LivaNova (NSDQ:LIVN) said today that its vagus nerve stimulation therapy for treatment-resistant depression has won the CE Mark in Europe.
Two patients in the United Kingdom were implanted with the company’s Symmetry system 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 Dr. Andreas Papadopoulos, 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.”
Symmetry is a small implantable device designed to stimulate 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. It received 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 Dr. Edward Chisholm, the ENT surgeon who led the implant surgery, in a news release.
Some industry analysts were speculating last week that Medtronic (NYSE:MDT) might want to acquire LivaNova for its neuromodulation business. A source told financial intelligence company Reorg that someone pitched the idea to Medtronic, which would divest LivaNova’s cardiovascular business and “certain MDT cardiac surgery products.”
LivaNova also recently gained a powerful ally in its VNS research. The added Google’s (NSDQ:GOOGL) Verily to its study of vagus nerve stimulation (VNS) therapy for difficult-to-treat depression. In November, LivaNova said it was giving up on its Caisson Interventional transcatheter mitral valve replacement (TMVR) program and plans to restructure its heart valve business to improve profitability.
Major depressive disorder is a leading cause of disability, morbidity and mortality worldwide. 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, according to a 2006 study published in the Journal of American Psychiatry.
“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 LivaNova CEO Damien McDonald. “We truly appreciate the dedication and commitment it took across the NHS teams to develop a pathway connecting ENT surgical services and mental health to give more patients with depression that is difficult to treat access to this innovative therapy.”
LivaNova got a powerful ally in its VNS research in February. The company announced that it has added Google’s (NSDQ:GOOGL) Verily to its study of vagus nerve stimulation (VNS) therapy for difficult-to-treat depression. In November, LivaNova said it was giving up on its Caisson Interventional transcatheter mitral valve replacement (TMVR) program and plans to restructure its heart valve business to improve profitability.