Bipolar Disorder Daily News Blog

VNS Therapy Approved in Europe

Cyberonics have received approval to start selling vagus nerve stimulation therapy (VNS) in the member countries of the European Union for treating epilepsy and depressive disorders. Bipolar disorder is one of the disorders that vagus nerve stimulation can treat.

In the United States, FDA agreed in December 2004 to review the Model 103/104 PMA-Supplement through the Real-Time Review process. Cyberonics anticipates submitting that PMA-Supplement within the next six months.

"Cyberonics is pleased to offer the next generation of VNS Generators to our epilepsy and depression customers in Europe," commented Robert P. ("Skip") Cummins, Cyberonics' Chairman of the Board and Chief Executive Officer. "We are also pleased that we now have approval for in-house sterilization of all VNS products except the Model 103 and 104 Generators in Europe. We anticipate submitting an application to KEMA for European approval of the in-house sterilization process for those generators in the near future and we anticipate that we will submit the PMA-Supplements seeking FDA approval of the Models 103 and 104 Generators and in-house hydrogen peroxide sterilization of all VNS Generators within six months of FDA's final TRD approval decision.

"The VNS Therapy System has been available in Europe to patients with pharmacoresistant epilepsy since June 1994 and to patients with treatment- resistant depression since March 2001," continued Mr. Cummins. "That experience, combined with over six-years of U.S. TRD studies and 94,000 patient years of commercial experience in over 31,000 epilepsy patients in the United States, confirms the safety and quality of the VNS Therapy System. Cyberonics looks forward to the day when all the VNS products currently available in Europe to people with epilepsy and depression are also available to Americans with those same illnesses."

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 neurological disorders using a unique therapy, vagus nerve stimulation (VNS). Stimulation is delivered by the VNS Therapy System, 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 Company's initial market is epilepsy, a disorder characterized by recurrent seizures. Epilepsy is the second most prevalent neurological disorder. The Cyberonics 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 member countries of the European Economic Area, Canada, Australia and other markets. To date, more than 31,000 epilepsy patients in 24 countries have accumulated over 94,000 patient years of experience using VNS Therapy. The VNS Therapy System was deemed approvable in writing by the FDA on February 2, 2005 as an adjunctive treatment for chronic treatment-resistant depression for adults over the age of 18. According to FDA's approvable letter, final approval was conditional on final labeling, final protocols for a post- approval dosing optimization study and patient registry, satisfactory compliance with the Quality System Regulations (QSR) and satisfactory resolution of any outstanding bioresearch monitoring issues. The VNS Therapy System is 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). 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. The Company is headquartered in Houston, Texas and has an office in Brussels, Belgium. For additional information please visit us at http://www.cyberonics.com .

For more information on vagus nerve stimulation's use for depression go to: http://biz.yahoo.com/prnews/050601/daw030.html?.v=13

For the full press release onn VNS and its approval in Europe go to: http://biz.yahoo.com/prnews/050601/daw030.html?.v=13