Mainstay Medical has announced the publication of two-year patient outcomes data from its pivotal ReActiv8-B clinical trial. The data, which are published in Neuromodulation: Technology at the Neural Interface, confirm the efficacy and safety of the company’s implantable ReActiv8 device in restorative neurostimulation, and also demonstrate compelling long-term durability and improvement over time on key outcome measures in the treatment of intractable chronic low back pain, according to a Mainstay press release.
On virtually all key efficacy measures, the release continues, the two-year data show improvements over data from the patients’ one-year visits—including 71% of patients reporting pain intensity (visual analogue scale [VAS] score) reduced by 50% or more from baseline at two years, compared to 64% at one year, and 60% of patients who were taking opioids at baseline voluntarily eliminating or reducing their opioid use at two years, compared to 48% at one year.
In addition, 61% of patients reported a greater than 20-point reduction on the Oswestry Disability Index at two years, compared to 57% at one year, and 65% of patients reported a VAS score <2.5 at two years, compared to 52% at one year.
Overall, 76% of patients experienced substantial, clinically meaningful improvements in pain or disability, or both, at two years, the study concludes. Two-year data were available for 156 patients, while one-year data were obtained from 176 patients, according to the release.
Chris Gilligan, director of the Brigham and Women’s Spine Center at Brigham and Women’s Hospital, and assistant professor of Anaesthesia at Harvard Medical School (Boston, USA), said: “The recently published data from the ReActiv8-B clinical trial showed clinically meaningful improvements in both pain and function for patients with refractory chronic low back pain who received two years of neurostimulation.
“Pain scores in patients have decreased substantially from an average of 7.3 to 2.4 and are sustained for the duration of two years and longer with ongoing data collection. These long-term data are extremely important and encouraging given the chronic and refractory nature of this condition.”
Jason Hannon, CEO of Mainstay, added: “These impressive results represent an important milestone for Mainstay, as the profound improvements in patient outcomes we observed from baseline to one year to two years validate the restorative nature of the therapy and represent a new paradigm among treatments available to patients with intractable chronic low back pain.
“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, evidence which continues to expand through multiple clinical trials.”
The release also states that the ReActiv8-B trial patient cohort continues to be evaluated to generate additional data on longer-term efficacy.