Submitted by kBLASTER Team on
by Fort Mill Times
VALENCIA, CALIF. — Bioness, Inc. announced that the U.S. Food and Drug Administration (FDA) has 510(k) cleared the StimRouter®, an implantable neuromodulation device designed to treat chronic, intractable pain of peripheral nerve origin. The StimRouter is the only implanted device to be cleared by the FDA with a specific indication for peripheral nerve stimulation.
With an estimated 50 million people suffering from chronic pain and burdening the U.S. healthcare system with $150 billion in annual costs, there’s never been a greater need for innovative pain management options. As a minimally invasive implantable device designed to reduce pain by specifically targeting the affected peripheral nerve, the StimRouter is designed to be a cost-effective alternative to injections, ongoing medication regiments, and complex surgeries.
According to Bioness founder Alfred Mann, “The StimRouter is a disruptive technology that presents an opportunity to change the way healthcare professionals treat chronic peripheral pain by targeting and neuromodulating the affected nerve. Furthermore, the StimRouter represents a less invasive and more cost-effective treatment method when compared to commercially available pain management implanted devices.”
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