Neuromodulator to treat bladder wins CE mark

April 9, 2019 0 By FM

StimRouter Neuromodulation System developed by Bioness has received CE Mark Approval in Europe for the treatment of overactive bladder (OAB).

In the US, the StimRouter currently has FDA approval for the treatment of chronic pain of a peripheral nerve origin as an adjunct to other non-drug therapeutic options.

Bioness is, currently, enrolling patients for a US FDA IDE study to support the use of the system for the treatment of OAB in the US.

Unlike traditional treatments that include invasive sacral nerve stimulation systems and externalized percutaneous needle stimulation procedures requiring frequent clinic visits, the StimRouter provides patients with a minimally invasive, permanent treatment that puts the patient in control of their therapy at home.

The StimRouter procedure requires only one small incision and is completed in about 30 minutes while the patient is awake under local anaesthesia. A hand-held remote allows patients to control their symptoms by delivering gentle stimulating pulses to the tibial nerve to reduce the chronic urge to urinate.