DUBLIN--(BUSINESS WIRE)--Mainstay Medical Holdings plc today announced that the International Society for the Advancement of Spine Surgery (ISASS) has published a Statement on Restorative Neurostimulation for Chronic Mechanical Low Back Pain Resulting from Neuromuscular Instability. The Statement was published in the August issue of the International Journal of Spine Surgery and can be accessed here: https://www.ijssurgery.com/content/early/2023/08/09/8525.
The Statement concludes that restorative neurostimulation for chronic mechanical low back pain is supported by several clinical studies that show robust and durable clinical effects over the pretreatment condition and recommends the therapy for well-selected patients with mechanical chronic low back pain caused by multifidus dysfunction. Mainstay’s ReActiv8® Restorative Neurostimulation™ is the only therapy approved in the United States, Europe and Australia for this indication.
“We are pleased that ISASS has published this Statement and recognized the benefits ReActiv8 can provide patients and payers,” stated Jason Hannon, Chief Executive Officer of Mainstay Medical. “This builds upon the growing society support for ReActiv8 Restorative Neurostimulation, following the publication last year of the Clinical Guidelines by the American Society of Pain and Neuroscience (ASPN) and the ReActiv8 Position Statement from the Pacific Spine and Pain Society (PSPS).”
About ReActiv8®
ReActiv8 is an implantable medical device designed to treat adults with intractable chronic low back pain (CLBP) associated with multifidus muscle dysfunction. Multifidus muscle dysfunction may be evidenced by imaging or physiological testing in adults who have failed therapy including pain medications and physical therapy, and who are not candidates for spine surgery. ReActiv8 has received regulatory approval in several geographic areas, and is commercially available in the European Economic Area, Australia, the UK, and the US.
About Mainstay Medical
Mainstay Medical is a medical device company focused on commercializing its innovative implantable Restorative Neurostimulation system, ReActiv8, for people with disabling mechanical CLBP. Mainstay Medical is headquartered in Dublin, Ireland and has subsidiaries operating in Ireland, the United States, Australia, Germany, and the Netherlands.
Further information can be found at www.mainstaymedical.com.
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