Post regulatory approval, Toronto-based patients now utilizing device for management of chronic pain
VALENCIA, Calif., June 11, 2018 /PRNewswire/ -- Bioness, Inc., the leading provider of cutting edge, clinically supported neuromodulation therapies, today announced the first successful implants of its StimRouter® Neuromodulation System for the treatment of chronic pain at Women's College Hospital in Toronto, Canada. Following approval by Health Canada in January, the peripheral nerve stimulation device is now available in Canada, the United States and Europe, giving patients a non-opioid, permanent solution for the treatment of chronic pain of a peripheral nerve origin, excluding pain in the craniofacial region.
"Significant advances in the miniaturization and durability of neuromodulation devices have provided interventional pain physicians with the right tools, like the StimRouter PNS System, to treat chronic pain related to nerve injuries, trauma, stroke and other irreversible damages with a simple, minimally invasive procedure. Effective PNS may help reduce or even discontinue opioids that are commonly prescribed for these patients," said Dr. Michael Gofeld, pain physician at Women's College Hospital and first to implant the StimRouter in Canada.
"The approval of StimRouter in Canada is a tremendous step forward as we expand our non-drug solution to chronic pain of a peripheral nerve origin with a robust, validated, treatment for people seeking pain relief," said Todd Cushman, President and CEO of Bioness. "It is our hope that the StimRouter will offer reduced pain and increased activity for patients and an answer for doctors facing the serious realities of the opioid epidemic. We believe this step forward in Canada indicates the conversation on pain is shifting in the right direction toward simple, reversible, permanent solutions."
StimRouter is the first minimally-invasive, long-term neuromodulation medical device cleared and available in the United States, Europe, and Canada. The patient controlled medical device is an adjunct to other modes of therapy and is being well received by patients and clinicians alike. To date, more than 20 nerve locations have been targeted on many hundreds of patients worldwide, signaling the broad utility and effectiveness of this technology.
About the StimRouter™ Neuromodulation System The StimRouter™ Neuromodulation System is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy (e.g., medications). The StimRouter is not intended to treat 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. Precautions, Warnings and Contraindications can be found at www.StimRouter.com.
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 solution. 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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StimRouter® and Bioness® are trademarks of Bioness, Inc. | www.bioness.com | 800.211.9136 | Rx Only | Additional information about StimRouter can be found at www.stimrouter.com