FDA Approves ReActiv8

In June 2020, The U.S. Federal Drug Administration approved an implantable neurostimulation device known as the ReActiv8.  The device is used to treat low back pain caused by dysfunction of the paraspinal muscles. The ReActiv8 is surgically implanted in the lumbar region in order to electronically stimulate a key nerve that is responsible for contracting a stabilizing lumbar muscle.

The ReActiv8 is marketed as an option for patients whose attempts at conservative treatment, including medications and physical therapy, have failed, yet are not candidates for spinal fusion or laminectomy type surgeries.  After implantation of the device, the muscle stimulations are activated by the patient two times per day via remote control.   

Two hundred patients participated in a randomized clinical trial of the device prior to receiving FDA approval. The study was conducted by the device's manufacturer, Mainstay Medical.  Results of the clinical trial found that ReActiv8 can, in some patients, provide progressive improvement in disability and pain over time.  

A study of the same device that was published in 2018 defined a successful outcome as subjective pain levels having diminished by at least two points on the 1-10 pain scale.  Improvement of subjective pain by at least two points on the pain scale was considered clinically meaningful.  In the 2018 study, 63% of patients achieved such improvement after 90 days of use.  The numbers decreased a bit over time. Some improvements in disability index scores were also recorded.  The same study reported no serious unanticipated adverse events by the end of the one-year study period. However, five participants had the device removed, most due to reports of no improvement.

Some adverse events related to the procedure in a study of 53 subjects included:

• Procedure-related:  wound pain, inflammation, hematoma or post-op discomfort
• Device related: loss of stimulation, discomfort at pocket/lead
• Device/Procedure-related: inflammation due to lead incision, post-op nervous system irritation
• Stimulation related: muscle fatigue, undesired sensations
• Devise/stimulation related: undesired sensations

The costs associated with the ReActiv8 device and the implantation surgery are substantial.  The device will, in most cases, not last a lifetime and will have to be replaced or removed, which requires subsequent surgery.  The device has a battery with a limited life.  The cost of the device is likely on par with a spinal cord stimulator, the implantation of which is valued at approximately $33,000 for Medicare patients.  Blue Cross/Blue Shield values a spinal cord stimulator implant procedure at nearly $58,000. Those figures include physician charges, surgical facility fees, and cost of equipment.  There is also a range of annual maintenance costs associated with the device.

Due to its high costs, a patient who has not achieved sufficient low back pain relief with medications or physical therapy may want to try one of the cheaper over-the-counter devices available that purport to electronically stimulate the spinal muscles.  Many are available on Amazon and other websites and are certainly worth a try.  Most patients seek to exhaust the conservative alternatives before resorting to surgery.

Below is a video from the manufacturer or ReActiv8.

I'm Ed Smith, a Sacramento personal injury lawyer.  For nearly four decades, we have worked on behalf of injured Sacramentans.  A car crash can result in years of low back pain, and an experienced attorney can help you get the monetary recovery necessary to reimburse you for your damages.  If you or a family member were injured in an automobile accident caused by another driver's negligence, reach out to us for compassionate, free, and friendly advice.  My local number is (916) 921-6400 or if you are from outside the region (800) 404-5400.  I also respond to inquiries sent via my online contact form.

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