First Electronic Device for Opioid Withdrawal Therapy Approved by FDA The FDA has given a regulatory green light to the First Device that reduces Opioid Withdrawal symptoms. The NSS-2 Bridge from Innovative Health Solutions, a Versailles, Indiana firm, is stuck to the skin behind the ear and relies on four electrodes that are attached around the ear. The electrodes are used to deliver electric current to a set of occipital and cranial nerves (V, VII, IX, and X), hopefully helping addicts to avoid agitation, insomnia, and other symptoms of kicking opioids. The same Device was Approved by the FDA three years ago for use in acupuncture and the current approval went under the*de novo review process intended for uniquely new low to moderate risk technologies.
The FDA based its decision on a study involving 73 patients that were experiencing physical symptoms of withdrawal. Before using the NSS-2 Bridge, the subjects had an average*clinical opiate Withdrawal scale (COWS) score of 20.1 (the higher, the worse the symptoms). Using the device, the subjects had a reduction in the COWS score by at least 31% within a half hour of Therapy activation. Moreover, 64 out of the 73 patients switched to medication assisted Therapy after five days of using the NSS-2 Bridge.
The Device requires a prescription and is not intended to be used by patients using pacemakers or that are suffering from hemophilia or psoriasis.
11-16-2017, 08:09 AM
First Electronic Device for Opioid Withdrawal Therapy Approved by FDA
The FDA has given a regulatory green light to the First Device that reduces Opioid Withdrawal symptoms. The NSS-2 Bridge from Innovative Health Solutions, a Versailles, Indiana firm, is stuck to the skin behind the ear and relies on four electrodes that are attached around the ear. The electrodes are used to deliver electric current to a set of occipital and cranial nerves (V, VII, IX, and X), hopefully helping addicts to avoid agitation, insomnia, and other symptoms of kicking opioids. The same Device was Approved by the FDA three years ago for use in acupuncture and the current approval went under the*de novo review process intended for uniquely new low to moderate risk technologies.
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