Group Asks FDA to Reject Cyberonics Device
Cyberonics' request to market an implantable nerve stimulator for treating chronic depression should be rejected by U.S. authorities, consumer group Public Citizen said.
In a letter to the FDA, the group said Cyberonics had not proved the device was effective or safe for depressed patients. The company's studies provided little evidence that the device helped relieve chronic depression, Public Citizen said. Plus, concerns about worsening depression, suicide attempts and sudden deaths in the trials have not been fully investigated, the group said.
The Cyberonics product, known as the VNS Therapy System, is an implantable stopwatch-size device that sends electrical pulses to the vagus nerve in the neck. The product is approved for helping to control epileptic seizures, and Cyberonics is seeking permission to market it for cases of depression that persist despite therapy with antidepressant drugs. Cyberonics has said it expects full approval this month.