Orthofix Announces Global Commercial Launch of the TrueLok Elevate Transverse Bone Transport System
LEWISVILLE, Texas–(BUSINESS WIRE)– Orthofix Medical Inc. (NASDAQ:OFIX), a leading global medical technology company, today announced the global commercial launch of the TrueLok™ Elevate Transverse Bone Transport (TBT) System. TrueLok Elevate represents the first commercially available device in the U.S. with a patented design for use in the TBT procedure to provide a limb preservation treatment option for addressing bony or soft tissue deformities or defects, such as diabetic ulcers.
“I have been using the TrueLok Elevate System in my practice to treat patients with ulcers and other ischemic conditions and am pleased by the results I have observed so far,” said Victor Anciano, M.D., a foot and ankle surgeon in Louisville, KY, who has used TrueLok Elevate during the limited market release. “The system offers a reproducible, streamlined surgical approach as well as easy adjustability for the patient. I look forward to continuing to integrate this product into my practice to best treat patients who are at risk of losing their limb.”
Diabetes mellitus is projected to affect 11% of the global population (700 million people) by 2045.¹ According to the American Diabetes Association, over 160,000 amputations occur each year in the U.S. as a result of diabetic-related complications, representing a sizable market opportunity of approximately $1.2 billion.² In addition, published studies have shown that patients with diabetic foot ulcers who receive an amputation have a five-year mortality rate of 57% and are burdened with lifetime healthcare costs of just over $640,000 for care directly related to their amputation.³,⁴ Therefore, TrueLok Elevate offers the potential to be a limb- and cost-saving device for a rapidly-growing patient population.
“The success of the TrueLok Elevate System during the limited market release advances our strategy to become the leading limb reconstruction company in the market, and in particular, expands our presence in the growing diabetic wound market with an innovative solution designed to address a challenging patient population and potentially reduce the burden of complications associated with soft tissue defects including ulcers,” said Patrick Fisher, President of Global Orthopedics for Orthofix. “We are committed to redefining the category of limb reconstruction through further innovation to ensure that our unique portfolio of industry-leading products continues to empower surgeons to excel in limb preservation, extremity deformity correction, limb lengthening and complex fracture management.”
The TrueLok Elevate System represents the latest addition to Orthofix’s flagship product line, the TrueLok family of multiplanar external fixators, including the TrueLok EVO and TL-HEX™ ring fixation systems. Since receiving FDA clearance and CE registration earlier this year, over 130 TrueLok Elevate procedures have been completed globally under a limited market release.
For indications, contraindications, warnings, precautions, potential adverse effects and patient counseling information, see the Instructions for Use or contact your local representative. Additional information about Orthofix’s full line of orthopedic solutions is available on Orthofix.com.
References:
- Maguire, B. “Europe’s amputation crisis, diabetes experts call for urgent new screening programs.” Euractiv’s Advocacy Lab May 1, 2024
- https://diabetes.org/advocacy/amputation-prevention-alliance
- Vuorlaakso, M et al. “Major Amputation Profoundly Increases Mortality in Patients With Diabetic Foot Infection.” Frontiers in Surgery vol. 8 655902. 30 Apr. 2021, doi:10.3389/fsurg.2021.655902
- Palli, S et al. “Impact of a Limb Salvage Program on the Economic Burden of Amputation in the United States.” Value in Health vol. 19(3):A45. May 2016, doi:10.1016/j.jval.2016.03.098