Paragon 28, Inc, is pleased to announce the launch of the R3FLEX Stabilization System, which is designed to restore stability to the ankle syndesmosis after injury from an ankle fracture or high ankle sprain.
Ankle fractures are one of the most common injuries with over 470,000 predicted in 2024 in the US. Injury to the distal tibiofibular syndesmosis is estimated to occur in 23% of ankle fractures. Additionally, “high ankle sprains” encompass 7-15% of all ankle sprains, and are defined as an isolated injury of the distal tibiofibular syndesmotic ligaments. The incidence of acute ankle sprains in the United States is approximately 2 million per year. Syndesmotic injuries are traditionally treated surgically with cortical screws and more recently with flexible fixation options, which assist with accurate positioning and maintenance of reduction of the fibula relative to the tibia.
The R3FLEX™ Stabilization System gives surgeons the ability to precisely adjust and visualize tension during the repair as needed with a simple turn of the handle. The design and functionality of the device allows surgeons to restore patients’ soft tissue to a more natural anatomy, helping to mitigate arthritic response and minimize the risk of hardware removal.
During preparation and implantation of the R3FLEX™ Implant, the tibial implant rests on the internal surface of the tibia rather than external to the cortical bone. Screws and other flexible fixation products may require hardware on the external surface of the tibial bone, which may increase the risk of injury to the saphenous nerve and great saphenous vein during preparation and implantation.
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The implant’s innovative design also utilizes a short suture loop between the all-suture anchor in the tibia and the titanium fibular component to create a strong repair construct that is less susceptible to elongation or creep that may cause concern for some surgeons. The fibular component contains a thermoplastic urethane bumper inside to allow for micromotion in the repair so the fibula can move in a controlled manner similar to its uninjured state.
The R3FLEX™ Stabilization System is delivered to surgeons in a single sterile kit that includes both the implants and instruments to simplify surgical workflow and inventory management.
Paragon 28’s CEO, Albert DaCosta, commented, “The R3FLEX Stabilization System is the crown jewel of our syndesmotic injury repair portfolio with novel features that give surgeons the ability, for the first time, to precisely adjust and visualize tension during a repair with the simple turn of the handle. Dynamic tensioning is incredibly important, and we believe it will help mitigate arthritic response, which is a primary complication following these types of ankle fractures.”
Surgeon Designer Lauren Geaney, MD, commented, “R3FLEX is an exciting solution to syndesmotic fixation: providing improved and reliable stability while simultaneously allowing forgiveness to malreduction. Additionally, the fixation on the lateral tibial cortex decreases potential for interference with medial tibial fracture hardware or injury to medial distal tibial neurovasculature.”
SOURCE: Businesswire