VALENCIA, Calif.--(BUSINESS WIRE)--Bioness, Inc. announced today that the first commercial procedure of StimRouter™ Neuromodulation System has been performed under the company’s FDA clearance to treat chronic, intractable pain of peripheral nerve origin as an adjunct to other modes of therapy. StimRouter is the only implantable neuromodulation device indicated and marketed to treat chronic pain of peripheral nerve origin.
“StimRouter is an exciting and novel technology which has the potential to benefit many thousands of patients with chronic pain. The product is extremely versatile, minimally invasive and will expand the use of neuromodulation outside traditional patient populations,” said Nagy Mekhail, MD, PhD, who performed the procedure at the Cleveland Clinic.
With chronic pain affecting, and often debilitating, an estimated 50 million people and contributing $150 billion in annual costs to the U.S. healthcare system, there has never been a greater need for innovative pain management options. StimRouter is designed to reduce pain by specifically targeting the affected peripheral nerve. As a potential cost-effective alternative to injections, ongoing medication regimens and complex surgeries, StimRouter will enable underserved patient populations to access neuromodulation technology to treat chronic pain.
“We are motivated to expand the frontier of neuromodulation and change the status quo,” stated Todd Cushman, President and CEO of Bioness. “The Bioness Team is focused on expanding StimRouter accessibility through a methodical clinical training program with special focus on our principal commercial markets.”
About StimRouter™ Neuromodulation System
StimRouter is cleared by the FDA to treat chronic pain of peripheral nerve origin. StimRouter is a minimally invasive neuromodulation medical device consisting of an implanted lead, external pulse transmitter (EPT) and conductive electrode, controlled by a small, 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.
About Bioness Inc.
Bioness is the leading provider of innovative technologies helping people regain mobility and independence. Bioness solutions include external and implantable functional electrical stimulation (FES) 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. 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.
StimRouter™ and Bioness® are trademarks of Bioness
Inc. | www.bioness.com
| Rx Only
Additional information about StimRouter can be found at www.stimrouter.com.
