ReActiv8-B Trial 3-Year Patient Outcomes Data Publication in Neuromodulation
DUBLIN–(BUSINESS WIRE)–Mainstay Medical Holdings plc today announced the publication of the three-year patient outcomes data from its pivotal ReActiv8-B clinical trial. The data, published in the journal of the International Neuromodulation Society, Neuromodulation, further establish the efficacy and safety of ReActiv8 Restorative Neurostimulation, including compelling long-term durability and improvement over time on key outcome measures in the treatment of intractable chronic low back pain.
*Percent of patients that were on opioids at baseline: (1-year=31/65), (2-Year= 34/57), (3-Year= 36/51).
Overall, 83% of patients experienced substantial and clinically meaningful improvements in pain or disability, or both, at three years.
Chris Gilligan, Director of the Brigham and Women’s Spine Center at Brigham and Women’s Hospital, assistant professor of Anesthesia at Harvard Medical School (Boston, USA), and Principal Investigator of the study, said: “The recently published data from the ReActiv8-B clinical trial continued to show clinically meaningful improvements in both pain and function for patients with refractory chronic low back pain who received three years of neurostimulation. The long-term trajectory and durability of clinical benefits are consistent with the restoration of neuromuscular control and muscle rehabilitation, which gives us confidence that we are able to treat the underlying cause of chronic low back pain in these patients.”
“Multifidus dysfunction in patients with chronic low back pain has historically been a challenging etiology for the spine surgeon community to properly treat,” said Frank Schwab, Chair of Orthopedic Spine Surgery at Lenox Hill Hospital, and Chief of Orthopedic Spine Surgery for Northwell Health System. “These patients are not indicated for surgery, with existing treatment options being temporary and palliative. ReActiv8 therapy has proven to maintain effectiveness long-term and provides this challenging patient population with a safe and restorative solution.”