Mainstay announces publication of post-market data from ongoing chronic low back pain study

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Mainstay Medical has announced the publication of data from a single-centre, real-world study with one-year clinical follow-up of patients selected from its ReActiv8-C study, with the results further supporting the efficacy and use of ReActiv8 restorative neurostimulation for the treatment of intractable chronic low back pain.

Patients implanted with ReActiv8 at Klinikum Itzehoe (Itzehoe, Germany) were consecutively included into this cohort if they presented with back pain ≥6 on the numeric rating scale (NRS) and no prior lumbar surgery.

The one-year results, published in World Neurosurgery, showed that a majority of the 44 patients followed up with demonstrated statistically significant improvements in pain (NRS), disability (Oswestry Disability Index [ODI]) and quality of life (EQ-5D-5L).

This interim analysis indicates that the response to ReActiv8 for these patients is durable and the benefits improve over time, consistent with both a restorative mechanism of action and the ReActiv8-B randomised clinical trial results, according to a press release from Mainstay.

“These favourable real-world data are consistent with the ReActiv8-B study, which is extremely important for me in adopting new technologies,” said Ardeshir Ardeshiri (Klinikum Itzehoe). “I am excited to continue offering restorative neurostimulation with ReActiv8 for my patients with multifidus dysfunction resulting in chronic axial low back pain.”

Jason Hannon, CEO of Mainstay, added: “These real-world results further validate ReActiv8’s restorative mechanism of action, which treats a primary underlying cause of mechanical chronic lower back pain, multifidus dysfunction. German physicians have been some of our foremost implanters of ReActiv8, and we look forward to continuing to make the therapy more broadly available to patients in this region.”


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