Pytheas Your Guided Trajectory

PYTHEAS Your Guided Trajectory is intended as an aid for use in open pedicle cannulation and screw delivery procedures in the thoracic, lumbar and sacral spine in skeletally mature patients as an augment to standard surgical technique. When used in conjunction with preoperative CT imaging and planning, the system can be used in two operating modes – Global Mode and Specific Mode: Global Mode may be used from T10 to S1 range to provide angular guidance to the surgeon for assessing the angle of approach relative to gravity. Specific Mode may be used from T1 to S1 range to provide angular guidance to the surgeon for assessing the angle of approach relative to digitized landmarks obtained on each vertebra. The system requires a user defined pedicle entry point, ascertained by visual analogy between intraoperative scene or intraoperative fluoroscopy compared to preoperative CT based imaging. The device is not intended to replace a surgeon's judgement or standard surgical technique methods.

PYTHEAS Your Guided Trajectory is intended as an aid for use in open pedicle cannulation and screw delivery procedures in the thoracic, lumbar and sacral spine in skeletally mature patients as an augment to standard surgical technique. When used in conjunction with preoperative CT imaging and planning, the system can be used in two operating modes – Global Mode and Specific Mode: Global Mode may be used from T10 to S1 range to provide angular guidance to the surgeon for assessing the angle of approach relative to gravity. Specific Mode may be used from T1 to S1 range to provide angular guidance to the surgeon for assessing the angle of approach relative to digitized landmarks obtained on each vertebra. The system requires a user defined pedicle entry point, ascertained by visual analogy between intraoperative scene or intraoperative fluoroscopy compared to preoperative CT based imaging. The device is not intended to replace a surgeon's judgement or standard surgical technique methods for controlling screw placement. The system is not intended to control for patient anatomical movement.

The PYTHEAS YGT device is designed to assist the surgeon during open pedicle cannulation and screw delivery procedures in the thoracic, lumbar and sacral spine in skeletally mature patients as an augment to standard surgical technique. The device provides real-time, visual angle of approach information to the surgeon as an additional source of feedback during standard open freehand technique and helps with blind pedicle screw cannulation and screw insertion. This feedback is not intended to replace existing procedure safeguards such as intra-operative imaging and haptic feedback. The system relies on user identification of each vertebral level and entry point to provide accurate angular guidance, where system performance is relied upon once the user intraoperatively confirms entry point and vertebral level visually and radiographically against what was preoperatively defined. No clinical benefit has been demonstrated or is claimed.