Device Dossier

Evoke 12C Trial Percutaneous Lead Kit - Implantable lumbar neuromuscular electrical stimulation system lead

Device Dossier for Evoke 12C 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 12C Trial Percutaneous Lead is a 12 electrode lead intended to be placed in the epidural space overlying the spinal cord. The Evoke 12C Trial Percutaneous Lead is connected to an external stimulator during the Evoke System trial period.

Functional description

The Evoke 12C 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.

TGA Public Summary