product approval introduction

Bioness StimRouter Cleared in Europe to Treat Fecal Incontinence

Bioness, a Valencia, California firm, won European regulatory approval for its StimRouter neuromodulation system to treat fecal incontinence.  Previously cleared in the EU as a tool for managing chronic pain and overactive bladder, the new indication significantly expands the stated capabilities of this novel neuromodulation system. For the management of fecal incontinence, the StimRouter system targets the tibial nerve near the ankle. This is achieved thanks to a tiny implant and an external pulse transmitter patch that’s stuck to the skin over where the electronic lead implant is positioned. The entire outpatient procedure takes about thirty minutes to complete and relies on local anesthesia. Read more.

Source: Medgadget, January 8, 2020