SpineGuard has announced that it now has regulatory clearance from COFEPRIS (the Mexican healthcare regulatory authority) to sell its cannulated Pediguard device in Mexico. It has already received clearance for its classic Pediguard device.
“Pediguard’s guidance allows us to place pedicle screws in an optimal way, designed to ensure superior outcomes for our patients,” said Ricardo Flores Escamilla, Neurosurgeon, Chief of Neurosurgery Service, Hospital Almater Mexicali, Baja California, Mexico.
“The regulatory approval of cannulated Pediguard expands our product offering in the important market of Mexico, where minimally invasive spine surgery is progressing rapidly. Cannulated Pediguard is designed to facilitate and secure this challenging procedure, providing real-time information that empowers 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,” said Pierre Jérôme, chief executive officer and co-founder of SpineGuard.