SpineGuard announced today that it 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.
“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, M.D., Neurosurgeon, Chief of Neurosurgery Service, Hospital Almater Mexicali, Baja California, Mexico.
The use of minimally invasive surgical (MIS) techniques provides substantial benefits for patients, including shorter surgery times and quicker recovery. However these new procedures also induce increased use of fluoroscopy by surgeons to compensate for their lack of direct visual landmarks and tactile feel, exposing OR teams to excessive doses of radiation.
“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, CEO and co-founder of SpineGuard.