Mainstay Medical

USA Indications for Use: The ReActiv8 System is an implantable neurostimulation system that employs a restorative therapy designed to restore muscle control of the lumbar spine for improved low back pain management. More specifically, ReActiv8 is indicated for bilateral stimulation of the L2 medial branch of the dorsal ramus as it crosses the transverse process at L3 as an aid in the management of intractable chronic low back pain associated with multifidus muscle dysfunction, as evidenced by imaging or physiological testing in adults who (i) have failed therapy including pain medications and physical therapy and (ii) are not candidates for spine surgery. ReActiv8 is a prescription device implanted by certified physicians in an outpatient setting. Patients should talk to their health care provider to discuss whether ReActiv8 is right for them. For clarification and details on symbols used, visit https://mainstaymedical.com/symbols. For important safety and product information, visit mainstaymedical.com/safety.

EU Intended Purpose/Indications for Use: Intended Purpose/Indications for Use: ReActiv8 is an adjunct to medical management of Chronic Low Back Pain for relief of pain in adults who have attempted at least medical management and physical therapy.

Australia Intended Purpose/Indications for Use: The ReActiv8 Implantable Pulse Generator device is indicated as an aid in the management of intractable chronic low back pain associated with multifidus muscle dysfunction, as evidenced by imaging or physiological testing. The device is intended for patients that have attempted medical management and at least one course of physical therapy. For important safety and product information, visit https://fixmylowerback.com.au/safety/patient-safety-australia. 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.