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MUSC performs first VNS prosthesis implant 

Cyberonics Inc.  announced that the first patient in the pilot study of vagus nerve stimulation (VNS) for the treatment of anxiety disorders was implanted with the NeuroCybernetic Prosthesis (NCP®) System last month at MUSC. 

The 23-year-old woman with obsessive-compulsive disorder was implanted on May 18, with no complications. She will return to the university for routine follow-up visits and treatment and will continue to be monitored frequently during the study. 

In December the United States Food and Drug Administration (FDA) granted Cyberonics an unconditional Investigational Device Exemption (IDE) for a pilot study of VNS with the NCP System in treating patients with Obsessive-Compulsive Disorder (OCD), Panic Disorder (PD) and adult onset Post-Traumatic Stress Disorder (PTSD), three of the five types of anxiety disorders. 

Up to 30 patients at four study sites will be implanted with the NCP System and stimulated with left cervical (neck area) vagus nerve stimulation. Additional study sites will be initiated in the next several weeks. 

Dr. Mark George

“The study’s first patient was successfully implanted without complication and will begin vagus nerve stimulation treatment shortly,” said Mark George, M.D., associate professor of psychiatry and behavioral sciences.  “Neurochemical analyses and brain imaging studies of patients with epilepsy and depression treated with VNS suggest that the neurochemical and brain activation effects of VNS may have beneficial effects in patients with anxiety disorders. The vagus nerve is the main pathway by which the brain receives information about heart rate and breathing, key problems in anxiety disorders. Additionally, VNS has been shown to have positive effects on mood and antidepressants are one of the primary treatments used in anxiety disorders. Despite the availability of effective treatments for anxiety disorders, only a minority of patients experience complete sustained remission and the majority remain at least somewhat symptomatic or do not improve at all. We believe it is important to study VNS as a possible treatment for anxiety disorders.”

“Cyberonics is extremely pleased to have the first patient enrolled and implanted in the anxiety pilot study after the FDA’s speedy unconditional IDE approval. The start of the anxiety pilot study is further evidence of Cyberonics’ commitment in psychiatry to develop therapies which satisfy psychiatrists, payers and patients’ long term patient care, ease of use and economics needs. The anxiety study also continues our pioneering research collaboration with Dr. Mark George and his colleagues at MUSC, where the first patient was implanted for depression just under three years ago. The world-class researchers at MUSC pioneered the clinical studies of VNS in depression and the use of neuroimaging techniques such as fMRI to understand the mechanism of VNS in depressed patients. We are privileged to be working with Dr. George and MUSC continuing our clinical and fMRI studies in depression and to now be pioneering VNS as a potential treatment for various anxiety disorders,” said Robert P. (“Skip”) Cummins, Cyberonics’ president and chief executive officer.

About Anxiety
According to the World Health Organization, anxiety disorders are the most common of all mental illnesses, affecting approximately 400 million people worldwide at any one time. 

Up to 40 million people in the United States suffer from anxiety disorders. About 20 million people in the U.S. suffer specifically from OCD, PD and PTSD. More than 1 million Americans suffer from treatment resistant anxiety. 

While each anxiety disorder has its own distinct features and symptoms, they all have in common excessive and irrational fear and dread. The majority of patients see no improvement at all or continue to exhibit at least some symptoms such as panic attacks, obsessive thoughts, flashbacks, nightmares and countless physical symptoms that interfere with everyday life. 

The estimated cost of anxiety disorders in the United States alone exceeds $40 billion per year, which includes $23.0 billion in non-psychiatric medical treatment costs, $13.3 billion in psychiatric treatment costs and $4.1 billion in indirect workplace costs. 

The U.S. market for anxiolytics, the drugs used to treat various anxiety disorders, is estimated to exceed $1.5 billion per year. Major depression is a common co-morbidity in patients with OCD, PD and PTSD. 

Recent studies suggest that 50 percent of patients with PTSD, 67 percent of patients with OCD and 50 percent to 65 percent of patients with PD also suffer from major depression in their lifetimes.