LivaNova’s Symmetry VNS Therapy Gains CE Mark for Difficult-to-Treat Depression

LivaNova PLC’s Vagus Nerve Stimulation Therapy (VNS Therapy) System, Symmetry, earned CE mark approval for Difficult-to-Treat Depression (DTD). Two patients in the United Kingdom were implanted at the Musgrove Park Hospital in Taunton, England, making them the first patients to receive Symmetry devices outside the United States. The ability to treat these patients with Symmetry was the result of a collaborative effort to develop a VNS Therapy for depression treatment pathway by the Somerset Partnership National Health Service (NHS) Foundation Trust, the Taunton and Somerset NHS Foundation Trust and LivaNova.
 
“With depression affecting so many people in the UK and so many patients suffering from symptoms despite traditional therapy, we were excited to develop a treatment pathway that can be replicated throughout the country, giving more patients with Difficult-to-Treat Depression access to VNS Therapy and Symmetry,” said Andreas Papadopoulos, M.D., Clinical Director at Somerset Partnership NHS Foundation Trust, who served as the referring psychiatrist. “Working with Ear, Nose and Throat (ENT) surgical services enabled us to achieve swift and expert implantation of Symmetry devices for both patients.”
 
Now available in Europe, Symmetry is a small implantable device that stimulates the vagus nerve to improve symptoms of depression and quality of life. Symmetry sends mild electric pulses to the vagus nerve, which is connected to areas of the brain that control mood. While previous models of VNS Therapy have received CE mark for the treatment of depression, Symmetry is specifically designed for the treatment of depression and is the newest VNS Therapy System. Symmetry also received U.S. Food and Drug Administration (FDA) approval in September 2019.
 
“As a surgeon, it is so gratifying to be able to help patients get access to new treatments like Symmetry given its benefit to patients’ daily lives,” said Edward Chisholm, M.D., the ENT surgeon who led the implant surgery.
 
Major depressive disorder (MDD) is a leading cause of disability, morbidity, and mortality worldwide.¹ In fact, for as many as one in three patients, medication alone may not be enough, leading them to struggle daily with persistent feelings of sadness, hopelessness, thoughts of death or suicide and overall poor health.²
 
“For the many patients around the world with depression that is difficult to treat, VNS Therapy may transform their lives by giving them relief from the symptoms they struggle with every day,” said Damien McDonald, CEO of LivaNova. “We truly appreciate the dedication and commitment it took across the NHS teams to develop a pathway connecting ENT surgic
 
References
¹ The economic burden of treatment-resistant depression. Olchanski N, McInnis Myers M, et al. Clin Ther. 2013 Apr;35(4):512-22.
² STARD: Rush AJ, Trivedi MH, Wisniewski SR, et al. Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report. Am J Psychiatry. 2006;163(11):1905–1917