Cyberonics Provides Business Update on Depression Clin...( HOUSTON Jan. 7 /- Cyberonics Inc. (Na...)

HOUSTON, Jan. 7 /PRNewswire-FirstCall/ -- Cyberonics, Inc. (Nasdaq: CYBX) today announced that it has made a proposal to the U.S. Food and Drug Administration ("FDA") to amend the protocol of its post-market dosing study (D-21) in depression patients treated with VNS TherapyTM.

Based on a reassessment of the study power and size following the FDA's approval of an amendment to the data analysis originally specified in the study protocol, the company proposes to reduce the number of study subjects from 460 to 330, while still maintaining appropriate study power. The company expects to meet this revised enrollment level within one to two months and will thereafter suspend further patient enrollment pending FDA's decision on its proposed amendment, which was submitted in November 2008. The company expects to complete the follow-up on all patients enrolled in the study. At this time, the company does not know when to expect a decision from the FDA.

About Cyberonics, Inc. and VNS TherapyTM

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(TM) System, which is FDA-approved for the treatments of refractory epilepsy and treatment-resistant depression. The VNS Therapy System uses a surgically implanted medical device that delivers pulsed electrical signals to the vagus nerve. Cyberonics markets the VNS Therapy System in selected markets worldwide.

Additional information on Cyberonics, Inc. and VNS Therapy(TM) is available at www.cyberonics.com and www.vnstherapy.com'/>"/>