BioNess’ Neuromodulation System Cleared in Europe for Fecal Incontinence

BioNess’ StimRouter neuromodulation device has earned the CE Mark for treating fecal incontinence.

The StimRouter consists of a small implanted wire that targets the tibial nerve near the ankle, enabling patients to  control their symptoms through gentle stimulating pulses. A hand-held remote allows patients to wirelessly control their therapy.

The device previously received CE Mark in 2014 for the treatment of chronic pain of peripheral nerve origin as an adjunct to other non-drug therapies, and again in  2019 for the treatment of overactive bladder.