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Procedure is milestone in path to commercial launch of G2S pedicle screw instrumentation.
January 5, 2016
By: SpineGuard Inc.
The first surgery performed with the one-step-insertion of pedicle “smart screws” guided by SpineGuard S.A.’s DSG (Dynamic Surgical Guidance) technology has been completed in France. This surgery was performed successfully by Dr. Court and his team at the Centre Hospitalier Universitaire Bicêtre Paris-Sud in France. Dr. Tropiano in Marseille, France, and Dr. Bolger in Ireland have scheduled surgeries in the coming days. For SpineGuard and Neuro France Implants, who announced their co-development partnership in early 2015, this successful first surgery performed immediately after obtaining CE mark is a critical milestone in preparation for the commercial launch of the G2S pedicle screw instrumentation that integrates the DSG technology. “The direct insertion of pedicle screws along with real-time x-ray-free feedback represents a key step for spine surgery. This first case gave me a glimpse of the great potential of this innovation in terms of safety and precision. A multi-centric study will allow us to substantiate it,” said Charles Court, M.D., orthopedic surgeon at the Centre Hospitalier universitaire Bicêtre Paris-Sud in France. “This pioneering surgery validates the clinical utility of embedding our DSG technology into the vertebral implant itself, thus enabling its insertion without any preliminary step,” said Pierre Jérôme, CEO and co-founder of SpineGuard. “I believe this major technological advancement will further secure and simplify the most commonly performed instrumented spine procedure, fusion.” Patrice Moreau, CEO and co-founder of Neuro France, added, “For 17 years Neuro France Implants has been focusing on simplifying and securing spine surgery through innovative implants. This first direct insertion of our G2S pedicle screws integrating the DSG technology is a real success, our collaboration with SpineGuard is bearing fruit.” Pedicle screw-based fusion has become the gold standard for treating spine instabilities and deformities. The market continues to grow globally due to the increasing number of patients requiring surgical treatment, a larger number of surgeons being trained, and technological advancements such as minimally invasive surgery, bone substitutes and dynamic stabilization. Worldwide there are about one million pedicle screw-based procedures performed annually. However, accuracy of pedicle screw placement remains a critical issue in spine surgery. In recently published papers studying screw placement accuracy, the average rate of misplaced screws is approximately 20 percent, with 2-11 percent of patients presenting neurologic or vascular complications due to misplaced screws. SpineGuard is headquartered in France, and its U.S. offices are in San Francisco, Calif.
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