The Clinical Need
Pedicle screw-based stabilization has become the gold standard for treating spine instabilities and deformities. Technological advancements such as minimally invasive surgery, bone substitutes, dynamic stabilization and thoracic screws further reiterate the importance of pedicle screw placement in spine surgery.
However, accuracy of pedicle screw placement remains a critical issue in spine surgery:
- 10-40% of pedicle screws have been reported as misplaced.
- 2-10% of that number has resulted in pathological consequences.
PediGuard technology has demonstrated strong results in a wide number of clinical studies with more studies forthcoming.
- 98 % breach detection and 87 % breach anticipation.
- 97 % screw placement accuracy.
- 3 times fewer pedicle perforations.
- 3-fold reduction in neuro-monitoring alarms
- 15 % time saving
With initial results of U.S. and European multi-centric clinical studies confirming its potential, the PediGuard® is emerging as the most compelling answer to this clinical need for safer pedicle screw placement. More than 14,000 procedures have been performed with PediGuard® on all continents.
An innovative solution
PediGuard® is the first and only handheld, wireless device that can detect possible vertebral cortex perforation during pedicle preparation for screw placement.
It can alert the surgeon prior to a breach by accurately analyzing the electrical conductivity of the surrounding tissues in real time.
- 99% probability of detection if there is a breach.
- Doubles the detection rate, even small breaches can be detected.
- Time saving technique, reduces screw placement time.
- Decreases radiation exposure by up to 30%.
How it works
The tip of PediGuard has an electromagnetic sensor that can monitors real time changes in electrical conductivity.
It can alert surgeons with changed in flashing LED cadence and in sound pitch and cadence.
If the tip is in the cancellous bone a medium pitch and cadence/sound will be heard, if the tip approaches the cortical bone, a low pitch and cadence/sound will be heard and if there is an imminent cortical breach, a high pitch and cadence/sound will be heard.
Easy to use for Surgeons and staff
PediGuard is always ready to use in sterile packaging, no change required in surgical technique, with a brief learning curve.
The device is completely wireless, thus makes it a cost effective option since no leads, cables, or computers being used.
For more information, kindly visit www.spineguard.com