Mazor Releases Impressive Early Data from Spine Study

Mazor released early results from their ongoing MIS reFRESH study, which is comparing robot-guided thoracic, lumbar or lumbosacral spinal fusions to freehand or fluoro-guided techniques based on endpoints like intraoperative X-ray exposure, surgical complications and need for revision. Among the 379 patients analyzed in this cohort (of a planned total enrollment of 2000), investigators found lower rates of complications and revisions among the patients who had robot-guided procedures. Specifically, the risk of adverse events or complications was 5.3 times higher in the fluoro-guided group (92 subjects at the time of analysis) compared to the robot-guided arm (287 subjects). Further, relative risk for revision surgery was 7.1 times higher in the fluoro-guided group. Both results were statistically significant.

If these results are maintained over the larger study cohort, they will represent compelling evidence for the benefit of robot-assisted techniques in orthopedic and spine surgery.

The company has a strategic partnership with Medtronic for the worldwide distribution of the Mazor X system that has been in place since 2016, though Mazor has said they plan to keep their technology open and compatible with any devicemaker’s implants. Medtronic recently invested an additional $40 million in the company, which was accelerated based on “the early achievement of certain sales and marketing milestones by both companies, as well as higher than expected global market acceptance and demand for the Mazor X system.” Medtronic has now invested a total of $72 million in Mazor.