medtechmatters.com® Blog
medtechmatters.com® Blog
SAFER SPINE SURGERY?
Can we make spine surgery even safer? Preliminary data from a postmarketing study of SpineVision®’s PediGuard™ device suggest there is a very strong clinical trend that using PediGuard makes spine surgery safer—not only for patients but for surgeons too.
PediGuard is the first and only FDA-cleared Class II device for real-time detection of possible penetration outside the vertebral pedicle. Accuracy of pedicle screw placement is still an issue in spine surgery: published rates of intraoperatively “misplaced” pedicle screws range from 10 to 40 percent, some of which result in pathological consequences such as spinal cord damage, including paraplegia or tetraplegia. Consequently, liability risks for spine surgeons are high.
In this episode, Dr Randy Betz, an orthopaedic spine surgeon and Chief of Staff at Shriners Hospitals for Children, Philadelphia, who is Principal Investigator for an ongoing, multi-site, randomized postmarketing study of PediGuard, presents the study’s preliminary data.