The FDA has granted market clearance for Bioness' Stimrouter for the treatment of chronic peripheral pain.
The company describes StimRouter as a minimally invasive, implanted neuromodulation device that sends electrical signals to the pain's point of origin. The device is controlled by a wireless, hand-held unit.
"The FDA clearance of StimRouter represents a monumental development for Bioness. The StimRouter builds on the success of our external neuromodulation systems and allows us to expand into the pain management market as well as other future applications. The positive clinical results, ease of use and a specific indication for use that targets peripheral nerve pain makes the StimRouter a unique and compelling alternative to Spinal Cord Stimulation (SCS) and opiates," said Bioness CEO Todd Cushman, in a release.
According to Bioness, an estimated 50 million people in the U.S. suffer from chronic pain.