Efficacy of ReActiv8® Restorative Neurostimulation™ shows no statistically or clinically meaningful differences between older and younger patient populations.
Mainstay Medical Holdings plc today announced the publication of a pooled analysis of three different clinical studies that evaluated the safety and efficacy of ReActiv8 therapy after two years in patients of various ages. The analysis, published in Regional Anesthesia & Pain Medicine, included 261 patients across the ReActiv8-B, ReActiv8-C, and PMCF studies, with the results demonstrating that age is not a factor when utilizing ReActiv8 to treat intractable mechanical chronic low back pain patients with multifidus dysfunction.
The publication can be found here: https://rapm.bmj.com/content/early/2024/03/08/rapm-2023-105032
There were no statistically significant or clinically meaningful differences between the groups in the magnitude or durability of response across pain, disability, or health-related quality of life measures. A summary of some of the data from the analysis for patients at two years of ReActiv8 therapy is as follows:
Dr Simon Thomson MBBS FFPMRCA, Consultant Lead at the Pain and Neuromodulation Centre, Mid and South Essex University Hospitals NHS, Essex, UK and the London Clinic, former President of International Neuromodulation Society (INS), stated: “Restorative Neurostimulation has proven to be a unique therapy that delivers consistent results in randomized, controlled and real-world studies. Until now it was unknown if age was a factor in predicting long-term outcomes. This pooled analysis demonstrates that properly selected patients can benefit from this therapy, irrespective of age.”
Jason Hannon, CEO of Mainstay Medical, stated: “High quality clinical evidence sets us apart in this industry. We study, learn, and demonstrate outcomes in patient populations before we suggest ReActiv8 is beneficial to a particular group of patients. This is how we partner with clinicians to deliver the best possible, and most durable, treatments for their patients. With these exciting results demonstrating the value of ReActiv8 across all studied age groups, we can now confidently support identification of older patients who are likely to benefit from the therapy. We look forward to continuing to partner with physicians to help chronic low back pain patients of all ages, and to growing the global body of peer-reviewed evidence supporting the ability of ReActiv8 to provide positive long-term outcomes.”
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.