HOUSTON, Jan. 24 /PRNewswire-FirstCall/ -- Cyberonics, Inc. today announced that KEMA-Registered Quality, Inc., its European Regulatory Notified Body, recently completed a comprehensive audit of Cyberonics’ facilities and issued a certification that documents full quality systems compliance to the new ISO 13485:2003 Standard for its VNS Therapy(TM) System devices and their labeled indications for use to treat refractory epilepsy and treatment-resistant depression (TRD) as CE Marked in the European Union and Canada. This new ISO Standard is a harmonized world-wide quality management standard for the medical device industry and is compatible with the FDA Quality System Regulation.
“Cyberonics’ certification to this important new world-wide quality standard followed a comprehensive KEMA audit of our facilities and quality systems,” commented Alan D. Totah, Cyberonics’ Vice President, Regulatory Affairs and Quality. “This new, more rigorous Standard differs from the previous ISO 13485:1996 Standard with the incorporation of defined approaches to managing organizational processes with a stronger emphasis on executive management involvement and commitment to provide resources and infrastructure to maintain quality, ensure personnel training and competencies, satisfy customer needs, and maintain the effectiveness of the quality management systems. Cyberonics proactively began a company-wide project almost two years ago to prepare for the incorporation of the new ISO 13485:2003 Standard into its quality systems to assure full compliance with the new Standard upon its initial inspection by KEMA. The receipt of this important new certification assures continued patient and health care providers access to high quality and reliable VNS Therapy Systems and will facilitate the continued accomplishment of our mission to improve the lives of people touched by refractory epilepsy and treatment-resistant depression in the European Union and Canada.
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 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 Company’s initial market was 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 European Economic Area, Canada, Australia and other markets. To date, more than 32,000 epilepsy patients in 24 countries have accumulated over 94,000 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.” As part of FDA’s approval order, Cyberonics is required to conduct a 450-patient post-market dosing study and a 1,000- patient, five-year patient outcome registry. For more information on VNS Therapy for treatment-resistant depression, including the contraindications, warnings and precautions, see the Physician’s and Patient’s Manuals and other information at http://www.cyberonics.com or http://www.vnstherapy.com or call 1-877-NOW 4 VNS.
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. 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 .
Cyberonics, Inc.
CONTACT: Investor Relations of Cyberonics, Inc., +1-281-228-7262, or fax,+1-281-218-9332, or ir@cyberonics.com ; or Helen Shik, Vice President ofSchwartz Communications, +1-781-684-0770, or fax, +1-781-684-6500, orhshik@schwartz-pr.com , for Cyberonics, Inc.
