The US Food and Drug Administration (FDA) has granted 510(k) clearance for Bioness’ StimRouter, an implantable neuromodulation device, designed to treat chronic, intractable pain of peripheral nerve origin.
StimRouter is claimed to be the only implanted device to get FDA clearance with a specific indication for peripheral nerve stimulation.
The minimally invasive neuromodulation medical device StimRouter includes an implanted lead, external pulse transmitter (EPT) and conductive electrode, controlled by a small handheld wireless control unit.
Bioness founder Alfred Mann said: "The StimRouter is a disruptive technology that presents an opportunity to change the way healthcare professionals treat chronic peripheral pain by targeting and neuromodulating the affected nerve.
"Furthermore, the StimRouter represents a less invasive and more cost-effective treatment method when compared to commercially available pain management implanted devices."
Approximately 50 million people suffer from chronic pain, costing the US healthcare system $150bn annually.
StimRouter is designed to be a cost-effective alternative to injections, ongoing medication regiments and complex surgeries.
Bioness president Todd Cushman said: "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, make the StimRouter a unique and compelling alternative to spinal cord stimulation (SCS) and opiates."
The company said electrical signals are transmitted transdermally from the EPT through the electrode, down the lead to the origin of pain.
In order to meet the requirements of the patient, each system is programmed at the direction of the physician.
Bioness offers neurological solutions for people suffering from hand and lower extremity paralysis, including the L300 Foot Drop System, L300 Plus System and the H200 Wireless Hand Rehabilitation System, which use functional electrical stimulation (FES).