Mainstay is a European medical device company focused on bringing to market an innovative implantable neurostimulation system, ReActiv8, for people with disabling Chronic Low Back Pain. The Company is headquartered in Dublin, Ireland. It has subsidiaries operating in Ireland, the United States, Australia, Germany and the Netherlands.
 

What is Chronic Low Back Pain?

You are not alone if your life is affected by low back pain. Approximately two-thirds of people suffer from low back pain at some time during their life. In nine out of ten people back pain resolves within a few months. However, for 7% back pain becomes a chronic condition¹.

In most cases, low back pain starts as a simple strain or sprain of one of the joints in the spine. In response to joint pain, the brain tries to limit painful movements. One way it does this is by suppressing the activation of the muscles that stabilize the lower back. When this happens, the spine moves more easily into painful positions. This can result in an ongoing cycle of chronic low back pain and muscle weakening.

Many studies show that reactivation of muscle control is an important step to break the vicious cycle of chronic low back pain^2,3. Specific exercise programs offered by physiotherapy specialists can help you regain control of your spine stabilizing muscles⁴. Medical guidelines recommend a supervised exercise program.

If conventional treatment is not enough to restore control of the spine stabilizing muscles, ReActiv8 might be considered as a new option.

Once muscle control improves, your physician may recommend additional muscle strengthening exercises to reduce the risk of future recurrences of back pain.
 

1 Hall, H. & McIntosh, G. Low back pain (chronic). Clin. Evid. (Online). 2008, 1–28 (2008).
2 Hebert, J. J., Koppenhaver, S. L., Magel, J. S. & Fritz, J. M. The relationship of transversus abdominis and lumbar multifidus activation and prognostic factors for clinical success with a stabilization exercise program: a cross-sectional study. Arch. Phys. Med. Rehabil. 91, 78-85 (2010).
3 Costa, L. O. P. et al. Motor control exercise for chronic low back pain: a randomized placebo-controlled trial. Physical therapy 89, 1275-86 (2009).
4 Hauggaard, A. & Persson, A. L. Specific spinal stabilisation exercises in patients with low back pain - a systematic review. Physical Therapy Reviews 12, 233-248 (2007).

ReActiv8 Stimulates Muscles to Relieve Pain

 
 
A New Restorative Neurostimulation Therapy for Mechanical Chronic Low-Back Pain
 
ReActiv8 is a restorative neurostimulation system that treats mechanical chronic low back pain (CLBP). The therapy invokes a rehabilitative mechanism to restore multifidus neuromuscular control of lumbar spine stability. The implantable system delivers stimulation to the medial branch of the dorsal ramus nerve to elicit episodic multifidus contractions. By reactivating muscle control, it restores functional spine stability and reduces pain for patients suffering from mechanical chronic low back pain.

An external programmer communicates wirelessly with the IPG and is used to customize stimulation for each user, and to display the diagnostic information automatically collected and stored in the IPG.

An external wireless activator is used to start and stop stimulation sessions typically for 30 minutes twice a day.
 

How Does ReActiv8 Work?

Many studies show that restoration of muscle activation is an important step in the treatment of chronic low back pain.^1,2

ReActiv8 is a small implanted device that stimulates the nerves responsible for activating the key muscles that stabilize the lower back.

Similar to exercise programs used to restore muscle control³, you deliver ReActiv8 sessions twice a day for about 30 minutes. During the sessions, ReActiv8 will activate the muscles in your lower back. You are always in control of the stimulation session via a handheld wireless remote control.

Over time, the stimulated activation may help your brain and body learn how to better control the muscles in between sessions. Restoration of muscle control and spine stabilization allows your body to recover from chronic low back pain².
 

1 Hebert, J. J., Koppenhaver, S. L., Magel, J. S. & Fritz, J. M. The relationship of transversus abdominis and lumbar multifidus activation and prognostic factors for clinical success with a stabilization exercise program: a cross-sectional study. Arch. Phys. Med. Rehabil. 91, 78–85 (2010).
2 Costa, L. O. P. et al. Motor control exercise for chronic low back pain: a randomized placebo-controlled trial. Physical therapy 89, 1275–86 (2009).
3 Hides, J. A., Jull, G. A. & Richardson, C. A. Long-term effects of specific stabilizing exercises for first-episode low back pain. Spine 26, E243–8 (2001).

Is ReActiv8 Right For Me?

ReActiv8 is designed to provide therapy for people whose lives are significantly impacted by chronic low back pain. The first step in evaluating if ReActiv8 is right for you is to talk with a back pain specialist.

ReActiv8 therapy may be considered as an option if the following describes your situation:

1 – I have had back pain for more than 3 months and it is affecting my ability to function.

2 – I have not had back surgery and my doctor told me it is not for me.

3 – I have completed an expert-guided exercise program and continue to be impaired by low back pain.

4 – I am motivated to explore a new option.

ReActiv8 is CE marked for the treatment of chronic low back pain and available for sale in Europe. Mainstay Medical is prohibited from providing medical information directly to individuals. Please contact your personal physician to address questions concerning your individual health situation.

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