Device Dossier
Evoke CAP12 Trial Percutaneous Lead Kit - Implantable lumbar neuromuscular electrical stimulation system lead
Device Dossier for Evoke CAP12 Trial Percutaneous Lead Kit - Implantable lumbar neuromuscular electrical stimulation system lead (Implantable lumbar…
Intended purpose
The Evoke System is a spinal cord stimulation (SCS) system which stimulates the nerves in the spinal cord, measures their responses and automatically adjusts the stimulation level accordingly. It is intended to aid in the management of chronic intractable pain of the lower back and/or legs. The Evoke CAP12 Trial Percutaneous Lead is a 12 electrode lead intended to be placed in the epidural space overlying the spinal cord. The Evoke CAP12 Trial Percutaneous Lead is connected to an external stimulator during the Evoke System trial period.
Functional description
The Evoke CAP12 Trial Percutaneous Lead delivers electrical stimulation to neural tissue. It has 12 electrodes located near the distal end of each lead. The proximal end of the lead connects to a lead extension or external spinal cord stimulator.