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FDA Clears Spinal Elements’s Anterior Cervical Fixation System

The device is part of the Carlsbad, CA-based company’s MIS Ultra Suite of products.

Spinal Elements has obtained a nod from FDA for its Sapphire X for anterior cervical fixation. The technology is the newest device in its MIS Ultra Suite of products aimed at minimizing the unintended consequences of traditional spine surgery.

The Carlsbad, CA-based company said its commercial introduction of the Sapphire X system is expected in the coming months. 

The Sapphire X Anterior Cervical Fixation System has integrated instrumentation and high angulation screws designed to help surgeons perform the procedure while preserving the patient’s skeletal and muscle tissue. Beyond a smaller incision is the expectation that the streamlined integrated instrumentation will reduce procedural steps and complexity. After the procedure has taken place, the low-overhang implant is designed to minimize disruption to the patient’s nearby healthy anatomy, a feature that has been shown in studies to reduce the incidence adjacent level ossification.

In a release, orthopedic surgeon John Devine, M.D., Professor and Chief of Spine Surgery at Augusta University Medical Center in Augusta, GA 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.”

 

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