A Medical Device Daily
Cyberonics (Houston) reported on Wednesday, during a conference call with the FDA's Dallas District Office, that the agency found its response to an FDA Warning Letter, dated Dec. 22, 2004, to be "complete and adequate."
During the conference call, the district said that it had notified the Center for Devices and Radiological Health (CDRH) that the Warning Letter case file has been administratively closed and that Cyberonics will receive a letter confirming this.
"Cyberonics is very pleased that the Warning Letter is no longer an issue for all VNS Therapy stakeholders and that one of the four conditions of final approval of the Expedited Review Depression PMA-Supplement has been satisfied," said Skip Cummins, Cyberonics' CEO and chairman. He termed the news a "major step forward towards the accomplishment of Cyberonics' mission to improve the lives of people touched by refractory epilepsy and treatment-resistant depression [TRD] would not have been possible without the timely, diligent, interactive and cooperative efforts of the entire Dallas District Office staff."
He added: "Cyberonics and CDRH continue to make good progress towards our goal of satisfying the remaining conditions of final TRD approval."
Cyberonics develops medical devices for the long-term treatment of epilepsy, depression and other chronic neurological disorders using the VNS (vagus nerve stimulation) System, an implantable generator similar to a cardiac pacemaker. The system was approved by the FDA in 1997 for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications. The system also is approved for sale as a treatment for epilepsy in all the member countries of the European Economic Area, Canada, Australia and other markets.