Mainstay Medical International has announced the one-year results from the ReActiv8-A Clinical Trial, an international, multi-centre, prospective, single arm trial for ReActiv8 in people with disabling chronic low back pain and few other treatment options.
The one-year results show sustained performance in the ReActiv8-A Clinical Trial at the one-year follow-up with a clinically important, statistically significant and lasting improvement in the study’s key endpoints for pain (NRS), disability (ODI) and quality of life (EQ-5D).
Peter Crosby, chief executive officer of Mainstay, says, “We are very encouraged to see such strong and lasting benefits in this difficult-to-treat population. After one year of ReActiv8 treatment, 88% of subjects reported a clinically important improvement in one or more of the study endpoints, 81% were satisfied or very satisfied with the treatment and the majority continued to use the ReActiv8 treatment.”
The results presented are based on data from the first 47 subjects implanted in the ReActiv8-A Trial of whom 46 have completed the 90-day follow-up, 45 the 180-day follow-up and 41 the one-year follow-up.
To facilitate future comparison of results in the ReActiv8-A and the ReActiv8-B trial, all outcomes are presented relative to the data collected at the enrolment visit, according to a company release.
Results for all subjects at 90 days, 180 days and 1 year respectively are:
- Ninety-three per cent, 87% and 88% with clinically important improvement in one or more of the study’s key endpoints.
- Sixty-three per cent, 58% and 56% with clinically important improvement in low back pain NRS on the day.
- Fifty per cent, 53% and 59% with clinically important improvement in ODI.
- Eighty-nine per cent, 82% and 80% with clinically important improvement in EQ-5D.
- Sixty-one per cent, 67% and 62% reported>50% pain relief.
- Eighty-nine per cent, 84% and 81% were satisfied with ReActiv8 treatment.
The results for EQ-5D and ODI previously announced were relative to data collected at the pre-implant visit to 90 days and 180 days and were:
- Fifty-sevent per cent and 60% with clinically important improvement in ODI.
- Sixty-seven per cent and 73% with clinically important improvement in EQ-5D.
Adverse events incidence and type were comparable to those in clinical trials reported for other neurostimulation devices, according to the release, with no unanticipated adverse events, and no serious adverse events related to the device, therapy or procedure.