Bioness StimRouter Gains CE Mark to Treat Fecal Incontinence

Bioness, Inc., a provider of advanced, clinically supported medical devices for the treatment of chronic pain of peripheral nerve origin, today announced its StimRouter Neuromodulation System has received CE mark approval for the treatment of fecal incontinence (FI) across Europe. Previously approved to treat chronic pain and Overactive Bladder (OAB), physicians in Europe will now be able to treat patients with fecal incontinence by targeting the Tibial Nerve, located near the ankle with a small implant.
 
The inability for patients to control their bowels can directly impact social interaction and general quality of life. This untreated and often under-managed population is often confronted with depression, low self-esteem, and antisocial behavior due to fear and embarrassment. It is estimated that fecal incontinence impacts approximately 18 percent of the general population. Often viewed as a taboo subject, people may be embarrassed to discuss their experience with FI with healthcare professionals or their friends and family.
 
“The StimRouter for fecal incontinence is a minimally invasive, relatively easy implant that places the lead electrodes next to the Nervus Tibialis,” said Dr. Concha Perez, 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 QoL with a more than 90% event free life.”
 
The StimRouter previously received CE mark approval in February 2014 for the treatment of chronic pain of peripheral nerve origin as an adjunct to other non-drug therapeutic options, and again in February 2019 for the treatment of Overactive Bladder (OAB). When patients undergo the StimRouter implant procedure, it requires one incision and is often completed in 30 minutes using only local anesthesia. A small, hand-held remote allows the patient to wirelessly control and customize their therapy.
 
“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,” shared Todd Cushman, President and CEO at Bioness. “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.”