RESEARCH TRIANGLE PARK – Durham-based Bioventus has received an OK from the U.S. Food and Drug Administration to market its next-generation pain treatment device.
The global orthobiologics company has been granted 510(k) clearance for the newest edition of its StimRouter Neuromodulation System to treat chronic peripheral nerve pain. A 501(k) is a premarket submission to show that a medical device is safe, effective and substantially equivalent to a product already on the market.
Bioventus said the StimRouter is a minimally invasive device consisting of a thin, implanted lead with a conductive electrode, external electric field conductor (E-EFC) and mobile application. It works by transmitting electrical signals transcutaneously (through the skin) from the E-EFC that are guided to the targeted nerve by the implanted lead.
The newest version of the StimRouter system provides the same clinically proven long-term pain relief, while also significantly improving patients’ control of their medical conditions and the overall user experience, according to the company. The system includes a smartphone application and an upgraded external electric field conductor.
“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 Bioventus Chief Commercial Officer John Nosenzo. “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 patients’ lives, in particular with alternatives to opioids when possible.”
With over 50 million Americans living with daily chronic pain, peripheral nerve stimulation like that provided by the StimRouter – which targets the nerves that transmit pain signals to the brain – is growing rapidly as an effective and non-opioid treatment option, Bioventus said.
The company – established in 2012 – was formerly the biologics and clinical therapies division of Smith and Nephew, a publicly traded medial equipment manufacturing corporation based in the United Kingdom.
Bioventus has more than 1,160 employees globally. In addition to its Durham headquarters, the company has offices in Memphis; Valencia, California; Farmingdale, N.Y.; and Mississauga, Ontario, Canada, and a manufacturing location in Hod Hasharon, Israel. Its international headquarters are in Hoofddorp, The Netherlands.
Bioventus said its products will help more than 600,000 people regain active lifestyles this year. The company operates in more than 50 countries around the globe.
(C) N.C. Biotech Center