Healthcare Industry News:  VNS Therapy 

Devices Neurology

 News Release - May 19, 2006

Cyberonics Provides Update on Annual American Psychiatric Association Meeting Activities and Recent VNS Therapy Publications

Significant New Findings on Long-Term Safety and Effectiveness and Mechanism of Action

HOUSTON, May 19 (HSMN NewsFeed) -- Cyberonics, Inc. (Nasdaq: CYBX ) today announced that VNS Therapy for TRD will have a significant presence at American Psychiatric Association (APA) Meeting, May 20-25, 2006 in Toronto, Canada. VNS Therapy will be the topic of five poster presentations, an industry-sponsored symposium and a CME course at the annual meeting.

On Saturday, May 20 from 6:00 pm - 9:00 pm, Cyberonics is sponsoring an industry-sponsored symposium titled, "Treatment-Resistant Depression: New Data, New Approaches." David L. Dunner, M.D., Director, Center for Anxiety and Depression, Professor, Department of Psychiatry and Behavioral Sciences, University of Washington, will serve as the moderator. The symposium speakers will present new findings on TRD and various treatment options and strategies including VNS Therapy.

VNS Therapy and TRD will also be the subject of five APA poster presentations by psychiatric experts specializing in TRD, treatment algorithms and mechanism of action research. The presentations will include new data on VNS Therapy's durability of response, mechanism of action, and favorable impact on suicidality and worsening depression, as well as the ineffectiveness of treatment-as-usual excluding VNS Therapy in TRD.

Psychiatric experts on VNS Therapy and TRD will also be on hand at the Cyberonics APA Booth #1576 to discuss experiences with VNS Therapy and to answer questions on VNS Therapy mechanism of action, safety and tolerability, durability of response and high continuation and adherence rates. Additionally, a CME course on VNS Therapy for TRD, lead by Ziad H. Nahas, M.D., Associate Professor, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, will provide psychiatrists with an understanding of VNS Therapy as a new treatment option for TRD.

Recent peer-reviewed data published in several leading psychiatric journals including Biological Psychiatry and the Journal of Clinical Psychiatry confirm the association of VNS Therapy with significant antidepressant benefits that are sustained and/or increase over time for patients with chronic or recurrent treatment-resistant depression. Recent articles on the safety, effectiveness and unique mechanism of action of VNS Therapy include:

* "VNS Therapy in treatment-resistant depression: clinical evidence and
putative neurobiological mechanisms." Neuropsychopharmacology. 2006.
Nemeroff CB, Mayberg HS, Krahl SE, et al.

* "Effect of Vagus Nerve Stimulation on serotonergic and noradrenergic
transmission." J Pharmacol Exp Ther. 2006. Dorr AE, Debonnel G.

* "Vagus Nerve Stimulation (VNS) and Treatment of Depression: To the
Brainstem and Beyond. "Psychiatry 2006, John P. O'Reardon, MD; Pilar
Cristancho, MD; and Andrew D. Peshek, MD

* "A one-year comparison of vagus nerve stimulation with treatment as
usual for treatment-resistant depression." Biological Psychiatry.
George MS, Rush AJ, Marangell LB, et al. 2005;58:364-373.

* "Vagus nerve stimulation for treatment-resistant depression: a
randomized, controlled acute phase trial." Biological Psychiatry. Rush
AJ, Marangell LB, Sackeim HA, et al. 2005;58:347-354.

* "Effects of 12 months of vagus nerve stimulation in treatment-
resistant depression: a naturalistic study." Biological Psychiatry.
Rush AJ, Sackeim HA, Marangell LB, et al. 2005;58:355-363.

* "Vagal nerve stimulation: a review of its applications and potential
mechanisms that mediate its clinical effects." Neuroscience &
Biobehavioral Reviews. Groves DA, Brown VJ. 2005;29:493-500.

* "Pregnancy and delivery while receiving vagus nerve stimulation for
the treatment of major depression: a case report." Annals of General
Psychiatry. Husain MM, Stegman D, Trevino K. 2005;4:16.

* "Two-year outcome of vagus nerve stimulation (VNS) for treatment of
major depressive episodes." Journal of Clinical Psychiatry. Nahas Z,
Marangell LB, Husain MM, et al. 2005;66:1097-1104.

* "Vagus nerve stimulation. Surgical option for treatment-resistant
depression." Current Psychiatry. Rado J, Janicak PG. 2005;4:78-82.

* "Vagus nerve stimulation: a new tool for treating depression." Primary
Psychiatry. Marangell LB, Martinez M, Martinez JM, George MS, Sackeim
HA. 2005;12:40-43.

* "Vagus Nerve Stimulation (VNS) is effective in a rat model of
antidepressant action." J Psychiatr Res. 2004;38:237-240. Krahl SE,
Senanayake SS, Pekary AE, Sattin A.

* "Changes in hypothalamic-pituitary-adrenal axis measures after Vagus
Nerve Stimulation Therapy in chronic depression." Biol Psychiatry.
2005;58:963-968. O'keane V, Dinan TG, Scott L, Corcoran C.

* "Changes in regional cerebral blood flow by therapeutic Vagus Nerve
Stimulation in depression: An exploratory approach." Psychiatry Res.
2005;139:165-179. Zobel A, Joe A, Freymann N, et al.

* "The effects of Vagus Nerve Stimulation on pro- and anti-inflammatory
cytokines in humans: a preliminary report." Neuroimmunomodulation.
2005;12:307-309. Corcoran C, Connor TJ, O'keane V, Garland MR.

* "Cerebral blood flow changes during Vagus Nerve Stimulation for
depression." Psychiatry Res. 2006;142(2):179-184. Conway CR, Sheline
YI, Chibnall JT, George MS, Fletcher JW, Mintun MA.

* "Neurostimulation in resistant depression." J Psychopharmacol.
2006;20(suppl):35-40. Carpenter LL.

* "Vagus Nerve Stimulation and deep brain stimulation for treatment
resistant depression." Med Health R I. 2006;89:137, 140-1. Carpenter
LL, Friehs GM, Tyrka AR, Rasmussen S, Price LH, Greenberg BD.

* "Vagus Nerve Stimulation Therapy in a patient with treatment-resistant
depression: a case report of long-term follow-up and battery end-of-
service." CNS Spectr. 2006;11:143-147. Martinez JM, Zboyan HA.

* "Advances in the treatment of depression." NeuroRx. 2006;3:42-56.
Holtzheimer PE 3rd, Nemeroff CB.

* "Neural circuitry and neuroplasticity in mood disorders: insights for
novel therapeutic targets." NeuroRx. 2006;3:22-41. Carlson PJ, Singh
JB, Zarate CA Jr, Drevets WC, Manji HK.

* "Recent progress in pharmacological and non-pharmacological treatment
options of major depression." Curr Pharm Des. 2006;12:503-515. Baghai
TC, Moller HJ, Rupprecht R.

"The rapidly growing body of valid scientific evidence confirms the safety, effectiveness and cost effectiveness of VNS Therapy as a treatment for TRD," commented Richard L. Rudolph, M.D., Cyberonics' Vice President, Clinical and Medical Affairs and Chief Medical Officer. "In addition to the evidence presented at APA and already published, some twenty new VNS publications are in process on a variety of subjects including the two-year data from our international TRD study, new findings from mechanism of action research and the pharmaco-economics of VNS Therapy and treatment-as-usual in TRD."

The 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 the first FDA-approved implantable device-based treatment for depression and the first treatment developed, studied, approved and labeled specifically for patients with treatment-resistant depression (TRD).

To date, more than 5,000 psychiatrists have been trained at Cyberonics- sponsored medical education programs, 2,650 psychiatrists have identified over 10,000 potential VNS patients, 180 different payers have approved individual case-by-case use of VNS Therapy, 1,100 patients have been treated with VNS Therapy and approximately 4,700 patients have been denied access to VNS Therapy by their insurance providers. The Company is actively working with psychiatrists, patients, patient advocacy organizations, employers and payers to provide psychiatrists and patients with TRD the same universal access to VNS Therapy enjoyed by neurologists and their epilepsy patients through broad- based coverage policies for the past six years.

VNS Therapy was 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 in July 1997. In addition to treatment-resistant depression and pharmacoresistant epilepsy indications, VNS Therapy is at various stages of research as potential treatments for anxiety disorders, Alzheimer's disease, bulimia, chronic headache/migraine, morbid obesity, and multiple sclerosis.

In total, more than 40,000 patients have accumulated over 100,000 patient years of experience with VNS Therapy.


Information on Cyberonics, Inc. and VNS Therapy is available at and .

Source: Cyberonics

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