ReActiv8 Implantable Pulse Generator - Analgesic spinal cord electrical stimulation system pulse generator implantable

Intended purpose

A sterile, implantable, electronic component of an implantable lumbar neuromuscular electrical stimulation system (Reactiv8) intended to deliver episodic electrical stimulation to nerves that innervate lumbar muscles to elicit contraction for the treatment of chronic low back pain. 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 pulse generator with integrated battery that when connected to two implantable stimulation leads may be programmed to deliver stimulation. The generator is communicated with via either a patient controlled activator or a technician controlled programmer WAND.