OrthoXel03.16.18
OrthoXel, a new orthopedic trauma company, pioneering the use of enhanced fracture fixation to stimulate callus formation with the goal to reduce healing time, has announced that following FDA 510k clearance and European CE mark approval, the first patient in Cork University Hospital Trauma Center has had the Apex Tibial Nail implanted.
The patient, a 42 year-old female, presented with a spiral mid-shaft tibial fracture and was treated by Professor James Harty, consultant orthopaedic surgeon and head of the Department of Orthopaedics at Cork University Hospital. Prof. Harty successfully completed the world’s first clinical use of the Apex Tibial Nailing System in Cork University Hospital on Saturday, March 3.
Prof. Harty explained, “It was a major milestone to use the Apex Tibial Nailing System from OrthoXel in a live trauma case. As was expected, the surgical procedure was smooth and uncomplicated and barring any extenuating circumstances, I expect the patient recovery to be full and swift.”
According to the company, the Apex Tibial Nailing system offers surgeons the greatest range of locking options of any intramedullary nail on the market, allowing tailored patient care with a simple and intuitive surgical procedure.
Professor Hannah Dailey, chief scientific officer at OrthoXel, commented, “This implant is the first of a clinical trial running at Cork University Hospital, Ireland that has been designed with an innovative approach to outcomes assessment. OrthoXel is currently seeking potential research partners to replicate or initiate a similar clinical investigation in the USA.”
According to the company, the Apex Tibial Nailing system offers surgeons the greatest range of locking options of any intramedullary nail on the market, allowing tailored patient care with a simple and intuitive surgical procedure. The Apex system’s micromotion locking mode allows controlled axial movement with exceptional torsional stability, providing the ideal conditions for callus formation. Research shows that controlled small axial movements along the length of the bone help to accelerate healing, while twisting movements slow down healing.
The Apex system has 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 also provides additional locking modes so the surgeon can customize the fixation to suit the needs of the patient, including: 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.
The patient, a 42 year-old female, presented with a spiral mid-shaft tibial fracture and was treated by Professor James Harty, consultant orthopaedic surgeon and head of the Department of Orthopaedics at Cork University Hospital. Prof. Harty successfully completed the world’s first clinical use of the Apex Tibial Nailing System in Cork University Hospital on Saturday, March 3.
Prof. Harty explained, “It was a major milestone to use the Apex Tibial Nailing System from OrthoXel in a live trauma case. As was expected, the surgical procedure was smooth and uncomplicated and barring any extenuating circumstances, I expect the patient recovery to be full and swift.”
According to the company, the Apex Tibial Nailing system offers surgeons the greatest range of locking options of any intramedullary nail on the market, allowing tailored patient care with a simple and intuitive surgical procedure.
According to the company, the Apex Tibial Nailing system offers surgeons the greatest range of locking options of any intramedullary nail on the market, allowing tailored patient care with a simple and intuitive surgical procedure. The Apex system’s micromotion locking mode allows controlled axial movement with exceptional torsional stability, providing the ideal conditions for callus formation. Research shows that controlled small axial movements along the length of the bone help to accelerate healing, while twisting movements slow down healing.
The Apex system has 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 also provides additional locking modes so the surgeon can customize the fixation to suit the needs of the patient, including: 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.
