On June 2 at 8:00 pm ET, Reuters news service issued a press release announcing that the FDA have nearly completed the final review of the conditions set out in the February “deemed approvable letter” for VNS therapy as a treatment for chronic depression. Cyberonics Inc. said the FDA had nearly completed final review of the conditions described in the approval in February of implanted device to treat chronic depression. The FDA approved the VNS Therapy System, pending final labeling, protocols for post-marketing study of dosage and patient records, as well as resolution of manufacturing problems and outstanding issues of clinical trials. The company said a follow-up inspection of its headquarters from Houston will begin on Monday. He also said that four manuscripts of clinical trials of the product was accepted for publication in peer respected psychiatric journals.
In a communique, President Executive Skip Cummins said the company expects to launch sales of the devices for “treatment resistant depression” once minor changes are made to the label and follow-up inspection has been completed successfully. Cyberonics also said it has entered into a formal quiet period with respect to all public communications pending a final decision by the FDA or other material information requiring disclosure.In a statement, Chief Executive Skip Cummins said the company expects to launch sales of the devices for “treatment resistant depression” once minor changes are made to the label and follow-up inspection has been completed successfully. Charles Donovan was a patient in the research process from the FDA for vagus nerve stimulation and depression. After 25 years of chronic depression, vagus nerve stimulation completely cured his chronic depression. The author is so grateful and honored by this extraordinary device. The trip is chronicled in his book Out of The Black Hole: