The US Food and Drug Administration (FDA) has cleared a noninvasive neuromodulation device (Stimpod NMS460, Xavant Technology) for the relief of chronic intractable pain, the company has announced.
"We are thrilled at the news that our revolutionary device can now be used in the US," Corlius Birkill, CEO, Xavant Technology, said in a press release.
"This ground-breaking technology has the ability to help tens if not hundreds of millions of people just in the US as a valuable treatment asset for neurologists, chiropractors, acupuncturists, physical therapists, physiatrists, and medical pain practitioners."
The device applies a unique, patented pulsed radiofrequency (PRF) waveform to the affected area transcutaneously.
This waveform creates electromagnetic effects similar to invasive PRF treatments. Several case studies have shown instant and dramatic relief of chronic intractable pain, said the press release.
The Stimpod NMS460 also incorporates nerve-locating technology. Its "stimulation probe" is designed to direct the current to a particular nerve or region, such as a joint or muscle. It enables practitioners to evaluate the treatment progress of damaged nerves.
The STIMPOD NMS460 waveform provides all the generally accepted advantages of a normal transcutaneous electrical nerve stimulation device, with the added advantageous of PRF, "all in one waveform delivered to the patient in a non-invasive manner," the company said on its website.
The device is focused on the symptomatic relief and management of chronic intractable pain, as well as adjunctive treatment in the management of postsurgical pain and posttraumatic acute pain problems, and as an adjunct for pain control due to rehabilitation.
The need for this device is "profound," said the press release. More than 100 million Americans report that they have a problem with pain.
Chronic pain is characterized by neuroplastic changes that cause sensitization of the nervous system. These changes, according to background information provided by the company, result in anatomic and physiologic changes that affect neurologic function, which may cause other changes that allow the pain to continue with or without further peripheral input, and a lower pain threshold. This dysfunction accounts for the epiphenomena associated with the disease, including emotional, memory, and motor changes, which then becomes the illness of chronic pain.
Treatment of chronic pain costs an estimated $600 billion annually in the United States. The current standard of care for chronic pain includes "drug cocktails," such as corticosteroids, opiate pain relievers, and injections combined with treatments like physical therapy and counseling. Treatments can come with various short-term and long-term side effects.
In addition to being noninvasive and non–drug-related, the Stimpod NMS460 has "zero side effects" and "a fast onset of effect at a fraction of the cost of comparable treatments," said the press release.
Xavant Technology is a leading supplier of nerve stimulators for regional and general anesthesia applications.
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Cite this: FDA Clears Noninvasive Device for Intractable Pain - Medscape - Aug 01, 2017.