Bioness is a Valencia, California medical device/rehabilitation company founded by the late Alfred Mann some 15 years ago. He had previously acquired a miniature stimulator called the BION, and a company called NESS who had a footdrop stimulator. The combination of the two is where the name Bioness came from.
One of its products is the “StimRouter”, which is an externally-powered implantable peripheral nerve stimulator designed to reduce chronic pain. It gained FDA approval in 2015 and was launched in mid-2016.
Unlike most externally-powered neurostimulators however, the StimRouter is not powered by RF received from the external transmitter. Instead, the external pulse transmitter is more like a TENS unit with gelled electrodes applied to the skin. The implant has no electronic components. It is just a lead that has a coil electrode that intercepts part of the current between the TENS electrodes, and routes the captured current to small electrodes in contact with the target nerve at the distal end of the lead.
Bioness StimRouter System consists of
- An implantable multi-electrode lead with integrated receiver in loader.
- Surgical tools for implantation of the implantable lead.
- An external programming system with a clinician programmer and charger, an external pulse transmitter tester and accessories.
- A patient-operated system with an external pulse transmitter (StimRouter EPT), disposable StimRouter Electrodes, an external patient programmer and charger, and accessories.
According to Bioness:
“The receiver end of the StimRouter Lead captures a portion of the signal generated by the StimRouter EPT and emitted by the surface gel pads on the StimRouter Electrode. The receiver end of the StimRouter Lead has one receiver electrode, which is manufactured by coiling the wire on the outside of the silicone tubing at the end of the lead. The conductive surface of the receiver end is in contact with the surrounding tissue.
The stimulation end of the StimRouter Lead delivers the current received from the receiver end of the lead to the target stimulation point. The stimulation end of the lead has three electrodes, which are manufactured by coiling the wire on the outside of the silicone tubing at the end of the lead. The conductive surface of the stimulation end is in contact with the surrounding tissue. Each electrode measures 1 mm in length and is spaced 1 mm from the adjacent electrode. The silicone anchor of the StimRouter Lead secures the lead in the tissue. This four- pronged anchor placed toward the distal end of the lead, just proximal to the stimulation electrodes, ensures proper lead release from the insertion tools and is designed to reduce lead migration after implantation.”
The webpage for the StimRouter is at: http://stimrouter.com/