UK-based medical technology company LivaNova has enrolled the first patient in RECOVER clinical study to evaluate Vagus Nerve Stimulation (VNS) Therapy for Treatment-Resistant Depression (TRD).
RECOVER is a prospective, multi-centre, randomised controlled blinded trial designed to evaluate the safety and effectiveness of VNS Therapy System as adjunctive therapy compared to a no stimulation control in subjects with treatment-resistant depression (TRD).
LivaNova chief executive officer Damien McDonald said: “With the enrollment of the first patient in RECOVER, we are on a pathway to better address treatment for depression, which is the leading cause of disability in the U.S. We are committed to this journey and to the patients who seek and deserve better forms of treatment.”
RECOVER is a double-blind, randomised, placebo-controlled study
The RECOVER study is aimed at determining the effectiveness of active VNS Therapy treatment compared to a no stimulation control in the reduction of baseline depressive symptom severity, enrolling up to 500 unipolar and up to 500 bipolar patients at 100 sites in the US, with at least one-year follow-up.
The study is conducted in accordance with the US Centres for Medicare & Medicaid Services (CMS) National Coverage Determination, a part of Evidence Development Program.
The VNS Therapy System is advised for the treatment of chronic or recurrent depression for patients aged 18 years or older, with a major depressive episode and unresponsive to four or more adequate antidepressant treatments.
The therapy has secured CE Mark in 2001 and the US Food and Drug Administration (FDA) approval in 2005 for the treatment of depression, while FDA has recently approved Symmetry as the latest VNS Therapy System for Depression.
The VNS Therapy System has common side–effects, including hoarseness, shortness of breath, sore throat and coughing, which typically occur during stimulation and decrease over time.
LivaNova depression vice-president Jonathan Walker said: “Symmetry is the first and only FDA-approved implantable device specifically designed for depression that is difficult to treat. We are pleased that the latest model of our VNS Therapy System, Symmetry, is now available as an option for patients.”
