LivaNova has announced the first patient enrolled in their RECOVER trial, a prospective, multi-centre, randomised controlled blinded trial demonstrating the safety and effectiveness of Vagus nerve stimulation (VNS) therapy as an adjunctive therapy versus a no stimulation control in subjects with treatment-resistant depression. The evaluation is in accordance with the US Centers for Medicare & Medicaid Services (CMS) National Coverage Determination as part of its coverage with evidence development programme. The first patient was enrolled by Azfar Malik in St Louis, USA.
“Through the RECOVER study, we have the ability to help patients with TRD across the USA gain access to a potentially meaningful treatment option to improve depressive symptoms and their quality of life,” says Malik, President and chief medical officer for CenterPointe Behavioural Health Systems; chair and chief executive officer of Psych Care; and clinical associate professor of Psychiatry at St Louis University. “I have had positive results treating depressed patients with VNS therapy in the past. I look forward to gaining a greater understanding of TRD and evaluating how patients respond to VNS therapy as an adjunctive treatment during this study.”
The objectives of the RECOVER study are to determine whether active VNS therapy treatment is superior to a no stimulation control in producing a reduction in baseline depressive symptom severity. The study will include up to 500 unipolar and up to 500 bipolar patients at as many as 100 sites in the USA. RECOVER is a double-blind, randomised, placebo-controlled study with a follow-up duration of at least one year. The CMS study framework also includes the possibility to extend to a prospective longitudinal study.
“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 USA,” comments Damien McDonald, chief executive officer of LivaNova. “We are committed to this journey and to the patients who seek and deserve better forms of treatment.”
While VNS therapy received CE Mark in 2001 and US Food and Drug Administration (FDA) approval in 2005 for the treatment of depression, earlier this month, the FDA approved Symmetry as the latest VNS therapy System for depression. Symmetry is indicated for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments.
“Symmetry is the first and only FDA-approved implantable device specifically designed for depression that is difficult to treat,” says Jonathan Walker, vice president of depression at LivaNova. “We are pleased that the latest model of our VNS therapy system, Symmetry, is now available as an option for patients.”