Valencia-based Bioness, Inc., the leading provider of advanced, clinically supported medical devices for the treatment of chronic pain of peripheral nerve origin, has launched the first and only Patient Registry for peripheral nerve stimulation (PNS) using its StimRouter Neuromodulation System.
The launch of the StimRouter Registry demonstrates Bioness’ commitment to collecting long-term, robust clinical data that helps educate clinicians to further understand how the StimRouter, a non-opioid, minimally invasive, permanent pain management technology, can be applied across the human body.
Physicians and government agencies within the U.S. are beginning to recognize the value of non-opioid treatments for chronic pain with the Joint Commission’s new pain management standards directing healthcare organizations to develop pain treatment strategies to include non-opioid approaches. Many clinicians are already offering non-opioid treatments—such as the StimRouter—to patients who have chronic pain due to stroke, accident, or injury. Bioness’ leadership in understanding these patient populations will continue through its StimRouter Patient Registry and synthesizing PNS outcomes to guide future treatment by clinicians. Beginning in Q1 2019, patients will be able to opt-in to the registry.
“The StimRouter™ Registry is part of a comprehensive initiative to study and develop clinical data relative to peripheral nerve stimulation,” said Eric Grigsby, MD, MBA, and Chief Medical Officer at Bioness. “We strongly believe that PNS will play a critical role in the management of chronic pain of peripheral nerve origin.”
The StimRouter was launched in 2016 and is the first neuromodulation device specifically designed to treat chronic peripheral nerve pain. It has been implanted in over 1,000 chronic pain patients at more than 80 leading medical organizations across the country. In addition, the platform technology built into StimRouter is being investigated for additional uses beyond chronic pain.
“As the first PNS product approved for commercial use, Bioness was very deliberate about the StimRouter™ launch to demonstrate safety and efficacy. The Registry is one more piece of our clinical study strategy to deliver robust, prospective clinical data to help define where PNS is best utilized and what we can learn to continue to launch new products that meet unmet medical needs in the neuromodulation market,” said Todd Cushman, President and CEO at Bioness.
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.