Device Dossier

Infinion 16 Contact Trial Lead Kit - Electrode/lead, stimulator, implantable, neurological

Device Dossier for Infinion 16 Contact Trial Lead Kit - Electrode/lead, stimulator, implantable, neurological (Neural-tissue electrical stimulation lead,…

Intended purpose

The Infinion 16 Lead Trial Kit is used with the Precision SCS system as an aid in the management of chronic intractable pain by delivering electrical stimulation to the nerve structures in the dorsal aspect of the spinal cord, resulting in an inhibition of pain sensation. It is intended to be used for the temporary trial phase.

Functional description

The Infinion 16 Trial Lead Kit consists of the lead which has 16 contacts located near the distal end. Each contact is 3mm in length and is spaced 1mm for the adjacent contact. The kit also contains suture sleeves, insertion needle, steering cap and lead position labels.

TGA Public Summary