The U.S. Food and Drug Administration (FDA) has cleared StimRouter, an implantable neuromodulation device designed to treat chronic, intractable pain of peripheral nerve origin from.
The device was developed by Bioness, a manufacturer of unique innovative systems for rehabilitation of impairments resulting from central nervous system disorders. The StimRouter is the only implanted device to be cleared by the FDA with a specific indication for peripheral nerve stimulation.
Bioness founder Alfred Mann said that 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.
"The device represents a less invasive and more cost-effective treatment method when compared to commercially available pain management implanted devices," Mann said.
Bioness President and CEO Todd Cushman said that the FDA clearance of StimRouter represents a monumental development for Bioness.
"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 (SCS) and opiates," Cushman said.