SpineGuard has received regulatory approval from the Mexican healthcare regulatory authority COFEPRIS to market its Cannulated PediGuard device.
A handheld device that can quickly alert surgeons to any pedicular or vertebral breaches, PediGuard offers real-time feedback through both audio and visual signals.
So far, more than 25,000 surgical procedures have been performed using this device.
SpineGuard CEO and co-founder Pierre Jérôme said the regulatory approval of Cannulated PediGuard expands the company’s 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," Jérôme added.
Minimally invasive surgical techniques offer multiple benefits, as surgeries take shorter duration and enable patients to quickly recover.
These procedures, however, make surgeons opt for increased use of fluoroscopy in order to compensate for their lack of direct visual landmarks and tactile feel, which in turn exposes OR teams to higher radiation doses.
The Cannulated PediGuard device, which has been co-invented by Dr Maurice Bourlion, Dr Ciaran Bolger and biomedical engineer Alain Vanquaethem, reduces radiation exposure by 25-30% and the time taken for pedicle screw placement by 15%.
The company said PediGuard, through several studies, has proved that it can detect 98% of pedicle breaches, present an average screw placement accuracy of 97%, compared to 92% on average for navigation, provide three-fold less pedicle perforations than with free-hand technique and a three-fold reduction in neuro-monitoring alarms.
Baja California-located Hospital Almater Mexicali Mexico Neurosurgery Service chief Dr Ricardo Flores Escamilla said: "PediGuard’s guidance allows us to place pedicle screws in an optimal way, designed to ensure superior outcomes for our patients."
The company has trained more than 50 spine surgeons to use this device in Mexico.