FDA clears Bioness StimRouter neuromodulation system

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Bioness has announced that the US Food and Drug Administration (FDA) has cleared the StimRouter, an implantable neuromodulation device designed to treat chronic, intractable pain of peripheral nerve origin.

“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.”

A minimally invasive implantable device designed to reduce pain by specifically targeting the affected peripheral nerve, Bioness believes that the StimRouter is 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.”

Bioness president and chief executive officer Todd Cushman commented that, “The StimRouter builds on the success of our external neuromodulation systems and allows us to expand into the pain management market as well as other future applications. The positive clinical results, ease of use and a specific indication for use that targets peripheral nerve pain, make the StimRouter a unique and compelling alternative to spinal cord stimulation and opiates.”