Bioness StimRouter® Neuromodulation System Receives CE Approval for Overactive Bladder (OAB) Treatment

Monday, February 18, 2019

Bioness, Inc., the leading provider of advanced, clinically-supported medical devices for the treatment of chronic peripheral nerve pain, today announced that its StimRouter® neuromodulation system is CE approved for the treatment of overactive bladder (OAB) across Europe. The StimRouter received the CE mark in February 2014 for the treatment of chronic peripheral nerve pain and as a supplement to other non-drug therapies. The system is now a viable option for physicians who want to help their patients who live with OAB. Currently, Bioness is recruiting patients for a US FDA IDE trial to use the system to treat OAB in the US to support.

OAB affects approximately 546 million people worldwide  and can have a dramatic impact on the quality of life, with effects ranging from embarrassment to the isolation of work and social life. An overactive bladder  can also lead to involuntary loss of urine (incontinence). Current treatment methods for OAB include frequent externalized percutaneous needle stimulation procedures performed in the doctor's office and more invasive systems for stimulating sacral nerves using a lead and pulse generator in the patient.

The StimRouter has the potential to meet a significant unmet medical need for people with OAB as a permanent solution. It incorporates an implant of a small, 15 cm long insulated wire and a portable patch over the implant that drives the device and allows the patient to control his symptoms by delivering gentle stimulation pulses to the tibial nerve, thus reducing chronic urinary urgency , This gives the patient control over his or her individual therapy without having to go to the doctor.

"Neuromodulation to treat the overactive bladder addresses the fundamental problem of impaired communication between the nervous system and the bladder, sacral neuromodulation has been used for some time, but the introduction of minimally invasive splint nerve stimulation represents a quantum leap in the treatment of patients," said Dr. Howard Goldman , principal examiner of the StimRouter OAB IDE study in Cleveland , Ohio. "The implantable tibial nerve electrode cable allows for minimally invasive placement of the cable, followed by self-treatment of the patient at home, and this combination of ease of placement and treatment should revolutionize overactive bladder therapy."

The StimRouter was the first FDA-approved, minimally-invasive, long-term neuromodulation medicine product used to treat chronic peripheral nerve pain. StimRouter implantation requires a small incision and is often performed in local anesthesia in just 30 minutes. A portable remote control allows patients to control their pain by delivering gentle stimulation pulses to disrupt signals before they reach the brain.

"The StimRouter has helped patients in the US , Europe and Canada control their chronic pain and can now improve the quality of life for patients in Europe who suffer from overactive bladder (OAB)," said Todd Cushman , President and CEO of Bioness . "The impact of OAB can lead to embarrassment and isolation from the work and activities of daily life.The StimRouter has the potential to provide a unique unmet medical need for a significant unmet medical need by giving the patient control over their individual therapy without having to go to the doctor.