Cyberonics Confirms Safety and Efficacy of VNS Therapy®

HOUSTON, Nov. 5, 2010 /PRNewswire/ -- To correct and clarify assertions and implications included in some recent media reports, Cyberonics, Inc. (Nasdaq: CYBX) today confirmed the safety and efficacy of its vagus nerve stimulation (VNS) Therapy by emphasizing that VNS Therapy is an important treatment option for patients with epilepsy who have tried and failed multiple medications and for whom brain surgery is not an option.  Approximately 60,000 patients have been implanted with VNS Therapy worldwide over the past 16 years.

The company noted that uncontrolled epilepsy is life-threatening and puts patients at increased risk for accidental death and sudden unexpected death from epilepsy (SUDEP).  VNS Therapy, in combination with epilepsy medication, provides a safe and effective means of combating drug-resistant epilepsy for these patients.

Specific to the incorrect and misleading media assertions, Cyberonics stated that:

• It is not aware of any death of an epilepsy or depression patient caused by VNS Therapy.
• In seven pre-approval clinical studies involving more than 700 patients and two post-approval clinical studies involving more than 300 additional patients, it collected, analyzed, and submitted morbidity and mortality data to the U.S. Food and Drug Administration (FDA).
• Available data demonstrate that all-cause mortality rates for VNS Therapy patients with epilepsy are less than half the rates in the comparable non-VNS epilepsy patient population (6.8 vs 14-19 per 1,000 patient years). Additionally, the rates of SUDEP for VNS Therapy patients are less than half the rates in the comparable non-VNS epilepsy patient population (4.1 vs 9.3 per 1,000 patient years).
• Safety and efficacy is clearly demonstrated in both pre-approval epilepsy studies as well as longer-term follow-up studies:
  • Pre-approval epilepsy studies included two randomized controlled clinical studies in which 23%-30% of patients experienced a reduction in seizure frequency by at least half.
  • Subsequent studies showed that 40%-60% of patients may achieve comparable levels of response.  
  • The benefits of VNS Therapy are further reinforced by the 70% of patients who choose to have their generator replaced when the battery is depleted.

Cyberonics concluded by noting its long tenure as a leader in the field of devices for epilepsy, and that it is proud of its proven record of helping to improve the lives of patients with epilepsy.

About Cyberonics, Inc. and VNS Therapy®

Cyberonics, Inc. (Nasdaq: CYBX) is a medical technology company with core expertise in neuromodulation.  The company developed and markets the Vagus Nerve Stimulation (VNS) Therapy System, which is FDA-approved for the treatment of refractory epilepsy and treatment-resistant depression.  The VNS Therapy System uses a surgically implanted medical device that delivers electrical pulsed signals to the vagus nerve.  Cyberonics markets the VNS Therapy System in selected markets worldwide.

Additional information on Cyberonics and VNS Therapy is available at www.cyberonics.com.

SOURCE Cyberonics, Inc.