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Cyberonics gets FDA approval for nerve stimulation devices
   
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Headquartered in Houston, Cyberonics Inc. announced July 16, 2007, that the United States Food and Drug Administration approved the commercial release of the Demipulse and Demipulse Duo Generators. The products are used for vagus nerve stimulation – a treatment of epilepsy and certain types of depression.

Epilepsy is the second most prevalent neurological disorder in America, and afflicts more than 104,000 people in the city of Houston alone and 2.5 million people nationally.

Currently, the Demipulse generators are in limited release in Europe and according to Cyberonics, they are expected to be in limited commercial release in the U.S. late in its fiscal second quarter, which ends in October.

The Demipulse generators are the next generation of VNS Therapy technology. These products are 43 percent smaller than the previous model and incorporate greater functionality.

The Demipulse generators also provide a platform for the introduction of additional features and functionality in the future; more than 45,000 patients have benefited from VNS Therapy during the past 10 years.

Bay Area Houston Economic Partnership President Jim Reinhartsen said, “As Cyberonics continues to make advancements in treatments, human health and longevity, the biotechnology sector of the region gains momentum as a center of innovation and excellence.”

Cyberonics continues to play a vital role in the neuromodulation industry and the Bay Area Houston economy, employing 550 employees and annual revenue of $130 million, according to their corporate profile.

“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.