Sam Brusco, Associate Editor09.29.22
Mainstay Medical has published three-year patient outcomes from its pivotal ReActiv8-B clinical trial in the Neuromodulation journal.
Trial data established ReActiv8 Restorative Neurostimulation’s safety and efficacy, including compelling long-term durability and improvement over time to treat intractable chronic low back pain.
Three-year data showed improvements over results from one-year and two-year visits on virtually all key efficacy measures. Overall, 83% of patients had substantial and clinically meaningful improvements in pain or disability, or both, at three years.
"These 3-year results further validate ReActiv8’s restorative mechanism of action, which treats a primary underlying cause of mechanical chronic lower back pain, multifidus dysfunction,” Jason Hannon, CEO of Mainstay Medical told the press. “We are proud to have the only commercially available device with a strong safety profile and long-term, peer-reviewed evidence supporting the rehabilitation of this severely affected patient population, and we look forward to continuing to generate clinical and other research to compel physicians and their patients to further utilize the therapy.”
Trial data established ReActiv8 Restorative Neurostimulation’s safety and efficacy, including compelling long-term durability and improvement over time to treat intractable chronic low back pain.
Three-year data showed improvements over results from one-year and two-year visits on virtually all key efficacy measures. Overall, 83% of patients had substantial and clinically meaningful improvements in pain or disability, or both, at three years.
"These 3-year results further validate ReActiv8’s restorative mechanism of action, which treats a primary underlying cause of mechanical chronic lower back pain, multifidus dysfunction,” Jason Hannon, CEO of Mainstay Medical told the press. “We are proud to have the only commercially available device with a strong safety profile and long-term, peer-reviewed evidence supporting the rehabilitation of this severely affected patient population, and we look forward to continuing to generate clinical and other research to compel physicians and their patients to further utilize the therapy.”