News Release Details
Bioventus Receives 510(k) Clearance for StimRouter Pain Management Device
Industry Leading Peripheral Nerve Stimulator Upgraded to Improve Patient User Experience with Control of their Unique Chronic Pain Condition, Longer Battery Life
DURHAM, N.C., March 01, 2022 (GLOBE NEWSWIRE) -- Bioventus Inc. (Nasdaq: BVS) (“Bioventus” or the “Company”), a global leader in innovations for active healing, announced that the US Food and Drug Administration (FDA) has awarded 510(k) clearance to the next generation StimRouter® Neuromodulation System for the treatment of chronic pain of peripheral nerve origin, excluding craniofacial pain. StimRouter is a minimally invasive neuromodulation medical device consisting of a thin, implanted lead with conductive electrode, external electric field conductor (E-EFC), and StimRouter Plus Mobile Application. Electrical signals are transmitted transcutaneously from the E-EFC and conducted to the target nerve by the implanted lead.
Thousands of patients have successfully used the StimRouter Neuromodulation system, and the newly cleared StimRouter system provides the same clinically proven, long-term pain relief while significantly improving the patient’s control and user experience. The next generation system includes a smartphone application and a new state of the art external electric field conductor, allowing patients greater freedom to return to active lives.
“The impact of chronic, debilitating pain is more than just managing the impacted anatomy, it is also about helping return the individual back to a life pre-pain,” said John Nosenzo, Chief Commercial Officer, Bioventus. “The emotional and psychological damage from living with pain is horrific and we are pleased to support all the physicians who are committed to improving patient lives, in particular with alternatives to opioids when possible. The next generation StimRouter will support patients and physicians to meet their pain treatment goals as the previous generation of peripheral nerve stimulation has done for many years.”
Every day, individuals attempt to live their lives while suffering from debilitating pain that prevents each from working, enjoying their personal time and maintaining relationships with family and friends. Respecting the long-term and potentially negative consequences of opioids, patients have successfully undergone the minimally invasive StimRouter implant procedure and are now living a productive and comfortable life. Peripheral nerve stimulation (PNS) is the future of pain management. With over 50 million Americans living with daily chronic pain, PNS technology provides a focal, non-opioid treatment option and adoption is growing rapidly amongst clinicians and patients due to PNS’ proven effectiveness at reducing chronic pain.
The upgraded StimRouter technology and associated mobile application will help improve the experiences of patients who find pain relief through this innovative technology.
Bioventus delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. The Innovations for Active Healing from Bioventus include offerings for pain treatment, restorative therapies and surgical solutions. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide. For more information, visit www.bioventus.com, and follow the Company on LinkedIn and Twitter. Bioventus and the Bioventus logo are registered trademarks of Bioventus LLC. Bioventus and the Bioventus logo are registered trademarks of Bioventus LLC. StimRouter, Bioness, are trademarks of Bioness Inc.
Individual results may vary. Patients are advised to consult with a qualified healthcare professional to determine if this product is right for them. Important Safety Information and Risks: For Indications for Use, Warnings, Precautions, and other safety information please refer to www.stimrouter.com/safety-information/.
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