Orthofix Earns FDA, EU Nods for Transverse Bone Transport System

Orthofix has obtained U.S. Food and Drug Administration (FDA) and CE mark clearance for its TrueLok Elevate transverse bone transport (TBT) system.

TrueLok Elevate is a limb preservation treatment option to address bony or soft tissue deformities and defects like diabetic foot ulcers and nonhealing or deep tissue wounds. It’s the first dedicated system for TBT to win an FDA nod, according to Orthofix.

The TBT system could not only be a limb and cost-saving device, the company said, but a life-saving solution for a challenging patient population. According to the American Diabetes Association, more than 160,000 amputations happen annually in the U.S. due to diabetic-related complications.

TrueLok Elevate is the latest in Orthofix’s flagship product line, the TrueLok family of multiplanar external fixators. These include the TrueLok EVO and TL-HEX ring fixation systems.

Dr. Emmy Oji, a podiatric foot and ankle surgeon at Valley Foot and Ankle Specialty Providers, was among the first surgeons to apply the system to a patient. Dr. Oji said it allows for an efficient and reproducible method to create a bone segment in the tibia that can be gradually distracted over 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,” Dr. Oji told the press.

TrueLok Elevate is undergoing limited market release in the U.S. and select international markets.

“The introduction of the TrueLok Elevate system is a pivotal milestone in demonstrating our commitment to leading growth in the limb reconstruction market,” said Patrick Fisher, President of Global Orthopedics for Orthofix. “Within our orthopedics 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.”