On June 2 at 8:00 pm ET, Reuters news service issued a press release announcing that the FDA have nearly completed final review of the conditions outlined in the February "deemed approvable" letter for VNS Therapy as a treatment for chronic depression. Cyberonics Inc. said that the FDA had nearly completed final review of conditions outlined in the February approval of its implanted device for treatment of chronic depression. The FDA approved the VNS Therapy System pending final labeling, protocols for a post-marketing dosing study and patient registry, as well as resolution of manufacturing issues and any outstanding clinical trial issues. The company said a follow-up inspection of its Houston headquarters will begin on Monday. It also said four manuscripts from clinical trials of the device were accepted for publication in "respected psychiatric peer-reviewed journals." In a statement, Chief Executive Skip Cummins said the company expects to launch sales of the device for "treatment-resistant depression" once minor labeling changes are made and the follow-up inspection has been satisfactorily completed. Cyberonics also said it has entered a formal quiet period with regard to all public communications pending a final FDA decision or other material information requiring disclosure. In a statement, Chief Executive Skip Cummins said the company expects to launch sales of the device for "treatment-resistant depression" once minor labeling changes are made and the follow-up inspection has been satisfactorily completed. |
