StimRouter is a minimally invasive neuromodulation medical device can be controlled by the patients to address their changing pain management needs
Bioness secures CE Mark Approval for StimRouter Neuromodulation System (Credit: Pixabay/JimCoote.)
Bioness has secured CE Mark Approval of StimRouter Neuromodulation System for the treatment of fecal incontinence (FI) across Europe.
StimRouter was previously received CE Mark approval in February 2014, for chronic pain of peripheral nerve origin, and for the treatment of Overactive Bladder (OAB) in in February 2019.
In addition, the CE Mark approval allows its StimRouter to treat patients in Europe with faecal incontinence, by targeting the Tibial Nerve using a small implant.
Hospital Universitario de la Princesa doctor Concha Perez said: “The StimRouter for fecal incontinence is a minimally invasive, relatively easy implant that places the lead electrodes next to the Nervus Tibialis.
“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.”
StimRouter can be controlled by the patients according to their pain management needs
Bioness has developed StimRouter as a minimally invasive neuromodulation medical device, comprising a thin implanted lead with a conductive electrode, external pulse transmitter (EPT), and hand-held wireless patient programmer.
The device has been designed to transmit the electrical signals transdermally from the EPT through the electrode, down the lead to the target nerve.
In addition, the device can be programmed as per the physician’s directions to meet patient requirements, and can also be controlled by the patients according to their changing pain management needs.
The implant procedure requires only one incision using local anaesthesia and takes only 30 minutes, and patient can wirelessly control and customize their therapy using a small, hand-held remote.
Bioness president and CEO Todd Cushman said: “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.
“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.”