Therapeutic Neuromodulation Systems Announces: FDA Clears the Morph Device and Grants Indication for Use as an Aid for Opioid Withdrawal
On May 2nd, 2018, the US Food and Drug Administration (FDA) granted a 510(k) clearance for the Morph Device, with an indication for use as an aid in the treatment of opioid withdrawal. The announcement was made by Therapeutic Neuromodulation Systems, LLC, a US-based sales and marketing organization with a mission to encourage and increase treatment participation by removing the fear and pain associated with opioid withdrawal.
The Morph Device is a percutaneous nerve field stimulatory system (PNFS), designed to promote mobility and ensure the comfort of patients. The device’s auricular neurostimulator produces electrical pulses which flow to ear-fitted needles. According to Bryant George Sr., MD, the electrical stimulation enhances the production of neuropeptides, primarily beta- endorphin and enkephalins in the central nervous system. These neuropeptides then bind to the vacant mu and delta receptors thereby substantially reducing the discomfort of withdrawal symptoms.
The Morph can last for a maximum of 10 days, and its power can be increased or decreased like regular medication dosage, depending on the intensity of the withdrawal symptoms experienced by the patient.
The device can also be tested while still on the patient’s ear to ensure that it’s functioning properly.
It is helpful to note that The Morph is a physician-directed device, and as such, cannot be made available directly to the public. The device is contraindicated for use by patients with cardiac pacemakers, hemophilia, and psoriasis vulgaris.
For more information, please contact:
Neal M. Brown