Bioness Announces Preliminary European Post-Approval Results of StimRouter® Neuromodulation System for the Treatment of Overactive Bladder at the 49th International Continence Society Annual Meeting
StimRouter helping improve lives of patients in Europe and Australia beyond the management of chronic pain
Valencia, California – September 4, 2019 – Bioness, Inc., the leading provider of advanced, clinically supported medical devices for the treatment of chronic pain of peripheral nerve origin, is attending the 49th International Continence Society (ICS) Annual Meeting in Gothenburg, Sweden from 3-6 September 2019. Bioness is exhibiting at booth 5A to discuss the StimRouter® Neuromodulation System’s success with Overactive Bladder (OAB) and the device’s effectiveness in treating chronic pelvic pain in Europe, Australia, and the United States.
Overactive bladder affects approximately 546 million people worldwide and may lead to the involuntary loss of urine (incontinence). Unlike traditional treatments such as invasive sacral nerve stimulation systems and externalized percutaneous needle stimulation procedures requiring frequent clinic visits, StimRouter provides patients with a minimally invasive, permanent treatment that puts the patient in control of their therapy. Aachen University Hospital is the first hospital in Europe that is implanting the StimRouter for the treatment for OAB.
“As we look to better serve our patients, we’re constantly evaluating new procedures and innovations. We are excited to be using the StimRouter and very encouraged by the initial outcomes. With further clinical trials and evaluation being conducted in Europe and America, this procedure has the potential to dramatically impact our patients’ lives,” said Dr. Sajjad Rahnama’i, Aachen University Hospital.
The StimRouter is the first FDA-cleared, minimally-invasive, long-term neuromodulation medical device indicated to treat chronic pain of a peripheral nerve origin. Following the StimRouter receiving 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, in February 2019 the StimRouter received CE Mark Approval for the treatment of Overactive Bladder (OAB) across Europe.
Relying on gentle stimulating pulses that disrupt nerve signals before they reach the brain, the system is a viable option to clinicians who are looking to help their patients who are living with OAB. Bioness is currently in the middle of an FDA investigational device exemption (IDE), multicenter study in the US and Canada to receive FDA approval for the OAB application for StimRouter.
“With the CE Mark approval for treatment of OAB earlier this year, the StimRouter has been able to improve quality of life for patients in Europe that are suffering from overactive bladder,” says Todd Cushman, President and CEO at Bioness. “Since OAB can affect a person’s daily life significantly, we’re excited to see the success clinicians are having in treating not only their patient’s OAB, but also their chronic pelvic pain. We’re hopeful we will receive approval in the US for this application to help a broader range of patients who are suffering from this isolating condition.”
For more information on using the StimRouter to treat OAB, stop by Bioness’ booth 5A and receive a free gift at ICS 2019 or 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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