Device Dossier

Artisan MRI 2x8 Surgical Lead Kit - Stimulator, electrical, analgesic, spinal cord

Device Dossier for Artisan MRI 2x8 Surgical Lead Kit - Stimulator, electrical, analgesic, spinal cord (Stimulator, electrical, analgesic, spinal cord,…

Intended purpose

The surgical paddle leads function as a component of Boston Scientific’s Spinal Cord Stimulation systems by delivering electrical stimulation to the nerve structures in the dorsal aspect of the spinal cord, resulting in an inhibition of pain sensation.

Functional description

The distal (paddle) end of the lead has two columns of eight evenly spaced planar electrodes. On the proximal side, this lead employs 2 lead tails. The end of each tail has eight evenly spaced contacts. The right tail of the paddle lead is laser-etched to allow for ease of right and left identification. Each tail can be inserted into an IPG, or into a lead extension. The device is MRI conditional.

TGA Public Summary