The only FDA-approved restorative treatment for CLBP in its class
ReActiv8® is an implantable neurostimulation system for mechanical CLBP and multifidus muscle dysfunction. 77% of patients in a three-year trial experienced CLBP relief and 67% of patients experienced resolution.
What is REACTIV8® and
does it work?
ReActiv8® Restorative Neurostimulation is a restorative therapy designed to address impaired neuromuscular control and degeneration of the multifidus muscle linked to mechanical chronic low back pain (CLBP).
ReActiv8® works by targeting the multifidus muscle with electrical pulses delivered through proprietary self-anchoring lead technology placed adjacent to the medial branch of the dorsal ramus.
An effective, long-term solution
78% of patients reported they were ‘definitely satisfied’ with their treatment with ReActiv8®. In our clinical trial, 76% of patients had improvements of ≥ 50% in VAS and/or ≥20 points in ODI. ReActiv8® offers reprise for patients that are plagued with chronic lower back pain and gives them renewed hope with a sustainable, pragmatic, and long-term solution.
Who’s it for?
|Adults with Chronic Lower Back Pain (CLBP)|
|Patients with no neuropathic or radicular pain|
|No prior spinal surgeries|
|Inadequate or temporary relief from traditional treatment methods|
|Adults with mild lower back pain|
|Patients with radicular pain|
|Patients who have had prior spinal surgery or implants|
|Long-term relief from traditional methods|
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 important safety and product information, visit www.mainstaymedical.com.