SEATTLE, Oct. 28, 2005 - The Seattle Neuroscience Institute (SNI) at Swedish Medical Center today became the first program in Washington state to begin offering VNS (vagus nerve stimulation) Therapy as a long-term treatment specifically approved by the FDA for treatment-resistant depression (TRD). VNS Therapy is approved as a long-term adjunctive (add-on) treatment for patients 18 years of age and older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments. VNS Therapy was approved for the treatment of pharmacoresistant epilepsy in 1997, and is now the first treatment specifically studied and approved for TRD.
Major depressive disorder is one of the most prevalent and serious illnesses in the United States, affecting nearly 19 million Americans every year. Of those, 20 percent, or approximately 4 million people, experience depression that does not respond to multiple antidepressant treatments. For these people, treatments including psychotherapy, antidepressant medications - and even sometimes electroconvulsive therapy - do not work, or they either work for a short while or stop working over time. VNS Therapy is an important treatment option for these people.
In clinical studies of VNS Therapy, more than half of the patients who had experienced an average of 25 years of major depressive disorder and multiple treatment trials realized some clinical benefit, one third of the patients had at least a 50-percent improvement in their depression, and one out of six were depression-free after one year and two years of treatment with VNS Therapy. Patients also reported significant improvements in quality-of-life areas, such as vitality, mental health, emotional well-being, and social functioning.
"Patients with TRD need additional options. The availability of VNS Therapy is an important treatment option for millions of people who, until now, have not had access to a proven long-term option to control depressive symptoms," said SNI Neurosurgeon Ryder Gwinn, M.D., who performed Swedish's first VNS for TRD implant procedure. "It's especially important to know clinical-study results have shown that patients achieve increasing benefits from VNS Therapy over time and experience sustained results. Additionally, VNS Therapy is very tolerable, and side effects typically diminish over time."
VNS Therapy is delivered from a small pacemaker-like device implanted in the chest area that sends mild pulses to the brain via the vagus nerve in the neck. A thin, thread-like wire, attached to the generator, runs under the skin to the left vagus nerve. The vagus nerve, one of the 12 cranial nerves, serves as the body's "information highway" connecting the brain to many major organs. Several studies have shown that VNS Therapy may modulate neurotransmitters such as serotonin and norepinephrine thought to be involved in mood regulation.
For more information on VNS Therapy, call Swedish's Behavioral Health Department at 206-320-4252, Cyberonics' consumer information line at 1-877-NOW-4-VNS or visit www.vnstherapy.com.
About the Seattle Neuroscience Institute at Swedish Medical Center
In 2004, Swedish Medical Center expanded its neuroscience services by establishing the Seattle Neuroscience Institute at Swedish Medical Center. The team of leading neurosurgeons and other specialists are building a world-class institute dedicated solely to the treatment and advancement of neurological disorders for patients in the Pacific Northwest and around the world. Formerly known as the Swedish Neuroscience Institute, the name was changed to reflect the program's broader scope and reach. The Swedish Medical Center/Providence Campus has been designated as the hub for the Institute and is being upgraded with four state-of-the-art operating rooms some with neuro-interventional radiology capabilities, and a renovated neuro intensive-care unit. Although the Institute is based at Swedish/Providence, neuroscience research and treatment continues to be a multi-campus program. SNI specializes in the research for and treatment of stroke, movement disorders such as Parkinson's disease, tremors and Tourette's syndrome; epilepsy; child neurological disorders; neuro-ophthalmology; headaches; multiple sclerosis and many other neurological conditions and diseases. Swedish Medical Center is the largest, most comprehensive, nonprofit health provider in the Pacific Northwest. It is comprised of three hospital campuses (First Hill, Providence and Ballard), a new community-based emergency room and specialty center in Issaquah, Swedish Home Care Services and Swedish Physicians - a network of 12 primary-care clinics. In addition to general medical and surgical care, Swedish is known as a regional referral center, providing specialized treatment in areas such as cardiac care, oncology, orthopedics, high-risk obstetrics, neurological care, sleep medicine, pediatrics, organ transplantation and clinical research. For more information, visit www.swedish.org
About VNS Therapy and Cyberonics
Cyberonics, Inc. was founded in 1987 to design, develop and market medical devices for the long-term treatment of epilepsy, depression and other chronic treatment-resistant disorders using a unique therapy, vagus nerve stimulation (VNS). Stimulation is delivered by the VNS Therapy SystemTM, an implantable generator similar to a cardiac pacemaker. The VNS Therapy System delivers preprogrammed intermittent mild electrical pulses to the vagus nerve in the patient's neck 24 hours a day. Epilepsy is a disorder characterized by recurrent seizures and is second most prevalent neurological disorder. The VNS Therapy System was approved by the FDA on July 16, 1997 for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications. The VNS Therapy System is also approved for sale as a treatment for epilepsy in all the European Economic Area, Canada, Australia and other markets. To date, more than 32,000 epilepsy patients in 24 countries have accumulated over 100,000 patient years of experience using VNS Therapy. The VNS Therapy System was approved by the FDA on July 15, 2005 "as an adjunctive long-term treatment for chronic or recurrent depression for patients 18 years of age and older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments." The VNS Therapy System has been approved for sale in the European Economic Area and in Canada as a treatment for depression in patients with treatment-resistant or treatment-intolerant major depressive episodes, including unipolar depression and bipolar disorder (manic depression) since 2001. VNS Therapy is at various levels of investigational clinical study as a potential treatment for anxiety disorders, Alzheimer's disease, chronic headache/migraine and bulimia.
- To read the transcript of a related story that KOMO Television (channel 4; ABC) aired on Oct. 27, 2005, click here.
- To read the transcript of a related story that KING Television (channel 5; NBC) aired on Oct. 28, 2005, click here.
- To read a related article published in the Oc. 29, 2005 issue of the King County Journal, click here.