FDA approves Cyberonics Aspire High Capacity generator for vagus nerve stimulation therapy

Feb 2 2011

Cyberonics, Inc. (Nasdaq: CYBX) today announced that the AspireHC™ (High Capacity) generator for use in vagus nerve stimulation (VNS) therapy was approved by the United States Food and Drug Administration (FDA) for commercial release.

The AspireHC generator (development name NXT HC) represents the fifth generation of VNS Therapy® technology.  This product incorporates greater functionality for the benefit of patients and their physicians, including longer battery life, improved electronics and simplified features for programming.  

The AspireHC generator is expected to be in limited commercial release in the United States in the Company's current quarter ending April 29, 2011.  The company has applied for the CE Mark.

"The AspireHC generator will enhance the quality of life for VNS patients, and we are gratified that the FDA completed their review in an expeditious manner," said Dan Moore, Cyberonics' President and Chief Executive Officer.  "In addition, this generator provides an important platform for future new product introductions, including the AspireSR seizure response system for which a European clinical trial is planned to start in the first half of calendar 2011."  

To date, more than 60,000 patients worldwide have been implanted with the VNS Therapy System for epilepsy.