Paragon 28 Rolls Out R3FLEX Stabilization System

Paragon 28 has launched the R3FLEX stabilization system, which aims to restore ankle syndesmosis stability after an ankle fracture or high ankle sprain.
 
Syndesmotic injuries are typically treated with cortical screws and, more recently, flexible fixation options that help accurately position and maintain reduction of the fibula relative to the tibia.
 
R3FLEX allows precise adjustment and visualization of tension during repair, as needed, with a turn of the handle, the company said. The device’s design and functionality lets soft tissue be restored to a more natural anatomy, which can help mitigate arthritic response and reduce risk of hardware removal.
 
During R3FLEX preparation and implantation, the tibial implant rests on its internal surface, instead of the cortical bone’s external surface. The implant also features a short suture loop between the all-suture anchor in the tibia and titanium fibular component. This creates a strong repair construct that’s less susceptible to elongation or creep.
 
The fibular component has a thermoplastic urethane bumper inside to allow micromotion in the repair. That way, the tibia can move in an uncontrolled manner to its uninjured state.

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“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,” said Albert DaCosta, Paragon 28’s CEO. “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.”
 
“R3FLEX is an exciting solution to syndesmotic fixation: providing improved and reliable stability while simultaneously allowing forgiveness to malreduction,” added R3FLEX surgeon designer Lauren Geaney, MD. “Additionally, the fixation on the lateral tibial cortex decreases potential for interference with medial tibial fracture hardware or injury to medial distal tibial neurovasculature.”