the fact that clinical response, patient functioning and resource utilization 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."
VNS Therapy received CE Mark in 2001 and U.S. Food and Drug Administration approval in 2005 for TRD. The system consists of two implantable components: a programmable electronic pulse generator that is connected to a bipolar electrical lead, which sends mild pulses to stimulate the vagus nerve at regular intervals throughout the day.