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Diabetics faced with chronic pain are often left with the decision to either medicate or live with it.
But a drug-free pain management system might be an alternative, which can decrease pain through nerve stimulation.
We talked with Dr. Shai Gozani, Chief Executive Officer and Director of NeuroMetrix, about the SENSUS Pain Management System.
IAD: Tell me about SENSUS.
Dr. Gozani: The SENSUS Pain Management System is a transcutaneous electrical nerve stimulator (TENS) uniquely designed for people with diabetes and chronic pain. It is a device that is worn on one or both legs and is activated by simply pressing a button. SENSUS provides pain relief by comfortably stimulating the nerves that carry normal, non-painful sensations to the brain. Stimulation of these nerves changes the levels of certain natural chemicals in the nervous system that decrease pain. The SENSUS device is used with a disposable snap-in electrode that is changed every two weeks. The device is configured to the patients unique physiology through a simple procedure that takes a couple of minutes. Thereafter, an hour-long therapy session is initiated at the push of a single button. The device is powered by a rechargeable lithium ion battery.
What mechanisms enable it to be safe for overnight use?
SENSUS is the only TENS device cleared by the U.S. Food and Drug Administration for use during sleep. If the SENSUS electrode, which is the interface or buffer between the device and the skin, becomes dislodged for any reason, the device immediately shuts off.
How does it help treat foot ulcers?
SENSUS is designed for chronic intractable pain. It does not address treatment of foot ulcers.
How has the device been tested?
SENSUS falls into the category of transcutaneous electrical nerve stimulators or "TENS." There have been multiple independent clinical studies involving TENS devices over the years. On the NeuroMetrix website, there is a monograph summarizing the benefits of TENS devices from nine clinical studies. In addition, NeuroMetrix has performed numerous tests of SENSUS during the product development period and after market launch. We are developing plans for new clinical studies that would be initiated in 2014.
Is the device recommended as a replacement for narcotic medication?
It has been prescribed both as a complement to pain medications and also as an alternative to pain medications.
Are there any long-term risks associated with use?
SENSUS is non-addictive, non-narcotic. It has no side effects.
For more about the SENSUS system, visit www.neurometrix.com.
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