Bioness StimRouter® Neuromodulation System Receives CE Mark Approval for the Treatment of Overactive Bladder (OAB)
StimRouter now available in Europe beyond the management of chronic pain
Valencia, California – February 18, 2019 – Bioness, Inc., the leading provider of advanced, clinically supported medical devices for the treatment of chronic pain of peripheral nerve origin, announced today its StimRouter® Neuromodulation System has received CE Mark Approval for the treatment of Overactive Bladder (OAB) across Europe. The StimRouter previously received CE Mark in February 2014 for the treatment of chronic pain of peripheral nerve origin and as an adjunct to other non-drug therapeutic options. The system will now be a viable option to clinicians who are looking to help their patients who are living with OAB and will be available to patients beginning February 12, 2019. At this time, Bioness is enrolling patients for a U.S. FDA IDE study to support the use of the system for the treatment of OAB in the U.S.
OAB affects approximately 546 million people worldwide and can have a dramatic impact on quality of life with effects ranging from embarrassment to isolation from work and social life. Overactive Bladder may also lead to the involuntary loss of urine (incontinence). Current treatments for OAB include frequent, externalized percutaneous needle stimulation procedures in the clinician’s office and more invasive sacral nerve stimulation systems that involve placement of a lead and pulse generator into the patient.
The StimRouter has the potential to meet a significant unmet medical need for people who are living with OAB as a permanent solution that includes the implant of a small, 15cm insulated wire, and a wearable patch over the implant that powers the device and allows patients to control their symptoms by delivering gentle stimulating pulses to the Tibial Nerve to reduce the chronic urge to urinate. This puts the patient in charge of their customized therapy without having to travel to the doctor’s office.
“Neuromodulation to treat overactive bladder deals with the underlying fundamental problem of impaired messaging between the nervous system and bladder. Sacral Neuromodulation has been utilized for some time but the advent of minimally invasive tibial nerve stimulation represents a quantum leap in the treatment of patients,” said Dr. Howard Goldman, Principal Investigator of the StimRouter OAB IDE study in the U.S., Cleveland, Ohio. “The implantable tibial nerve lead affords for minimally invasive placement of the lead with subsequent patient self-treatment at home. This combination of ease of placement and treatment should revolutionize the treatment of overactive bladder.”
The StimRouter was the first FDA-cleared, minimally-invasive, long-term neuromodulation medical device indicated to treat chronic pain of a peripheral nerve origin. When patients undergo the StimRouter implant procedure, it requires one small incision and is often completed in just 30 minutes using local anesthesia. A hand-held remote allows patients to control their pain by delivering gentle stimulating pulses to disrupt signals before they reach the brain.
“The StimRouter has been helping patients in the US, Europe, and Canada manage their chronic pain to move forward with their lives and can now improve quality of life for patients in Europe that suffer from overactive bladder (OAB),” says Todd Cushman, President and CEO at Bioness. “The effects of OAB can cause embarrassment and isolation from work and activities of daily living. The StimRouter has the potential to meet a significant unmet medical need with a unique solution by putting the patient in charge of their customized therapy without having to travel to the doctor’s office for multiple visits.”
For more information about the StimRouter, visit www.stimrouter.com.
About StimRouter® Neuromodulation System
StimRouter is approved by the FDA to treat chronic pain of peripheral nerve origin, excluding pain in the craniofacial region. StimRouter is a minimally invasive neuromodulation medical device consisting of a thin, implanted lead with conductive electrode, external pulse transmitter (EPT), and hand-held wireless patient programmer. Electrical signals are transmitted transdermally from the EPT through the electrode, down the lead to the target nerve.
StimRouter is programmed at the direction of the physician to meet patient requirements but is controlled by the patient to address the patients’ specific, changing pain management needs
About Bioness Inc.
Bioness is the leading provider of innovative technologies helping people regain mobility and independence. Bioness solutions include implantable and external neuromodulation systems, robotic systems, and software based therapy programs providing functional and therapeutic benefits for individuals affected by pain, central nervous system disorders, and orthopedic injuries. Currently, Bioness offers six medical devices within its commercial portfolio which are distributed and sold on five continents and in over 25 countries worldwide. Our technologies have been implemented in the most prestigious and well-respected institutions around the globe with approximately 90% of the top rehabilitation hospitals in the United States currently using one or more Bioness solutions. Bioness has a singular focus on aiding large, underserved customer groups with innovative, evidence-based solutions and we will continue to develop and make commercially available new products that address the growing and changing needs of our customers. Individual results vary. Consult with a qualified physician to determine if this product is right for you. Contraindications, adverse reactions and precautions are available online at www.bioness.com.
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