FDA approves Demipulse and Demipulse Duo Generators for use in vagus nerve stimulation

Jul 17 2007

Cyberonics, Inc. has announced that the Demipulse and Demipulse Duo Generators for use in Vagus Nerve Stimulation ("VNS") Therapy were approved by the United States Food and Drug Administration ("FDA") for commercial release.

The Demipulse generators are the next generation of VNS Therapy technology. These products are 43% smaller in volume than the Model 102 generators and incorporate greater functionality for the benefit of patients and their physicians, including continuous projection of time to end of service, improved diagnostics, such as direct lead impedance measurement, and faster communication with a programming system. The Demipulse generators also provide a platform for the introduction of additional features and functionality in the future.

The Demipulse models, currently in limited release in Europe, are expected to be in limited commercial release in the United States late in the Company's fiscal second quarter at a premium to the Model 102 pricing.

"We believe the Demipulse generators will enhance both the quality of life for our patients, as well as allow for improved physician monitoring of implanted devices. We are excited that this approval coincides with the 10th anniversary of the original FDA approval of VNS Therapy for treating pharmacoresistent epilepsy," said Dan Moore, Cyberonics' President and Chief Executive Officer.

More than 45,000 patients have benefited from VNS Therapy during the past 10 years.