Orthofix Medical has secured the US Food and Drug Administration (FDA) 510(k) approval and the European CE mark for its TrueLok Elevate transverse bone transport (TBT) system.
TrueLok Elevate system is designed to provide limb preservation treatment for bony or soft tissue deformities, including diabetic foot ulcers.
The bone transport system aims to address the high incidence of amputations due to diabetic complications.
TrueLok Elevate is said to be the first dedicated TBT system to receive FDA approval and is currently commercialised in a limited market release in the US and selected international markets.
Orthofix global orthopaedics president Patrick Fisher said: “The introduction of the TrueLok Elevate system is a pivotal milestone in demonstrating our commitment to leading growth in the limb reconstruction market.
“Within our orthopaedics business, we are focusing on providing innovative solutions that spans four pillars: Limb Preservation, Extremity Deformity Correction, Limb Lengthening, and Complex Fracture Management to aid surgeons in managing patients with complex limb reconstruction needs.”
According to Orthofix, TrueLok Elevate has the potential to be a life-saving, limb-preserving, and cost-effective solution for this patient demographic.
The TBT system is part of the medical technology company’s TrueLok family, which includes the TrueLok EVO and TL-HEX ring fixation systems.
The first patient cases in Europe were performed in the UK and Germany.
Valley Foot and Ankle Specialty Providers podiatric foot and ankle surgeon Emmy Oji is one of the first surgeons to use the TrueLok Elevate system on a patient.
Emmy Oji said: “Transverse bone transport with TrueLok Elevate now enables surgeons to effectively address challenging conditions in a patient’s extremity by allowing for an efficient and reproducible method to create a bone segment in the tibia that can then be gradually distracted over a period of several days.
“Clinical publications have shown this approach improves blood circulation to the affected limb and promotes wound healing in diabetic foot, potentially reducing the need for amputation.”
Last year, Orthofix received the US FDA 510(k) approval for its Fitbone transport and lengthening system and announced the first US implant of its orthopaedic device.
The first US implant was performed by Limb Restoration and Lengthening Program director, orthopaedic surgeon David Frumberg.
