Apex Tibial Nailing System Micromotion Locking Option (Medical Device News Magazine)

An innovative new orthopaedic trauma company, OrthoXel, pioneering the use of enhanced fracture fixation to stimulate callus formation with the goal to reduce healing time, 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.

OrthoXel reports the patient is a 42 year-old female, who presented with a spiral mid-shaft tibial fracture and 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 3rd March.

Professor James Harty, Consultant Orthopaedic Surgeon, Cork University Hospital commented, “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.”

Professor Hannah Dailey, Chief Scientific Officer, OrthoXel added, “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.