France-based SpineGuard has received additional regulatory clearance from Comision Federal para la Proteccion contra Riesgos Sanitarios (COFEPRIS) to sell its Curved and Curved XS PediGuard devices in Mexico.
Earlier, SpineGuard received regulatory approvals to sell its Classic and Cannulated PediGuard devices.
PediGuard is reportedly the first and only handheld device that is capable of alerting surgeons to potential pedicular or vertebral breaches
The device provides real-time feedback through audio and visual signals.
It also decreases the time by 15% for pedicle screw placement and limits radiation exposure by 25-30%.
According to various study reports published in peer-reviewed medical and scientific journals, PediGuard detects 98% of pedicle breaches and presents an average screw placement accuracy of 97% (vs. 92% on average for navigation).
It also provides three-times fewer pedicle perforations than with free-hand technique and a three-fold reduction in neuro-monitoring alarms, according to the studies.
SpineGuard CEO and co-founder Pierre Jerome noted this additional regulatory approval completes the company’s offering into the substantial market of Mexico.
"Mexico’s spine surgeons will now benefit from all of the PediGuard features, including directionality and miniaturization, thus minimizing complications due to cortical breaches and reducing their exposure to radiation as a result of less dependence on fluoroscopy," Jerome added.
More than 28,000 procedures have been performed with PediGuard on all continents.