Successful first in human for ZygoFix’s spinal facet joint fixation system
ZygoFix announced the successful start of a first In human clinical study for its zLOCK spinal facet joint fixation system. The clinical study comprised several procedures to date and a 6-month follow-up of the first case. The first case, a fusion procedure using the zLOCK system, was performed on a 67-year-old female suffering from severe back and leg pain. The patient reported a drop in her VAS (Visual Analog Scale of 0-10 for pain measurement) from 9 pre-operation, to 1 one day post-operation and to 0 at 6 months post-op.
Spinal fusion is a common surgical procedure for the treatment of severe back and leg pain due to conditions such as degenerative discs or “slipped” discs. Spinal fusion is one of the most common surgical procedures — fifth in terms of OR procedure frequency*.
The zLOCK implant is designed as a miniature facet fusion cage to stabilize the segment. Its unique combination of rigid and flexible elements withstands loads and accommodates the anatomy of any facet joint. zLOCK utilizes the natural anatomy of the spine to form a “bridge” between the two adjacent vertebrae, without screws and rods. A percutaneous approach allows placement of zLOCK with only one small incision per side, making it significantly less invasive than the standard pedicle screw procedure.
Prof. Attila Schwarcz, Vice-Chairman and Leader of Spine Surgery, Department of Neurosurgery, University of Pecs, Hungary, and principal investigator in ZygoFix’s study, commented, “The zLOCK implantation is a significantly less invasive procedure compared to other posterior spinal stabilization systems. It appears superior to pedicle screw procedures, since zLOCK has an almost zero risk of causing nerve root injury that can happen in pedicle screw misplacement. Additionally, the zLOCK implant may have the ability to provide better long-term stabilization due to solid bony fusion of the facet joints.”
ZygoFix CEO Ofer Levy remarked, “We are extremely pleased with this successful start to our clinical study — another step toward making spinal fusion simpler, faster and less invasive. zLOCK’s unique design simplifies fusion procedures by self-adjusting to the spine’s anatomy, eliminating the need for pedicle screw placement.”