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www.fdanews.com/articles/84671-cyberonics-responds-harshly-to-senate-committee-report

CYBERONICS RESPONDS HARSHLY TO SENATE COMMITTEE REPORT

February 17, 2006

Cyberonics, maker of the Vagus Nerve Simulation (VNS) Therapy system for treatment-resistant depression (TRD), criticized a report from the Senate Finance Committee that questioned whether the device met the usual FDA criteria for safety and effectiveness.

The report issued by Committee Chairman Charles Grassley (R-Iowa) expressed concern that the device was approved over objections from FDA staff scientists. But Cyberonics said the committee issued its report without interviewing world-renowned experts on treatment-resistant depression.

"VNS Therapy is the only safe and effective treatment option ever specifically developed, studied, FDA-approved and fully-informatively labeled for the treatment of chronic or recurrent treatment-resistant depression; the most unrelenting, disabling, life-threatening and expensive form of depression," said Robert Cummins, Cyberonic's CEO.

"Unfortunately for the large number of Americans and their families who are trying to live with TRD and their psychiatrists who are trying to help them, the Senate Finance Committee [Feb. 16] issued a report without having interviewed world-renowned experts on TRD, widely published biostatisticians, patients and families living with TRD, patient advocacy organizations like NAMI, VNS Therapy TRD study investigators, and all the FDA statisticians and clinicians involved in the review of the submissions, that ultimately led to the approval of the only FDA-approved treatment option for TRD," Cummins added.