SpineGuard Reports 10,000th Spine Procedure Using PediGuard® for Safer Pedicle Screw Placement

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SAN FRANCISCO & PARIS–(BUSINESS WIRE)–SpineGuard announced today that the 10,000th case has been performed using its PediGuard® device for safer pedicle screw placement in spine surgery.

“Safe placement of pedicle screws continues to be the number-one challenge in spine surgery”

Nearly one million1 spine procedures using pedicle screws were performed in 2008. According to published studies, pedicle screws show high rates of misplacements that can lead to a number of serious complications for patients, including quadriplegia. Consequently, liability risks for spine surgeons are high.

“PediGuard will probably become a standard tool in any spine surgery requiring instrumentation,” said Randal Betz, M.D., Chief of Staff, Shriners Hospitals for Children, Philadelphia. “Anything we can do to help us get a safer screw insertion is certainly worthwhile, given that published rates of pedicle screw misplacements are as high as 20 percent. PediGuard makes spine surgery safer for surgeons also. Fluoroscopy (a type of X-ray) is an imaging technique commonly used by physicians to obtain real-time images of the spine during surgery. While the exposure to a patient during one surgery is minimal, spine surgeons may perform 140 or more cases per year. Studies are showing that the use of PediGuard reduces fluoroscopy time by one-third in some surgeons’ cases. Less use of fluoroscopy per case means significantly less accumulated radiation exposure over the course of a typical year’s worth of cases.”

“As a PediGuard user for over eight years, I have enjoyed using this device for pedicle screw insertion,” added André Kaelin, M.D., Chief, Department of Paediatric Orthopaedics, Children’s Hospital, Geneva, Switzerland. “After training and a brief learning curve, you add a third sense—the auditory—as an additional help for pedicle preparation. With time, the sound frequency and tone becomes a preeminent part of your technique. For a University Hospital, PediGuard is an invaluable teaching tool: you can assist your residents and ensure safe control of their actions.”

Tom Barton, a U.S. agent for SpineGuard, commented: “The PediGuard allows me, as a salesperson, to represent a truly unique and non-threatening product that puts patient safety and optimal outcomes first, while seamlessly complementing my surgeons’ technique.”

“Safe placement of pedicle screws continues to be the number-one challenge in spine surgery,” said Pierre Jérôme, CEO of SpineGuard. “Now, with 10,000 spine procedures performed on all continents, PediGuard is on its way to becoming an irresistible solution to the well-documented clinical need for safer pedicle screw placement in spine surgery.”

“Several peer-reviewed publications now validate the value proposition of PediGuard for spine professionals and their patients: 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.

Co-founded this year 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.

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