ReActiv8® Restorative Neurostimulation
For chronic mechanical low back pain caused by multifidus muscle dysfunction
When your back's stabilizing muscle stops working
The multifidus is the largest stabilizing muscle of the lower spine. When injury or long-standing pain disrupts the nerve signals that control it, a condition called multifidus dysfunction, the spine loses its dynamic support. The joints and discs then take on uncontrolled loading, which can cause chronic mechanical low back pain.
Unlike treatments that block or mask pain signals, ReActiv8 is designed to restore the brain's control of the multifidus, addressing a cause of the pain rather than only the symptoms.
Does this sound familiar?
Pain from multifidus dysfunction often follows a recognizable pattern:
How ReActiv8 works
ReActiv8 is a small generator implanted under the skin during a minimally invasive outpatient procedure. Two thin leads are positioned to stimulate the nerves that control the multifidus on each side of the spine.
You run therapy yourself in two 30-minute sessions a day, which many patients describe as feeling like a deep tissue massage. Over time, the stimulation helps re-engage the muscle so it can stabilize the spine again. The system is full-body MRI conditional.
In long-term clinical study results, 8 out of 10 patients reported substantial (more than 50%) improvement in pain and/or function, and 9 out of 10 were “definitely satisfied” with ReActiv8.1
Individual results vary.
Learn about multifidus dysfunction
Your path to relief
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Evaluation
We review your history, exam, and imaging to confirm multifidus dysfunction and make sure medications and physical therapy have been tried.
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Implant
The generator and leads are placed in a minimally invasive outpatient procedure, and you go home the same day.
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Daily therapy
After healing, you start twice-daily 30-minute sessions with a handheld remote.
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Follow-up
We track your progress over the following months. Improvement is typically gradual as muscle control returns.
Is ReActiv8 right for you?
ReActiv8 may be an option if:
- Your pain is mostly in your lower back, rather than down your legs
- You have chronic mechanical low back pain that hasn't improved with pain medications and physical therapy
- You are not a candidate for spine surgery
Our physicians will review your symptoms, exam, and imaging to determine whether this treatment is a good fit for you.
Important safety information
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.
As with any implanted device, risks include infection, bleeding, pain at the implant site, lead movement, and the possibility of additional surgery to revise or remove the system. Your physician will review the risks with you.
For important safety and product information, visit mainstaymedical.com/safety. Rx only.
1Gilligan C, et al. Five-year longitudinal follow-up of restorative neurostimulation shows durability of effectiveness in patients with refractory chronic low back pain associated with multifidus muscle dysfunction. Neuromodulation. 2024.
ReActiv8 and Restorative Neurostimulation are trademarks of Mainstay Medical. Images and video courtesy of Mainstay Medical.