Spinal Elements receives US FDA approval for Sapphire X device

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Spinal Elements has announced US Food and Drug Administration (FDA) clearance of the Sapphire X device for anterior cervical fixation. Sapphire X is the newest product in its MIS [minimally invasive surgery] Ultra suite of products aimed at minimising the unintended consequences of traditional spine surgery, Spinal Elements said in a press release.

The Sapphire X anterior cervical fixation system features integrated instrumentation and high angulation screws designed to help surgeons perform the procedure while preserving the patient’s skeletal and muscle tissue, Spinal Elements said. Beyond a smaller incision is the expectation that the streamlined integrated instrumentation will reduce procedural steps and complexity, the company added. After the procedure has taken place, the low-overhang implant is designed to minimise disruption to the patient’s nearby healthy anatomy, a feature that has been shown in studies to reduce the incidence adjacent level ossification.

Orthopaedic surgeon John Devine, professor and chief of spine surgery at Augusta University Medical Center in Augusta, USA said: “The Sapphire X system is going to allow me to secure the smallest possible anterior plate after an anterior cervical discectomy and fusion which may decrease the risk of iatrogenic adjacent segment disease that is often seen associated with longer anterior plates. Additionally, the instrumentation will allow a single step insertion of both the interbody spacer and anterior plate, improving my efficiency while decreasing the exposure needed for traditional plating systems.”

Commercial introduction of the Sapphire X system is expected in the coming months. Spinal Elements announced its MIS Ultra platform in June of this year.

“We are thrilled that Sapphire X, another organically developed MIS Ultra solution, is one step closer to clinical use and commercial introduction,” stated Jason Blain, president and CEO of Spinal Elements. “We believe Sapphire X has the potential to improve the intra-operative experience while reducing long-term adjacent level degeneration, one of the recognised unintended consequences in this application.”


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