US health officials approved on Friday an implantable electronic device designed to help treat severe depression in patients who have failed to respond to all other treatments.
Houston-based Cyberonics said the Food and Drug Administration had signed off on its Vagus Nerve Stimulation Therapy System. The pacemaker-like device sends electrical impulses to the brain, which can apparently result in improvement in those suffering from severe depression. The system was originally designed to treat epilepsy, according to MarketWatch.
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The FDA approved the VNS system with the caveat that it be used with more traditional psychiatric therapies. The device costs about $15 000 (R100 000), MarketWatch said.
The system has already been approved to treat depression by regulators in Europe and Canada.
Critics said there has been a lack of rigorous scientific research to prove the VNS system really works, according to the Associated Press.
But FDA medical device chief Dr Daniel Schultz said he was persuaded by Cyberonics' research, despite initial scepticism within his agency. "These are patients pretty much at the end of the line in terms of what treatment options are available to them," he said. – (HealthDayNews)
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