Mainstay Medical Holdings plc today announced the publication of data from a real-world, single-center study with a one-year clinical follow-up of patients from the ReActiv8®-C Study. Patients implanted with ReActiv8 at Klinikum Itzehoe were sequentially enrolled in this group if they had back pain ≥6 and had no previous lumbar surgery. One-year results published in the journal Neurosurgery in the world The publication showed that the majority of the 44 patients followed had statistically significant improvement in pain (NRS), disability (ODI) and quality of life (EQ-5D-5L).
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This interim analysis indicates that response to ReActiv8 in these patients is persistent and that benefits improve over time, consistent with the restorative mechanism of action and results from the ReActiv8-B randomized clinical trial.
Dr. Said Med. Ardeshir Ardeshir, Senior Physician in the Department of Spinal Surgery at the Clinic for Trauma and Orthopedics, Klinikum Itzehoe: “This real-world positive data is consistent with the ReActiv8-B study, which is critical to me when adopting new technologies. I look forward to continuing to provide restorative neurostimulation using ReActiv8 to my patients with multifidus dysfunction leading to chronic axial low back pain.” “.
Jason Hannon, CEO, Mainstay MedicalAnd the He said: “These real-world results demonstrate the restorative mechanism of action of ReActiv8, which addresses one of the leading causes of chronic, mechanical low back pain, which is multilateral limb dysfunction. German clinicians are among the early adopters of ReActiv8 and we look forward to making the treatment more widely available to patients in this region.”
Link to Real World Evidence on Published Study of Restorative Neurostimulation in Chronic Low Back Pain – Cohort Consecutive Study – ScienceDirect
ReActiv8 is an implantable medical device for the treatment of adults with chronic refractory low back pain (CLBP) associated with multilateral muscle weakness. Multiple muscle dysfunction can be detected by imaging or physiological tests in adults who do not respond to treatment, including pain relievers and physical therapy, and who are not eligible for spinal surgery. ReActiv8 has received regulatory approval in multiple geographies and is commercially available in the European Economic Area, Australia, the United Kingdom and the United States.
About Mainstay Medical
Mainstay Medical is a medical technology company focused on commercializing its innovative ReActiv8 implantable system, ReActiv8®, focused on patients with mechanical CLBP inactivation. Mainstay Medical is headquartered in Dublin, Ireland with subsidiaries in Ireland, USA, Australia, Germany and the Netherlands.
Visit www.mainstaymedical.com for more information.
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Source: Business Wire