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anxiety disorders, panic disorder, obsessive-compulsive disorder, phobias, post-traumatic stress disorder
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1,100th patient treated with VNS Therapy
1,100th Patient Treated With VNS Therapy ™ for Treatment-Resistant Depression
HOUSTON, May 1 - Cyberonics, Inc. today announced that the 1,100th patient in the U.S. has been treated with Vagus Nerve Stimulation (VNS) Therapy for treatment-resistant depression (TRD) since FDA approval in July 2005. VNS Therapy is the first FDA-approved treatment option developed, studied, approved and labeled specifically for patients with TRD.FDA approved VNS Therapy as an adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments.
VNS Therapy is also FDA-approved as an adjunctive therapy used to reduce the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications. The number of TRD patients treated with VNS Therapy in the first nine months following approval is approximately two times the number of patients with refractory epilepsy treated with VNS Therapy in the same time period following epilepsy approval in July 1997. In total, more than 40,000 patients have been treated with VNS Therapy for both indications.
Peer-reviewed data published in Biological Psychiatry and the Journal of Clinical Psychiatry confirm significant antidepressant benefits that are sustained and/or increase over time for patients with severe chronic or recurrent treatment-resistant depression. In studies of patients with an average duration of lifetime depressive illness exceeding 25 years and an average of 16 failed antidepressant treatments in their lifetimes, 56% of patients treated with adjunctive VNS Therapy realized at least a meaningful clinical benefit and almost 20% were free of depressive symptoms after two years of treatment. Sixty to seventy percent of the patients who responded after three months and after one year of VNS Therapy, maintained their response out to two years. Similar response, remission and sustained response rates have not been observed in studies of any other antidepressants in patients suffering from the same level of chronic or recurrent treatment-resistant depression included in the VNS Therapy studies.
Information on VNS Therapy is available at http://www.vnstherapy.com.
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