Genesys Spine’s SIros lateral SI joint fusion system was found to be safe and effective following a multicenter clinical study, the company said in a Feb. 6 news release.
The study, published in Pain Physician Journal, showed a 38% reduction in pain scores by six months, and functional outcomes improved significantly. The Oswestry Disability Index improved from a baseline of 50.3% to 34.9%, a transition from severe to moderate disability.
Radiographic assessments found that 96% of patients in the study had bone apposition to both iliac and sacral sides across at least two of the three implants, and 72% of them had bridging across the SI joint at six months.
There were no reports of implant failure, device migration or procedure-related serious adverse events.
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