Yesterday, medical device company NeuroMetrix announced that it has filed a 501(k), also known as a premarket notification, with the Food and Drug Administration for its SENSUS Pain Therapy device. SENSUS is a non-invasive transcutaneous electrical nerve stimulator that is used for pain management and relief. The system is designed to treat chronic intractable pain, such as that associated with diabetic neuropathy.
Painful diabetic neuropathy affects as many as 10-20% of people with diabetes, and is a serious and disabling complication of diabetic peripheral neuropathy (DPN). The pain is typically managed pharmacologically; however, many patients remain undertreated. Recent evidence based reviews have suggested that transcutaneous electrical nerve stimulators may be useful in managing painful diabetic neuropathy.
SENSUS employs the same nerve stimulation technology as the company’s NC-stat® DPNCheck™ device and includes advanced features that may address the technical and clinical limitations of existing nerve stimulators. The device’s technology also can maximize patient compliance, one of the fundamental challenges with pain therapy.
Shai N. Gozani, M.D., Ph.D., President and CEO of NeuroMetrix, remarked, “The filing of a 510(k) for SENSUS represents a key milestone in this product development program. We look forward to feedback from the FDA and working towards a timely clearance. Once commercialized, we believe that SENSUS will complement NC-stat DPNCheck, our sural nerve conduction test for DPN, and move us towards our goal of creating a unique and valuable diabetic neuropathy product portfolio and franchise.”
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