People suffering from chronic pain in the lower legs and feet will soon have a new device available for purchase without a prescription thanks to the new regulatory clearance from the FDA. Developed by NeuroMetrix, a Waltham, Massachusetts firm, the device is a transcutaneous electrical nerve stimulator (TENS), the technology within which has already been prescribed in the form of the SENSUS Pain Management System for people with diabetic peripheral neuropathy and others with chronic pain in the legs and feet.
The SENSUS is strapped around the leg just below the knee and pressing a button on top of the unit is all it takes to activate it. The device has a 60 minute run cycle and pain relief often continues to last long past the treatment session. For those needing constant therapy, the device can be used in “continuous ” mode so that sessions automatically kick in every other hour, allowing a full hour in between for the legs to get some rest from the stimulation. The unit can be worn during sleep and two can be used at the same time for pain management in both legs.
Update: This article was changed to reflect the fact that it is not the SENSUS device itself that received FDA approval
From the SENSUS product page:
Benefits
- Fast acting, on-demand chronic pain relief option
- Easy to learn, easy to use and convenient for patients
- Non-narcotic, non-addictive, no side effects
- Low profile, wearable technology keeps patients active during the day and may improve their quality of sleep at night – SENSUS is the only transcutaneous electrical nerve stimulator that is FDA cleared for use during sleep
Why It Is Unique
SENSUS incorporates technological advances over traditional TENS devices:
- Preconfigured electrode for ease, accuracy of placement and patient mobility
- One button control for ease of use
- Automatic determination of therapeutic intensity to optimize therapeutic benefit and simplify usage for patients
- Higher stimulation voltage and current to overcome high-impedance and nerve degeneration due to neuropathy
- Only transcutaneous electrical nerve stimulator that is FDA cleared for use during sleep
Flashbacks: Q&A With NeuroMetrix CEO Shai N. Gozani, M.D., Ph.D…; SENSUS Transcutaneous Pain Management System Approved for Use During Sleep…; NeuroMetrix Sensus Diabetic Pain Management System…
Product page: SENSUS Pain Management System…
Press release: FDA Clears NeuroMetrix Wearable Technology for Over-the-Counter Use in Treatment of Chronic Pain
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