ReActiv8 Percutaneous Lead - Implantable lumbar neuromuscular electrical stimulation system lead

Intended purpose

A sterile, implantable, conductive wire component of an implantable lumbar neuromuscular electrical stimulation system (Reactiv8) intended to deliver episodic electrical stimulation to nerves that innervate lumbar muscles when connected to a ReActiv8 Implantable Pulse Generator. The ReActiv8 System is indicated for bilateral stimulation of the L2 medial branch of the dorsal ramus as it crosses the L3 transverse process as an aid in the management of intractable chronic low back pain associated with multifidus muscle dysfunction, as evidenced by imaging and associated physiological presentation.

Functional description

A stimulation lead that when connected to an implantable pulse generator is capable of delivering pulsed stimulation to the lumbar muscle region. The lead is held in position via tines which are deployed upon surgical placement.