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Cyberonics, Inc. (2004): FDA ignores panel recommendation and determines cyberonics’ expedited review depression PMA-supplement not approvable. Press Release, August 12, 2004. Available at: http://www.cyberonics.com/PressRelease_detail.asp?ID=DAE078D5-911D-47C7-991F-7B38DB094DCC. Accessed September 20, 2005.
Cyberonics, Inc. (2005): FDA deems cyberonics’ VNS therapy system approvable for chronic or recurrent treatment-resistant depression (TRD). Press Release, February 2, 2005. Available at http://www.cyberonics.com/PressRelease_detail.asp?ID=E7C61130-4364-4372-9B66-C6B7E33CC895. Accessed April 1, 2005.
Food and Drug Administration. Final Statistical Summary Review for PMA P970003/S50 (Original and Various Amendments), Vagus Nerve Stimulator (VNS) Therapy System for Depression, Cyberonics, Inc. Available at: http://www.fda.gov/ohrms/dockets/ac/04/briefing/4047b1.htm. Accessed September 20, 2005.
- A one-year comparison of vagus nerve stimulation with treatment as usual for treatment-resistant depression.Biol Psychiatry. 2005; 58: 364-373
- Vagus nerve stimulation for treatment-resistant depression: a randomized, controlled acute phase trial.Biol Psychiatry. 2005; 58: 347-354
- Effects of 12 months of vagus nerve stimulation in treatment-resistant depression: a naturalistic study.Biol Psychiatry. 2005; 58: 355-363
United States Senate Committee on Finance (2006): Review of the FDA’s approval process for the vagus nerve stimulation therapy system for treatment-resistant depression. February 2006. Available at http://finance.senate.gov/press/Gpress/02_2006%20report.pdf.
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- ReplyBiological PsychiatryVol. 60Issue 12
- PreviewIt is beyond our expertise to discuss the Food and Drug Administration (FDA) processes involved in the ultimate approval of vagus nerve stimulation (VNS) for treatment-resistant depression (TRD). The evidence, however, presented in the three articles includes some but not all of the data on VNS available to the FDA. The findings taken together must be understood in the context of the expected course of chronic or recurrent mood disorders and additional preclinical evidence of the antidepressant effects of VNS (Ben-Menachem et al 1995; Carpenter et al 2004; George et al 2000; Krahl et al 1998, 2004; Walker et al 1999).