• The First New, FDA-Approved Approach to Treating Epilepsy in 100 Years
  • Vagus Nerve Stimulation (VNS) with the Cyberonics NeuroCybernetic Prosthesis (NCP®) System is the first new approach to the treatment of epilepsy in over 100 years. After 15 years of research and clinical studies, VNS was approved by the US Food and Drug Administration (FDA) on July 16, 1997 as an add-on therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures which are refractory to antiepileptic medi-cations. To date, over 3,000 patients of all ages with a variety of seizure types have been treated by physicians at over 300 centers in the United States and Europe.
  • Seizure control for many patients improves over time.Five clinical studies involving 454 patients were conducted to evaluate the safety and effectiveness of VNS. Similar to drug studies, the initial evaluation period for most of these studies was three months. At the end of the three-month acute phase, over 97% of patients elected to continue with VNS. Long term results suggest that the efficacy of VNS is maintained and for many patients may improve over time.
  • Unique Side Effect Profile
    • Unlike most antiepileptic drugs, VNS is not associated with toxic central nervous system side effects such as memory loss, confusion, sedation and inability to concentrate. The four most frequently reported side effects of VNS are voice change, throat discomfort, a feeling of shortness of breath and cough. These side effects typically occur only when stimulation is "ON" and not during the "OFF" period. Patient satisfaction with VNS is reflected by patient continuation rates that were 97% at one year, 85% at two years and 72% at three years.
  • VNS is not a cure for epilepsy and does not work for everyone. Physicians involved in the studies cite the "Rule of Thirds" regarding long term patient outcome. According to these physicians, one-third of patients treated with VNS as part of their long-term treatment regimen experienced a profound improvement in overall quality of life, one-third experienced a good improvement in overall quality of life and one-third experienced little or no improvement. Currently, there is no way to determine which patients will respond to VNS or how quickly a patient may respond to therapy.
  • Most of the clinical trials for vagal nerve stimulation focused on patients with partial seizures. The just published the results of the experience at New York Hospital-Cornell suggests that VNS is extremely helpful for generalized epilepsies.The New York Hospital-Cornell Epilepsy Center has trials currently in progress to examinie details of different stimulation frequencies and settings, in an effort to rigorously establish guidelines for most efficacious seizure control.
  • Lower Mortality Risks - Sudden Unexplained Death in Epilepsy Population
    • Mortality/SUDEP study to FDA (6/97) Epilepsia (2/98) Annegers, Hauser
      • ~800 patients, ~1,400 patient years VNS SMR (5.3/1,000 yrs) and SUDEP rates (4.5/1,000 yrs) consistent with refractory epilepsy population
    • Two year follow-up study completed Epilepsia, AES 99 Annegers, Coan
      • ~1,800 patients, ~3,200 patient years 30% lower SMR (3.6/1,000 yrs)
      • Lower SUDEP rates after two years of VNS (1.7/1,000 yrs > 2 yrs vs. 5.5 < 2 Yrs)
  • American Academy of Neurology Reassessment
    • “Preponderance of Class I Evidence Shows that VNS for Epilepsy is Safe and Effective” (Neurology, Vol. 53, p. 666-669, 1999)
  • VNS Consensus
    • Seizure Control AND Quality of Life:
      • Treats seizures short term
      • No CNS side effects
      • Treats seizures long term
      • Offers Quality of Life enhancing side benefits
      • Lower mortality risks
      • No “Black Box Warning”
      • Cost effective
        

Long Term Symptomatic Relief

• Improved Quality of Life Outcomes Noted:
  • Less severe, shorter seizures
  • Better mood
  • Improved alertness
  • Better post-ictal state
  • Better memory
  • Improved cognition
  • Magnet = control
  • Fewer ER visits
• VNS Consensus
  • Seizure Control AND Quality of Life
    • Treats seizures short term
    • No CNS side effects
    • Treats seizures long term
    • Offers Quality of Life enhancing side benefits
    • Lower mortality risks
    • No “Black Box Warning” frequently associated with medication
    • Cost effective
      

Published VNS Results

VNS EO1/EO2
VNS EO3
VNS EO4
VNS EO5
VNS Long Term Results (E01-EO5)
VNS & Adolescence
VNS Post Approval Results
VNS Patient Outcome Registry

Benefits of VNS: Effectively treats seizures short term without CNS side-effects commonly associated with antiepileptic drug therapy Offers seizure control which is maintained, and for some, improves over time Performs better in routine clinical use (Patient Outcome Registry Data) than in early clinical studies In addition to seizure control, some patients report improvement in alertness, post-ictal periods, mood, clusters, verbal skills, sense of control Does not carry a “Black Box Warning” regarding potential life threatening side effects Provides the unique advantages of a device based treatment Long lasting, “hassle-free” therapy Guaranteed Compliance Convenient, magnet activated “on-demand” therapy = patient and family control Targeted therapy and few side effects = No “other system” effects No interactions Provides participating clinicians with unrestricted access to a Patient Outcome Registry Patient demographics, medical histories, drug dosages, stimulation parameters, seizure data and quality of life measures at baseline and 3, 6, 12, 18 and 24 months Know your patients’ outcomes Know the National routine clinical use experience: search the National database to improve patient selection, treatment decisions and patients’ outcomes Know the true long-term effectiveness and value of VNS

VNS Therapy: Conclusions Unique therapy for epilepsy, with efficacy and safety established in two controlled studies. Effective long-term, adjunctive treatment for partial seizures. Side effects are well-tolerated and generally decrease with time. VNS does not replace antiepileptic medications; however, it is a welcome addition to the armamentarium of antiepileptic therapies.