The Sapphire X anterior cervical fixation system is part of the MIS Ultra suite of products
Spinal Elements has secured FDA approval for Sapphire X anterior cervical fixation system. (Credit: Business Wire)
Medical devices maker Spinal Elements has secured approval from the US Food and Drug Administration (FDA) for its Sapphire X anterior cervical fixation system.
The Sapphire X anterior cervical fixation system is part of the MIS Ultra suite of products, which are used to minimise the unintended consequences of traditional spine surgery.
Spinal Elements’s new system is provided with an integrated instrumentation and high angulation screw that will allow surgeons to conduct the procedure while safeguarding the patient’s skeletal and muscle tissue.
The streamlined integrated instrumentation will allow to minimise procedural steps and complexity. Upon completion of the procedure, the low-overhang implant is used to eliminate disruption of the patient’s nearby healthy anatomy.
The Sapphire X system will be commercially launched in the coming months
Spinal Elements is planning to commercially introduce the Sapphire X system in the coming months.
Spinal Elements president and CEO Jason Blain said: “We are thrilled that Sapphire X, another organically developed MIS Ultra solution, is one step closer to clinical use and commercial introduction.
“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.”
In June, Spinal Elements launched its MIS Ultra platform of products and procedures, designed to minimise the unintended consequences of spine surgery.
MIS Ultra is a suite of minimally invasive integrated instrument and implantable device solutions designed to optimise spinal fixation and restoration.
Based in Carlsbad of California, Spinal Elements is engaged in the designing, development and commercialisation of a comprehensive portfolio of systems, products and technologies for spine surgery procedures.