FDA Delays Meeting on Depression Device (Vns Message Board)

Title: FDA Delays Meeting on Depression Device

Birdbomb - October 19, 2006 07:26 PM (GMT)

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FDA Delays Meeting on Depression Device

© 2006 The Associated Press

WASHINGTON — The Food and Drug Administration 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.

The agency announced Thursday it has postponed a scheduled Oct. 31 meeting at which a panel of outside experts was expected to vote on the safety and efficacy of privately held Neuronetics' Neurostar system.

Agency officials declined to comment on the reasons for the postponement or when a new meeting date would be announced.

A company representative contacted for this story could not immediately provide any additional information.

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.

labrat - October 31, 2006 06:37 PM (GMT)

Is this device supposed to achieve what ECT is suppoded to, without the memory loss? Does anybody know if you are TRD how it will differ from ECT in effectiveness? If you are TRD the ECT only work for a short term.

Just curious. :wavetowel2:

:im_033: Labrat :im_033:

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