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
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SpineGuard announced today that data accepted by Spine on July 4, 2012, and published ahead-of-print online demonstrates that the Company’s PediGuard® device reduces spine surgeons’ radiation exposure from fluoroscopy by 30% while maintaining a 97.5% accurate placement of pedicle screws during lumbar spine fusion. Principal investigator for the study (“Reduction in Radiation [Fluoroscopy] While Maintaining Safe Placement of Pedicle Screws During Lumbar Spine Fusion”) was Christopher D. Chaput, M.D., Director of Spinal Trauma and Orthopedic Research at Scott & White Hospital, Temple, Texas; and, Assistant Professor of Surgery at Texas A&M Health Science Center. (The print version of the article will appear in the October 2012 issue of Spine.)
Earlier this month, SpineGuard announced that the 20,000th case has been performed using its family of PediGuard devices for enhanced pedicle screw placement. The PediGuard product line includes Cannulated PediGuard, Curved PediGuard, and Classic PediGuard.
"Patient safety should be a paramount concern for spine surgeons, and incorrect placement of screws is one of the main factors that can put the patient at risk for neurologic and vascular injury. Unfortunately, the intra-operative imaging that we use to help guide and confirm screw placement also carries risks related to radiation exposure, especially to the surgeon over time, and is also a known source for bacterial contamination of the field,” said Dr. Chaput. “Our study showed that the same excellent rate of screw placement could be achieved with the PediGuard, but with significantly less fluoroscopy."
“This is the fifth clinical study of PediGuard that has been published in a major, peer-reviewed medical journal,” said Pierre Jérôme, CEO of SpineGuard. “While the safe placement of pedicle screws continues to be a substantial challenge in spine surgery, awareness of PediGuard as a significant deterrent to radiation exposure associated with the use of fluoroscopy is increasing among OR teams.”
“Like the four previously published studies, the value proposition of PediGuard for spine professionals and their patients has been clearly validated: pedicle breach anticipation, plus reduction of radiation exposure and surgery time,” added Stéphane Bette, Chief Technology Officer and General Manager of U.S. Operations for SpineGuard.
The Chaput PediGuard study was a prospective, randomized, controlled study whose objective was to report the results of using the PediGuard device to reduce radiation exposure while drilling the pilot hole for pedicle screw placement. Reports of pedicle screw placement in the lumbar spine have shown medial pedicle perforations with nerve root impingement in addition to lateral pedicle and vertebral body perforations that can impinge the nerve root. Routine use of fluoroscopy is thought to reduce the risk of perforations but is associated with increased radiation.
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. 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.
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.
SpineGuard’s mission is to make spine surgery safer. The company has offices in San Francisco and Paris. For further information, visit www.spineguard.com.
Contact:
Ronald Trahan Associates Inc.
Ronald Trahan, APR, +1-508-359-4005, x108