SpineVision(R) announced today that it has now trained 250 U.S. spine surgeons to use PediGuard(TM), 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 quadriplegia. Consequently, liability risks for spine surgeons are high.
