Bioness, a Valencia, California firm, won European regulatory approval for its StimRouter neuromodulation system to treat fecal incontinence.
Previously cleared in the EU as a tool for managing chronic pain and overactive bladder, the new indication significantly expands the stated capabilities of this novel neuromodulation system.
For the management of fecal incontinence, the StimRouter system targets the tibial nerve near the ankle. This is achieved thanks to a tiny implant and an external pulse transmitter patch that’s stuck to the skin over where the electronic lead implant is positioned. The entire outpatient procedure takes about thirty minutes to complete and relies on local anesthesia.
“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, in a Bioness press release. “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 patient is sent home with a remote control that allows for adjustments to the amount of neuromodulation that is administered by the StimRouter. This allows the physician to program the device, but the patient to still have control over the needed stimulation levels.
Check out our in-depth coverage of the experience from the first StimRouter implants in patients in Canada.
Flashbacks: StimRouter Receives Health Canada Approval: Interview with Mark Geiger of Bioness; Experiences from the First StimRouter Implanted in Patients in Canada; Bioness StimRouter Minimally Invasive Peripheral Nerve Stimulation System
Product page: StimRouter