Media contacts: USF Health Public Affairs
Susanna Martinez,
(813) 974-3300 or smartin1@hsc.usf.edu
Christie Marzelli
Schwartz Communications
(781) 684-0770
>>USF Health offers VNS Therapy for patients with treatment-resistant depression
|
TAMPA, FL (Oct. 17, 2005) -- The University of South Florida is the first in the Tampa area to offer vagus nerve stimulation (VNS) Therapy, a long-term treatment specifically approved by the FDA for treatment-resistant depression (TRD). VNS therapy is approved as a long-term adjunctive treatment for patients 18 years of age and older who are experiencing a major depressive episode and have not responded to four or more adequate antidepressant treatments. VNS Therapy was approved for the treatment of drug-resistant 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 four million people, experience depression that does not respond to multiple antidepressant treatments. For these people, psychotherapy, antidepressant medications and sometimes even electroconvulsive therapy do not work. While these treatments may work for a short while, they stop working over time. VNS Therapy is an important treatment option for these patients. "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 Francisco Fernandez, MD, chair of psychiatry at USF Health. "It is especially important to know that 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." In clinical studies, more than half of the patients who 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 was 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. "Over the last five years, I have implanted more than 100 epilepsy patients with VNS therapy," said USF's Fernando Vale, MD, who will be implanting the device at Tampa General Hospital. "This procedure, which is exactly the same for implanting TRD patients, is straight forward and quick." 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, run s 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, ask your doctor, visit www.vnstherapy.com or call 1-877-NOW-4-VNS. - USF - ABOUT USF HEALTH USF Health at the University of South Florida is dedicated to making life better by improving health in the wider environment, in communities, and for individuals. USF Health has, as its core, the three colleges of Public Health, Nursing and Medicine, including a School of Physical Therapy, as well as the healthcare delivered by its clinicians. Originally founded as the USF Medical Center in 1965, its name has been changed to USF Health to reflect its collaborative focus on the full continuum of health. In partnership with its affiliated hospitals, USF Health's research funding last year was $134 million -- more than half of which came from federal sources. USF Health's colleges serve more than 2,500 students and its practitioners oversee 396,000 outpatient visits a year. ABOUT USF HEALTH 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 System TM, 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. 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. 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.
|



