Pain Relief Device Now Approved For Overnight Use
Waltham-based medical device company NeuroMetrix has created the SENSUS Pain Management System, a non-invasive device designed to deliver pain relief to chronic pain and diabetes patients, which has now been approved by the FDA for overnight use.
The SENSUS Pain Management System device is a small, lightweight device that can be worn on one or both legs to relieve chronic pain as a result of painful diabetic neuropathy (PDN). At the press of a button, the device sends a stimulation to non-painful nerves. This stimulation helps to decrease pain by changing the level of certain pain-related chemicals in the brain. The device is an easy, non-narcotic way to relieve pain in diabetes patients with chronic pain.
SENSUS is unobtrusive enough to be worn while still remaining active during the day, and has now been approved by the FDA to be worn while sleeping. About half of patients diagnosed with painful diabetic neuropathy experience sleep disturbances, in the form of pain in their legs and feet, which can aggravate their condition.
Usually, the FDA requires that devices such as SENSUS carry a label discouraging use during sleep due to the danger of possible electrical hazards. NeuroMetrix has solved this problem by developing an electrode peeling detection algorithm to prevent such dangerous electrical issues and in doing so, has made SENSUS available for patients who experience painful sleep disturbances.
Dr. Shai N. Gozani, President and CEO of NeuroMetrix said in a press release:
“SENSUS is the first and only transcutaneous electrical nerve stimulator that specifically includes use during sleep within its 510(k) indications,” he said.