FDA Clears Bioness StimRouter to Treat Chronic Peripheral Pain
Chronic pain patients will soon have a new option to help them find relief now that the US Food and Drug Administration has approved the StimRouter, from Valencia, Calif-based Bioness. According to a statement from Bioness, the implantable device is designed to treat chronic, intractable pain of peripheral nerve origin.
The StimRouter is engineered to offer minimally invasive treatment, and works to reduce pain by zeroing in on the affected peripheral nerve. According to Bioness, the device may provide an alternative to complex surgeries, ongoing medication regimens, and injections that is cost-effective.
Bioness further describes the StimRouter as a neuromodulation devices that consists of an implanted lead, external pulse transmitter (EPT), and conductive electrode. The device is operated by a wireless control unit designed to be small enough to be held in the user’s hand. Electrical signals move transdermally through the electrode to reach the origin of pain.
The StimRouter reportedly is programmed at the direction of the physician to meet the patient’s requirements.
In a media release from Bioness company founder Alfred Mann, he described the StimRouter as a “disruptive technology” that would be significant because of how it can target and neuromodulate an affected nerve.
“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,” says Bioness President and CEO Todd Cushman.