Additional data from 13 patients participating in the ReActiv8-A clinical trial, who had not yet reached the 180-day follow-up at the time of the Mainstay’s last announcement, has been released.
The additional results from the international, multi-centre, prospective, single arm trial to gather data for a submission for CE marking for ReActiv8 are consistent with previous results, and constitute clinically important, statistically significant and lasting improvement in pain, disability and quality of life in the clinical population.
The ReActiv8-A trial population was relatively young (mean age 43.9 years) and had a long history of low back pain (mean 13.8 years). All of the subjects had attempted physical therapy, and 70% were taking opioids for back pain. The results presented are based on data from the first 47 subjects implanted in the ReActiv8-A trial of whom 46 have reached the 90 day follow up and 45 have reached the 180 day follow up.
- Clinical performance of ReActiv8 at 90 days compared to baseline for all subjects is:
- 63% with clinically important improvement in back pain defined as ≥2 point reduction on the 0-10 Numerical Rating Scale (NRS) for low back pain measured on the day.
- 57% responder rate for pain: A responder is defined as a subject with a clinically important improvement in mean of prior 7 days NRS with no clinically significant increase in medications taken for low back pain.
- 57% with a clinically important improvement in disability on the Oswestry Disability Index (ODI).
- 67% with a clinically important improvement in quality of life on the EQ-5D scale.
- Clinical performance at 90 days is even better for the group of subjects who do not receive financial compensation for being out of work due to their back pain. For those 32 subjects the results are:
- 72% with clinically important improvement in low back pain NRS on the day.
- 69% responder rate for pain.
- 63% with clinically important improvement in ODI.
- 69% with a clinically important improvement in EQ-5D.
- Improvements in low back pain, disability and quality of life were generally consistent or improved at 180 days (n=45). Paired data for all subjects at 90 and 180 days respectively are:
- 63% and 58% with clinically important improvement in low back pain NRS on the day.
- 57% and 60% with clinically important improvement in ODI.
- 67% and 73% with clinically important improvement in EQ-5D.
- 61% and 67% reported >50% Percent Pain Relief.
- Adverse Events (AEs) incidence and type were comparable to AEs in clinical trials reported for other neurostimulation devices, with no unanticipated AEs and no serious AEs related to the device, therapy or procedure.
- The observed lead migration incidence (<1%) demonstrates that the ReActiv8 lead mitigates the risk of lead migration identified with commercially available neurostimulation leads in the earlier feasibility trial.
- In the August press release, the Company announced a modification of the implant technique with different lead routing developed to mitigate the risk of breaks of the wires inside the lead, which had been observed in the ReActiv8-A Experience to date with the first 14 subjects implanted with the modified approach (new implants and revisions) are encouraging.
Mainstay announced on 2 November, 2015 that a submission for CE marking was made.
Subjects continue to be enrolled in the ReActiv8-A trial to gather additional data on performance and safety which the Company plans to incorporate into the Post Market Clinical Follow Up. To date there have been 6 additional subjects implanted in the ReActiv8-A trial.