VALENCIA, Calif., Jan. 6, 2020 /PRNewswire/ -- Bioness, Inc., the leading provider of advanced, clinically supported medical devices for the treatment of chronic pain of peripheral nerve origin, today announced its StimRouter® Neuromodulation System has received CE Mark Approval for the treatment of fecal incontinence (FI) across Europe. Previously approved to treat chronic pain and Overactive Bladder (OAB), physicians in Europe will now be able to treat patients with fecal incontinence by targeting the Tibial Nerve, located near the ankle with a small implant.
The inability for patients to control their bowels can directly impact social interaction and general quality of life. This untreated and often under-managed population is often confronted with depression, low self-esteem, and antisocial behavior due to fear and embarrassment. It is estimated that fecal incontinence impacts approximately 18% of the general population. Often viewed as a taboo subject, people may be embarrassed to discuss their experience with FI with healthcare professionals or their friends and family.
"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. "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 StimRouter previously received CE Mark approval in February 2014 for the treatment of chronic pain of peripheral nerve origin as an adjunct to other non-drug therapeutic options, and again in February 2019 for the treatment of Overactive Bladder (OAB). When patients undergo the StimRouter implant procedure, it requires one incision and is often completed in 30 minutes using only local anesthesia. A small, hand-held remote allows the patient to wirelessly control and customize their therapy.
"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," shared Todd Cushman, President and CEO at Bioness. "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."
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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