Paragon 28 today launched its R3Act stabilization system for acute or chronic syndesmotic ankle injuries.
Englewood, California-based Paragon 28 designed the stabilization system as rigid to allow the syndesmosis to heal during the early stages post-operation. The tibial and fibular components are designed to disengage safely within the clear space once a patient begins to bear weight on the ankle. R3Act also has a pre-tensioned suture loop and thermoplastic polyurethane (TPU) bumpers that allow for diastatic motion and fibular rotation.
“As we continue to learn about syndesmotic injury and repair, it has become evident that there are benefits to both rigid and flexible fixation. The new R3Act stabilization system combines all of the benefits of both options. The early rigidity allows improved primary healing while the suture loop and bumper concept capitalize on the malreduction forgiveness afforded by more flexible fixation,” Lauren Geaney, an R3Act design surgeon, said in a news release. “Furthermore, the short working length of the pre-tensioned suture loop along with the bumper provides more controlled motion and less creep than other flexible devices making this an exciting new option for more optimal syndesmotic repair.”
Data from the device has shown cyclic loading data at 300,000 cycles that demonstrated improved results for the R3Act stabilization system in limiting displacement versus two separate suture constructs at a clinically-significant load, according to the company. After over 300,000 cycles, Paragon 28’s ankle stabilization device showed displacement of less than 3.5 mm whereas both suture constructs fell outside the range.
“Syndesmotic stabilization has been a journey to understand and more importantly to replicate. We are excited to have developed a product that we believe addresses the complex needs of this indication and mimics not only the dynamic environment of the syndesmosis but also transitions the function of stabilization to best match the healing phases of the soft tissues,” CEO Albert DaCosta said.