SpineGuard, the company with the stated mission of making spinal surgery safer, has announced 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.
Pedicle screw placement, spinal surgery, the need for high intensity fluoroscopy and the attendant risk of increased physician exposure to radiation are all related themes which crop up periodically on our pages. SpineGuard are on the case however, their PediGuard product aiming to achieve accurate and safe pedicle screw placement with a minimal amount of fluoroscopic control, replacing imaging with sensing technology at the tip of its devices.
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.
Now, in a forthcoming issue of Spine, one research team gives the company’s technology a significant thumbs up, showing reduction in number of fluorosopy shots of 30% while maintaining a high degree of accuracy.
The paper, entitled “Reduction in Radiation [Fluoroscopy] While Maintaining Safe Placement of Pedicle Screws During Lumbar Spine Fusion” will appear in October’s edition of Spine but has been published now ahead-of-print. The principal investigator 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 Chaput PediGuard study was a prospective, randomised, 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.
“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 PediGuard® device is FDA-cleared and CE Marked for pedicle screw placement in spine surgery.
Source: SpineGuard, Business Wire