Paragon 28 launches the R3FLEX stabilization system for the anatomical repair of syndesmosis injuries of the ankle Page 1

Figure 1: R3FLEX Stabilization System and Gorilla Ankle Fracture Plating System for the treatment of an ankle fracture with syndesmosis injury. (Graphic: Business Wire)

Ankle fractures are among the most common injuries, with over 470,000 cases expected to occur in the United States by 2024.^1.2 An estimated 23% of all ankle fractures are due to an injury to the distal tibiofibular syndesmosis.³ In addition, “high ankle sprains” account for 7–15% of all ankle sprains and are defined as isolated injuries to the distal tibiofibular syndesmotic ligaments.⁴
In the United States, approximately 2 million acute ankle sprains occur each year.⁵ Syndesmotic injuries are traditionally treated surgically with cortical screws and, more recently, with flexible fixation options that assist in accurate positioning and maintenance of repositioning of the fibula in relation to the tibia.⁴

The R3FLEX stabilization system allows surgeons to precisely adjust and visualize tension during repair as needed with a simple twist of the handle. The design and functionality of the device allows surgeons to return the patient's soft tissue to a more natural anatomy, mitigating the arthritic response and minimizing the risk of hardware removal.

During preparation and implantation of the R3FLEX implant, the tibial implant rests on the inner surface of the tibia rather than the outer surface of the cortical bone. Screws and other flexible fixation products may require hardware on the outer surface of the tibial bone, which may increase the risk of injury to the saphenous nerve and great saphenous vein during preparation and implantation.⁶

The implant's innovative design also utilizes a short suture loop between the all-suture anchor in the tibia and the titanium fibula component to create a stable repair construct that is less susceptible to stretching or creep, which may be a concern for some surgeons.⁷ The fibula component contains a thermoplastic urethane bumper inside that allows micro-movements during the repair, allowing the fibula to move in a controlled manner similar to the uninjured state.