Thursday, September 07, 2023
Mainstay Medical Holdings plc has released an update in response to a statement issued by the International Society for the Advancement of Spine Surgery (ISASS) regarding Restorative Neurostimulation for Chronic Mechanical Low Back Pain Resulting from Neuromuscular Instability. This statement, featured in the August edition of the International Journal of Spine Surgery, can be accessed through the provided link.
The ISASS Statement firmly asserts that there exists substantial clinical evidence endorsing restorative neurostimulation as a highly effective treatment for chronic mechanical low back pain, demonstrating enduring clinical benefits when compared to the pre-treatment condition. It strongly recommends this therapy for well-considered patients grappling with chronic mechanical low back pain originating from multifidus dysfunction. It's noteworthy that Mainstay's ReActiv8® Restorative Neurostimulation™ stands as the sole approved therapy for this indication in the United States, Europe, and Australia.
Jason Hannon, Chief Executive Officer of Mainstay Medical, expressed his contentment with ISASS's publication of this Statement and their acknowledgment of the advantages that ReActiv8 offers to patients and healthcare payers. He emphasized that this recognition aligns with the increasing support from various medical societies, such as the Clinical Guidelines issued by the American Society of Pain and Neuroscience (ASPN) and the Position Statement released by the Pacific Spine and Pain Society (PSPS).
About ReActiv8®: ReActiv8 is an implantable medical device specifically designed to address chronic low back pain in adults attributed to multifidus muscle dysfunction. The presence of this dysfunction can be confirmed through imaging or physiological testing in adults who have not responded to conventional therapies, including pain medications and physical therapy, and who are deemed unsuitable candidates for spine surgery. ReActiv8 has received regulatory approvals in multiple regions and is available for use in the European Economic Area, Australia, the UK, and the United States.