FDA Approves Cyberonics VNS Device for Treatment-Resistant Depression

Following a protracted and at times contentious product review process, Cyberonics Inc. (Houston) last month received notification from FDA that the company had received final approval to market its Vagus Nerve Stimulation (VNS) device for treatment-resistant depression (TRD). The VNS device was actually approved for TRD in February, but FDA stipulated that the device could not be marketed for that indication until the company had addressed agency concerns about its manufacturing operations, product labeling, and other issues.

Last December, Cyberonics received an FDA warning letter regarding “nonconformities with current good manufacturing practice (CGMP) requirements of the quality system regulation for medical devices.” Following a series of corrective actions and improvements in the company's reporting systems, Cyberonics was notified by FDA in April that it was in full compliance with all quality systems and that the issues raised in the warning letter were fully resolved.

The April-to-July delay in granting final approval of the VNS for TRD is believed to be due, in part, to an investigation begun in May by the Senate finance committee. Although the finance committee has never publicly disclosed the focus of the investigation, with which Cyberonics has said it is cooperating, it is believed to center on the actions of FDA and the company during the device approval process. Following announcement of FDA's decision to approve the VNS device for TRD, a spokesperson for the finance committee said that its investigation was still open.