Jason Lawton07.20.05
The FDA has finally approved Cyberonic’s Vagus Nerve Stimulation (VNS) Therapy System for treating patients with chronic depression, a reversal of an earlier decision. The decision comes after the agency went against the recommendation of one of its physician panels last year and denied the Houston-based company from marketing the device for depression treatment.
The device, specifically aimed at patients with treatment-resistant depression (TRD), is considered the first of its kind. The VNS Therapy is delivered from a small, pacemaker-like generator implanted in the chest that sends preprogrammed, intermittent, mild electrical pulses through the vagus nerve in the neck to the brain.
“Today for the first time, Americans with treatment-resistant depression have an FDA-approved, informatively labeled, long-term treatment option for their lifelong and life-threatening illness,” said Cyberonics CEO Robert P. “Skip” Cummins about the device, which was approved by the FDA in 1997 to treat medically refractory epilepsy. Europe and Canada had approved the device for depression treatment in 2001.
In June of last year, a physician panel recommended the device for market approval, but the agency ignored the recommendation and rejected the VNS therapy two months later.
The device, specifically aimed at patients with treatment-resistant depression (TRD), is considered the first of its kind. The VNS Therapy is delivered from a small, pacemaker-like generator implanted in the chest that sends preprogrammed, intermittent, mild electrical pulses through the vagus nerve in the neck to the brain.
“Today for the first time, Americans with treatment-resistant depression have an FDA-approved, informatively labeled, long-term treatment option for their lifelong and life-threatening illness,” said Cyberonics CEO Robert P. “Skip” Cummins about the device, which was approved by the FDA in 1997 to treat medically refractory epilepsy. Europe and Canada had approved the device for depression treatment in 2001.
In June of last year, a physician panel recommended the device for market approval, but the agency ignored the recommendation and rejected the VNS therapy two months later.