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Cyberonics Nabs Approval For Depression Device, Plans For Reimbursement

This article was originally published in The Gray Sheet

Executive Summary

Cyberonics predicts reimbursement for VNS Therapy for treatment-resistant depression (TRD) will be fully secured by 2007, despite encountering protracted difficulties in gaining FDA approval

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Research In Brief

VNS postmarket study: Multicenter, double-blind randomized dosing study (D-21) showed that at 50 weeks, treatment with Cyberonics' VNS Therapy vagus nerve stimulation system improved overall depression symptoms by 32.4%-42%, based on the Montgomery-Asberg Depression Rating Scale, the firm reports May 27. The study was a condition of FDA approval in 2005 for patients with chronic and recurrent treatment-resistant depression (1"The Gray Sheet" July 25, 2005). D-21 compared adjunctive VNS Therapy administered at three stimulation levels (low, medium or high) in 331 patients for 22 weeks. Patients receiving high stimulation did not show significantly greater improvement than those receiving low or medium stimulation at the end of the 22-week acute phase. The study design allowed patients in low and medium groups to receive increased levels of stimulation after 22 weeks

Research In Brief

VNS postmarket study: Multicenter, double-blind randomized dosing study (D-21) showed that at 50 weeks, treatment with Cyberonics' VNS Therapy vagus nerve stimulation system improved overall depression symptoms by 32.4%-42%, based on the Montgomery-Asberg Depression Rating Scale, the firm reports May 27. The study was a condition of FDA approval in 2005 for patients with chronic and recurrent treatment-resistant depression (1"The Gray Sheet" July 25, 2005). D-21 compared adjunctive VNS Therapy administered at three stimulation levels (low, medium or high) in 331 patients for 22 weeks. Patients receiving high stimulation did not show significantly greater improvement than those receiving low or medium stimulation at the end of the 22-week acute phase. The study design allowed patients in low and medium groups to receive increased levels of stimulation after 22 weeks

Cyberonics Not Banking On Expanded VNS Therapy Coverage In 2006

Cyberonics projects no further coverage decisions in 2006 for its VNS Therapy for treatment-resistant depression (TRD) and has lowered its revenue projections accordingly

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