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In Brief: Cyberonics

This article was originally published in The Gray Sheet

Executive Summary

Cyberonics: Submits PMA amendment to FDA for its NCP neurocybernetic prosthesis system, including information on the device's "safety and efficacy, the statistical treatment of study data, and other clinical and technical issues." FDA had requested in October that Cyberonics withdraw the PMA pending completion of an additional clinical study on the device, but the agency "has agreed" that the PMA "need not be voluntarily withdrawn" in light of the data submission. FDA also has authorized the company to begin the clinical study of an additional 200 patients, which will provide "confirmatory data" to the firm's initial clinical trial results. The implantable, vagus nerve stimulation device is intended to treat epilepsy patients "experiencing refractory partial seizures"...

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