PEDIGUARD

PediGuard for accessing the pedicle safely in spine operations
 
PediGuard uses electrical conductivity differentiation at its tip for assessing bone versus soft tissue in order to improve the safe positioning of pedicle screws. PediGuard not only warns of impending medial breach but also is the only real-time device available to non-radiographically detect lateral breach. 

About the PediGuard® platform

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. More than 20,000 procedures have been performed with PediGuard on all continents. Several studies published in peer-reviewed medical and scientific journals have demonstrated that PediGuard presents an accuracy rate as high as 97.5%, doubles the pedicle breach-detection rate, limits radiation exposure by up to 73%, decreases by 15% the average time for pedicle screw placement and provides a 3-fold reduction in neuro-monitoring events. 

In the Chaput study, because of the use of PediGuard, the number of fluoroscopy shots was able to be reduced by 30% compared to a standard drilling probe while maintaining a 97.5% accurate, safe screw placement.

Spine surgeons’ increasingly greater reliance on fluoroscopy during procedures exposes the entire OR team to dangerous radiation:

• The average spine surgeon will receive the maximum allowable lifetime exposure of radiation for classified workers within 10 years of practice (Ul Haque, Shufflebarger et al, 2006);
• The radiation exposure in spine surgery has been found to be 10 to 12 times greater than the radiation exposure during other fluoroscopically assisted non-spinal musculoskeletal procedures (Rampersaud, 2000);
• The highest amount of fluoro intensity is needed for spinal procedures (Orthopedics this Week, 2010).

Co-founded in 2009 by Pierre Jérôme and Stéphane Bette, former executives at Medtronic Sofamor-Danek and SpineVision, SpineGuard’s primary objective is to establish its FDA-cleared and CE Marked PediGuard® device as the global standard of care for safer pedicle screw placement in spine surgery.

 
SpineGuard’s PediGuard® Device Reduces by 30% Spine Surgeons’ Radiation Exposure from Fluoroscopy While Maintaining a 97.5% Accurate Pedicle Screw Placement During Lumbar Spine Fusion:Prospective, randomized, controlled study results published in Spine