The company made that bold claim in a January 16, 2018 company press release announcing the notification of U.S. FDA 510(k) clearance and European CE mark approval for its Apex Tibial Nailing System.
According to the announcement, the system’s “revolutionary micromotion locking mode allows controlled axial movement with exceptional torsional stability, providing the ideal conditions for callus formation.” The company says research shows that controlled small axial movements along the length of the bone “help to accelerate healing, while twisting movements slow down healing.”
“No other intramedullary nail currently on the market in the U.S. or the EU [European Union] gives surgeons the freedom to choose this ideal combination of flexibility and stability for their patients.”
Furthermore, says the company, the system allows surgeons to customize the fixation due to the locking modes. This is due to a “unique design featuring the first-ever implementation of this controlled micromotion in an intramedullary nailing platform, all with no changes to the established evidence-based reamed insertion technique.”
The Apex system provides additional locking modes, so the surgeon can customize the fixation. The features include: “standard cross-locking, true rigid fixation with multiple proximal screw clamping to generate a substantially rigid construct, and dynamization locking with unparalleled built-in torsional stability. The state of the art reusable implantation kit allows fast and reliable nail implantation in any locking mode.”
OrthoXEL’s Chief Medical Officer, Professor James Harty, M.D., said the company has worked closely with the clinical research Facility in University College Cork and other agencies within the Health Service Executive (HSE), “Such that we are now in a position to commence implanting this unique nailing technology in patients at Cork University Hospital (CUH). We have already completed the control arm of the data analysis and look forward to publishing data in 2018.”
The basic R&D and proof of principle for the system was completed in Cork Institute of Technology’s MEDIC center over a five-year period.
The organically Irish company was founded in 2014 and claims to be the only orthopedic trauma company, “focused exclusively on improving patient outcomes through enhanced fixation to stimulate callus formation, with the aim of reducing healing time when OrthoXel intramedullary nails are implanted.”
The nailing system is patent protected and the first technology the company says it will commercialize for treatment of tibial fractures. Next to come is a device for femoral fractures.
Source: OrthoXel DAC