SpineGuard has obtained regulatory clearance from COFEPRIS, the Mexican healthcare regulatory authority, to sell its cannulated PediGuard device in Mexico. SpineGuard has previously received clearance for its classic PediGuard device, and over 50 Mexican spine surgeons have been trained on the technology.
Cannulated PediGuard provides real-time information that enables spine surgeons to accurately place pedicle screws while avoiding cortical breaches and reducing their exposure to radiation as a result of less dependence on fluoroscopy. PediGuard is co-invented by Dr Maurice Bourlion, Dr Ciaran Bolger, and Alain Vanquaethem, Biomedical Engineer. 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.
Over 25,000 procedures have been performed with PediGuard on all continents. Several studies published in peer-reviewed medical and scientific journals have demonstrated that PediGuard detects 98 per cent of pedicle breaches, presents an average screw placement accuracy of 97 per cent (vs 92 per cent on average for navigation), provides three-fold fewer pedicle perforations than with free-hand technique and a three-fold reduction in neuro-monitoring alarms. It also limits radiation exposure by 25 to 30 per cent and decreases by 15 per cent the time for pedicle screw placement.