BioNess announced today that it won CE Mark approval for its StimRouter neuromodulation system indicated for the treatment of fecal incontinence.

The StimRouter system previously won approval for treating chronic pain and overactive bladder. The small implantable system targets the tibial nerve near the ankle.

Patients undergoing the StimRouter implant procedure receive one incision as the procedure is often completed in 30 minutes using only local anesthesia. A hand-held remote is designed to allow the patient to wirelessly control and customize therapy.

Valencia, Calif.–based BioNess’ platform won CE Mark in February 2014 for treating chronic pain of the peripheral nerve origin, then again in February 2019 for the overactive bladder. The system was launched in Canada in June 2018 and the company launched a patient registry for the platform in January 2019.

“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 fecal incontinence and overactive bladder,” BioNess president & CEO Todd Cushman said in a news release. “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.”

“The StimRouter for fecal incontinence is a minimally invasive, relatively easy implant that places the lead electrodes next to the nervus tibialis,” added Dr. Concha Perez of the Hospital Universitario de la Princesa, Madrid. “The patient we implanted, referred from Dr. Cecilio Santander, a gastroenterologist, shows an important, significant improvement in the patient’s [quality of life] with a more than 90% event-free life.”