SpineGuard, S.A., has announced 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., in the July 2, 2013 news release. Dr. Escamilla is chief of Neurosurgery Service at the Hospital Almater Mexicali in Baja California, Mexico.
“The regulatory approval of Cannulated PediGuard expands our product offering in the important market of Mexico, where minimally invasive spine surgery (MIS) 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.
Co-invented by Maurice Bourlion, Ph.D., Ciaran Bolger, M.D., Ph.D., and Alain Vanquaethem, biomedical engineer, PediGuard is the world’s first and only handheld 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% of pedicle breaches, presents an average screw placement accuracy of 97% (vs. 92% on average for navigation), provides three-fold less pedicle perforations than with free-hand technique and a three-fold reduction in neuro-monitoring alarms. It also limits radiation exposure by 25-30% and decreases by 15% the time for pedicle screw placement.
Pierre Jérôme told OTW, “Mexico is one of the largest spine markets, especially for minimally invasive surgery (MIS), which is growing rapidly in that country. Also, our Mexican commercial partner has done a great job at driving PediGuard adoption.”
“We have been working on the Cannulated PediGuard registration in Mexico since the product got CE marked over a year ago. Our goal is that in one year we will have performed about 50 cases a month with PediGuard.”
