Implantable Neuromodulation Device Cleared

The FDA has cleared an implantable neuromodulation device (StimRouter, Bioness) designed to treat chronic, intractable pain of peripheral nerve origin, according to a Bioness press release.

Bioness founder Alfred Mann said in the release, “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.” 

The device consists of an implanted lead, external pulse transmitter (EPT) and conductive electrode, controlled by a small hand-held wireless control unit. 

Electrical signals are transmitted transdermally from the EPT through the electrode, down the lead to the origin of pain. Each system is programmed at the direction of the physician to meet the requirements of the patient.