Ed Kensik10.19.06
The FDA has postponed a panel meeting to review a device that could potentially compete with Cyberonics’ Vagus Nerve stimulator, the only device on the market to treat major depression, according to the Associated Press.
The agency postponed a scheduled October 31 meeting at which a panel of outside experts was expected to vote on the safety and efficacy of Neuronetics’ Neurostart system. Neuoronetics is a privately held medical device company based in Malvern, PA.
Agency officials declined to comment on the reasons for the postponement or when a new meeting date would be announced.
Cyberonics of Houston, TX is a manufacturer of medical devices using vagus nerve stimulation for the long-term treatment of epilepsy and other chronic neurological disorders. The stimulation process is delivered by the company’s VNS Therapy System product, an implantable generator similar to a cardiac pacemaker.
The Neurostar system uses magnetic pulses targeted at specific areas of a patient's brain to relieve major depression, according to Neuronetics. The company says its device differs from Cyberonics because it is not surgically implanted. Instead, doctors treat patients with the device in the office over the course of three to six weeks.
Last year Cyberonics’ device became the first to receive FDA approval to treat depressed patients who do not respond to drug treatment. The pacemaker-like device is implanted in the chest and stimulates nerves in the neck to alleviate severe depression symptoms.
The agency postponed a scheduled October 31 meeting at which a panel of outside experts was expected to vote on the safety and efficacy of Neuronetics’ Neurostart system. Neuoronetics is a privately held medical device company based in Malvern, PA.
Agency officials declined to comment on the reasons for the postponement or when a new meeting date would be announced.
Cyberonics of Houston, TX is a manufacturer of medical devices using vagus nerve stimulation for the long-term treatment of epilepsy and other chronic neurological disorders. The stimulation process is delivered by the company’s VNS Therapy System product, an implantable generator similar to a cardiac pacemaker.
The Neurostar system uses magnetic pulses targeted at specific areas of a patient's brain to relieve major depression, according to Neuronetics. The company says its device differs from Cyberonics because it is not surgically implanted. Instead, doctors treat patients with the device in the office over the course of three to six weeks.
Last year Cyberonics’ device became the first to receive FDA approval to treat depressed patients who do not respond to drug treatment. The pacemaker-like device is implanted in the chest and stimulates nerves in the neck to alleviate severe depression symptoms.