The Morph Device. Therapeutic Neuromodulation Systems, LLC, a US-based sales & marketing organization, announces the US Food and Drug Administration (FDA) has granted 510(k) clearance for the Morph Device, a percutaneous nerve field stimulatory system (PNFS) with an indication for use as an aid in the reduction of symptoms related to opioid withdrawal.
The Morph is a physician applied, peripheral nerve stimulator which consists of a battery-powered externally affixed generator, 3 wire leads attached to 3 electrode/ needle arrays. These leads are inserted into the left ear, controlling 85% of the brain's ability to transmit pain symptoms. The Morph Device is a small electrical nerve stimulator placed behind the patient’s ear and can be used as an aid to reduce the symptoms of opioid withdrawal, through application to branches of Cranial Nerves V, VII, IX and X, and the occipital nerves.
The arrays are designed to produce a field effect similar to surgically implanted peripheral neurostimulators. The electrode/needle arrays are implanted according to the individual’s arterial and cranial nerve anatomy. The exact location of the implantation is determined by both knowledge of auricular neuroanatomy and visualization of the neurovascular bundles.
These locations have been well tested and documented in the Auriculotherapy Manual, historically evolved in China over 5000 years. The 2nd edition was published on January 1, 1996, and the 4th edition in 2014 by Terry Oleson, Ph.D.
Given the FEAR & PAIN of withdrawal was cited in a March 2018 Industry Survey as the most significant barrier keeping patients from treatment, our mission is to remove the FEAR & PAIN to dramatically increase treatment participation.
“The Morph Device is effective for treating the acute pain occurring from opioid withdrawal. It is not a cure for addiction. Evidence of its method of action can be found in addiction medicine textbooks.
The electrical stimulation enhances the release of neuropeptides, primarily beta-endorphin and enkephalins in the central nervous system. These neuropeptides then bind to the vacant mu and delta receptors thereby alleviating the symptoms of physical withdrawal. The morph device is used to detoxify opioid dependent without the patient experiencing the discomfort of withdrawal symptoms.” Dr. Bryant George, MD
Introducing The Morph Device from The Morph Device on Vimeo.
