Bioness secures CE Mark approval for StimRouter system

US-based medical technology company Bioness has secured CE Mark approval for its StimRouter neuromodulation system to treat faecal incontinence.

The small implantable system treats faecal incontinence by targeting the tibial nerve near the ankle.

The minimally invasive neuromodulation medical device includes an implanted lead, external pulse transmitter (EPT) and conductive electrode, controlled by a small handheld wireless control unit.

Electrical signals transmit transdermally from the EPT through the electrode, down the lead to the origin of pain.

The StimRouter implantation procedure requires one incision, often completed within half an hour.

Approximately 18% of the population is impacted by faecal incontinence, which affects social interaction and quality of life.

Bioness president and CEO Todd Cushman said:  “The StimRouter is changing the lives of patients who are looking for new ways to treat not just their pain but also life-impacting conditions, such as faecal incontinence and overactive bladder.

“The expanded regulatory clearance and clinical understanding of stimulating peripheral nerves is allowing for innovative uses of the StimRouter device in Europe, as well as potentially expanding its use in the United States beyond our current chronic pain indication in the future.”

In 2015, the US Food and Drug Administration (FDA) granted 510(k) clearance for Bioness’ StimRouter to treat chronic peripheral pain.

Furthermore, in early 2019, Bioness’ StimRouter secured CE Mark for the treatment of overactive bladder.