Mainstay Medical’s one-year study of its neurostimulation system for the treatment of chronic low back pain (CLBP) has demonstrated the system’s value over the standard of care (SoC).
The Irish device company’s ReActiv8 Restorative Neurostimulation system is a restorative therapy designed to stimulate the nerves of the multifidus (MF) muscle which is responsible for stabilising an individual’s lumbar spine. The system received approval from the US Food and Drug Administration (FDA) in 2020.
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A surgically implanted device, ReActiv8 is comprised of a pulse-generating console and two wires inserted on either side of the spine, close to the nerves responsible for activating key muscles, primarily the MF, which stabilise the lower back.
Mainstay’s study, the results of which have been published in the journal Pain and Therapy, randomised 203 patients into a treatment or control arm.
The study met its primary endpoint of change of mean improvement in the Oswestry Disability Index (ODI) score between treatment and control arms at the one-year follow-up and achieved statistical significance of ODI -19.7 ± 1.4 for the ReActiv8 arm versus -2.9 ± 1.4 in the control arm.
Secondary endpoints met in the study’s control arm included mean improvement in back pain, as measured using the 11-point Numeric Rating Scale (NRS), and mean improvement in healthcare-related quality of life measured using the EQ-5D-5L assessment.
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By GlobalDataThe study’s steering committee said the results demonstrated that ReActiv8 Restorative Neurostimulation provided superior improvements to the lives of patients beyond the SoC measures such as physical therapy or pain medication.
Mainstay Medical CEO Jason Hannon commented: “These high-quality data showing the treatment benefit of ReActiv8 compared to the current standard of care meaningfully add to the growing body of clinical evidence regarding ReActiv8 and firmly establishes the critical role of this therapy in treating intractable mechanical low back pain patients.
“We look forward to leveraging these data, along with the compelling results from our ReActiv8-B clinical trial and our numerous other studies, to further engage payers in the US to expand commercial insurance access to this transformational therapy, which has the potential to deliver significant reductions in overall healthcare costs.”
ReActiv8, which is commercially available in Europe, Australia, and the UK, is currently the only therapy approved in the US for treating CLBP caused by MF dysfunction.
Breakdown of the MF is thought to be a primary driver in low back pain (LBP), which can lead to CLBP over time. According to the World Health Organization (WHO), LBP affects 619 million people worldwide. It forecasts that LBP will increase to 843 million cases globally by 2050, driven by factors such as population growth and ageing, physical inactivity, obesity, and muscle weakness that may potentially be hereditary.
