Mainstay Medical

Mainstay Medical

Chronic Low Back Pain (CLBP) Restorative Treatment System for Patients - Medical / Health Care

As for many patients, none of the treatment options for your Chronic Low Back Pain (CLBP) have brought you lasting relief. ReActiv8® is a different type of restorative therapy that addresses the underlying multifidus muscle dysfunction that can lead to mechanical CLBP. If you suffer from mechanical CLBP, ReActiv8 is designed to provide you with meaningful, long-term relief.

Details

No one should live their lives in constant pain. If you have mechanical CLBP, it’s time to treat the cause of your pain, not only the symptoms. ReActiv8 Restorative Neurostimulation therapy activates the stabilizing muscles of your low back, focusing on the cause of your pain.

How does it work?
ReActiv8
A restorative treatment with transformative results

For many patients, ReActiv8 goes straight to the source of mechanical CLBP: your multifidus muscle, the primary stabilizer of your lumbar spine. If you suffer from mechanical CLBP, you may be all too familiar with the cycle of pain, muscle deterioration, and movement difficulty. ReActiv8’s restorative therapy can disrupt this cycle of pain and muscle degeneration by painlessly stimulating the nerves of your multifidus muscle and causing beneficial contractions. The ReAtiv8-B clinical study shows that this can significantly reduce mechanical CLBP.

Is ReActiv8 right for you?
  • Surgery
  • No prior lumbar spine surgery and not currently indicated for spine surgery
  • Treatments
  • Physical therapy and medication have not provided lasting pain relief Localized pain
  • Pain is more prominent in low back than legs
ReActiv8placement

During a minimally-invasive procedure, your physician will implant the ReActiv8 system in your lower back. Two electrical leads are positioned to stimulate the nerves that control your multifidus muscle, a stabilizing muscle in your lower back. The leads are connected to the implantable pulse generator which is placed just under the skin in the upper buttock or lower back area.

Patient-controlled therapy

Twice a day, you simply use a remote linked to your ReActiv8 system to start your therapy session — then lie down and relax. For each 30-minute session, ReActiv8 generates painless electrical pulses that cause your multifidus muscle to contract and relax.

Substantial and lasting improvements

After one year, the ReActiv8-B clinical trial showed that 78% of patients were “definitely satisfied” with the treatment. Overall, 64% of patients had reduced their pain by half or more while 73% of participants had a 50% improvement in pain and/or disability. See the data from the clinical trial in the published manuscript in the PAIN Journal. [1]

1 – Gilligan C, Volschenk W, Russo M, et al. An implantable restorative-neurostimulator for refractory mechanical chronic low back pain: a randomized sham-controlled clinical trial. Pain 2021; Article in Press. doi: 10.1097/j.pain.0000000000002258

Patient Testimonials
Backed by real patients with real results

Many people who were treated for their mechanical chronic low back pain with ReActiv8 have seen a dramatic improvement and were eager to share their stories to give hope to others. The following videos contain stories from three of our international patients who experienced remarkable results from the ReActiv8 system. Patients’ stories are theirs only and not indicative of the results for all patients. Patient outcomes will vary. See paragraph below for US indication and product information.