StimRouter Neuromodulation System Receives CE Mark for Overactive Bladder Treatment

Bioness, Inc., leading provider of advanced and clinically supported medical devices for the treatment of chronic peripheral nerve pain, announced that its neuromodulation system StimRouter has been CE marked for the treatment of overactive bladder (HAV) in Europe. The StimRouter has already been CE marked in February 2014 for the treatment of chronic pain from the peripheral nerves and as a complement to other non-drug treatment options. The system is now a viable option for clinicians looking to help their patients with overactive bladder. Right now, Bioness is recruiting patients for an FDA (US Food and Drug Administration) FDA study to encourage use of the system for treating HAV in the United States. HAV affects approximately 546 million people worldwide and can dramatically affect the quality of life, causing effects ranging from discomfort to professional and social isolation. The overactive bladder may also cause involuntary loss of urine (incontinence). Current HAV treatments include frequent and external percutaneous needle stimulation procedures performed in the clinician’s office, and more invasive systems of nerve stimulation that involve the placement of a probe and a generator impulses in the patient.

The StimRouter is able to respond to a significant unmet medical need for people living with overactive bladder. It can be a permanent solution, including the placement of a small 15 cm insulated wire and a wearable patch on the implant that feeds the device and allows patients to control their symptoms by sending them gentle stimulating pulses to the tibial nerve to reduce the chronic need to urinate. The patient can take care of his personalized treatment without having to go to the doctor’s office. “Using neuromodulation to treat overactive bladder resolves the fundamental latent problem of disrupted messages between the nervous system and the bladder. Sacral neuromodulation has been around for some time, but the arrival of minimally invasive tibial nerve stimulation is a leap forward in treating patients,” said Dr. Howard Goldman, principal investigator of the IDE study on the StimRouter for the treatment of HAV in the United States, Cleveland, Ohio. “The implantable probe in the tibial nerve allows a minimally invasive placement of the probe, which then gives the patient the opportunity to manage his own treatment at home. This combination of ease of implementation and treatment should revolutionize the treatment of overactive bladder.”

The StimRouter was the first FDA-approved, mini-invasive, long-term neuromodulation medical device indicated for chronic pain from peripheral nerves. When patients undergo the StimRouter implantation procedure, they only need a small incision and the procedure is often performed in just 30 minutes, under local anesthesia. A manual remote control allows patients to control their pain by emitting gentle stimulating impulses that scramble signals before they reach the brain. “The StimRouter has already helped patients in the US, Europe and Canada manage their chronic pain and move forward and can now improve the quality of life for hyperactive patients in Europe.” bladder (HAV),” says Todd Cushman, President and CEO of Bioness. “Overactive bladder can cause effects that range from discomfort to isolation at work and from activities of daily living. The StimRouter is able to respond to a significant unmet medical need by offering a unique solution that allows the patient to take charge of their personalized treatment without having to make many doctor visits.” – Medical Buyer Bureau