Cyberonics epilepsy therapy gets panel nod
WEBSTER, Texas, June 27 (Reuter) - Cyberonics Inc said Friday that a Food and Drugs Administration panel has unanimously recommended to the full agency approval of the company's epilepsy therapy known as NeuroCybernetic Prosthesis system.
The company said it is seeking approval of the system for use in reducing the frequency of seizures in adults and adolescents who are more than 12 years old.
It said the the system could be used as an adjunctive therapy for patients with partial onset seizures..
Robert Cummins, president and chief executive officer, said the company was delighted at the FDA panel's approval, which he said came in less than six months after the company submitted its application.
William Duffell, the company's vice president for regulatory and clinical affairs, said Cyberonics looks forward to working with the FDA to implement the panel's recomendations and complete the approval possible. |