Zyga Technology announced publication of clinical outcomes for the first 50 patients in the EVoluSIon Clinical Study (EVSI), a multi-center 250-patient trial investigating long-term fusion and pain reduction with use of the SImmetry® Sacroiliac Joint Fusion system.
At 6 months, mean low back pain demonstrated a significant 54% reduction, with 72% of patients reaching the minimal clinically important difference. A 55% reduction in opioid use was reported to be much greater than previously cited in other studies. One- and two-year follow-up will assess the presence of bony fusion across the joint, as well as ongoing pain reduction.
EVSI builds on the findings of an earlier study, announced in 2Q17, which demonstrated that at two years, 94% of patients showed evidence of bridging bone across the fusion site; of those, 83% were categorized as solid fusion.
Sources: Zyga Technology, Inc.; ORTHOWORLD Inc.
Image courtesy of Zyga Technology, Inc.