FDA OKs Spinal Elements’ Sapphire X Anterior Cervical Fixation System

Spinal Elements, a Carlsbad, Calif.-based medical device company focused on spine surgery procedures, announced the FDA clearance of Sapphire X for anterior cervical fixation. Sapphire X is the newest product in its MIS Ultra suite of products aimed at minimizing the unintended consequences of traditional spine surgery.
 
The Sapphire X Anterior Cervical Fixation System features unique 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.
 
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.”
 
Commercial introduction of the Sapphire X system is expected in the coming months. “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 recognized unintended consequences in this application.”
 
Spinal Elements announced its MIS Ultra platform in June of this year. Traditionally, MIS procedures have been focused on the size of the incision required for access to the spine. The MIS Ultra product suite goes beyond small incisions to consider the implications of spine surgery after the procedure has taken place. The surgical instruments of the MIS Ultra platform have been designed to reduce the disruption of the patient’s skeletal and muscle tissue, and the implants have been designed to balance the loads shared between the implants and the body while not disrupting the patient’s surrounding healthy anatomy.