SpineGuard, Inc. has announced the world’s first spinal fusion surgery performed with the one-step-insertion of pedicle “smart screws” guided by DSG (Dynamic Surgical Guidance) technology. According to the January 5, 2016 news release, “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.”
SpineGuard: World’s First With Dynamic Surgical Guidance
“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.
SpineGuard CEO and co-founder Pierre Jérôme said: “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. 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.”
Pierre Jérôme told OTW, “With the inclusion of the DSG technology in pedicle screws, we are able to reduce OR time by significantly minimizing the number of steps typically needed to insert those spinal fusion implants safely. This increased efficiency comes with the well-established high accuracy and reduced radiation (surgeon, patient, OR staff) provided by the legacy PediGuard devices.”
Asked where they hope to ‘be’ in one year, he noted, “In one year, we hope to be well on our way to making DSG technology “standard of care” for spinal therapies that require pedicle screw fixation.”
Discussion
This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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