SpineGuard has obtained additional regulatory clearance from COFEPRIS, the Mexican healthcare regulatory authority, to sell its Curved and Curved XS PediGuard devices in the country. SpineGuard has previously received clearances for its Classic and Cannulated PediGuard devices in Mexico. Surgeons in the country willnow be able to use all of the PediGuard features, including directionality and miniaturisation, thus minimising complications due to cortical breaches and reducing their exposure to radiation as a result of less dependence on fluoroscopy.
PediGuard is claimed to be the world's first and only hand-held device capable of alerting surgeons to potential pedicular or vertebral breaches. Real-time feedback is provided via audio and visual signals. Studies published in peer-reviewed journals have demonstrated that PediGuard detects 98% of pedicle breaches, presents an average screw placement accuracy of 97% (vs 92% on average for navigation), provides three-times fewer pedicle perforations than with free-hand technique and a three-fold reduction in neuro-monitoring alarms. It also limits radiation exposure by 25-30% and decreases by the time for pedicle screw placement by 15%.
The PediGuard device is also CE-marked and approved by the FDA.