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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.

1) Patients should consult their healthcare professional to determine if the ReActiv8 Implantable Pulse Generator (IPG) device is right for them; and 2) Outcomes may vary for each patient. Patients should consult their healthcare professional about factors that could impact the level and timing of the effect; and 3) Patients must talk to their health professional about whether the ReActiv8 IPG device may be suitable as part of the overall plan to manage intractable chronic mechanical lower back pain; and 4) The ReActiv8 IPG device is not a first-line treatment for chronic mechanical lower back pain; and 5) Surgery is required in order to use the ReActiv8 IPG device and any surgical procedure carries risk

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