Device Dossier
Octrode Lead Kits - Implantable lumbar neuromuscular electrical stimulation system lead
Device Dossier for Octrode Lead Kits - Implantable lumbar neuromuscular electrical stimulation system lead (Implantable lumbar neuromuscular electrical…
Intended purpose
The percutaneous leads are intended to be used with Abbott Medical neurostimulation systems by connecting to a compatible pulse generator, either directly or with a compatible lead extension. Indications for Use: This neurostimulation system is indicated as an aid in the management of chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome and intractable low back and leg pain.
Functional description
SCS uses low-intensity electrical impulses to stimulate nerve fibres within the spinal cord, often inhibiting chronic pain messages from reaching the brain. The leads are designed for introduction into the epidural space. The lead assembly consists of 8 cylindrical electrodes spaced at precise intervals. Kit contains a guide wire, tunnelling tool, lead anchor, epidural needle, lead introducer and stylet.