Paragon 28 Launches R3ACT™ Stabilization System Designed to Facilitate Multi-Staged Healing of Acute and Chronic Syndesmotic Injuries
ENGLEWOOD, Colo., April 15, 2022 — Paragon 28, Inc. (NYSE: FNA) (“PARAGON”), is pleased to announce the launch of its R3ACT™ Stabilization System designed to provide a simple solution that allows for multi-stage soft tissue healing following acute or chronic syndesmotic injury.
Paragon 28 Chief Executive Officer and Co-Founder Albert DaCosta commented, “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.”
The implant is initially rigid to allow the syndesmosis to heal during the crucial early stages following surgery. Once a patient begins to weight-bear, the tibial and fibular components of the implant disengage safely within the clear space, where an internal pre-tensioned suture loop will engage to allow for dynamic motion. The pre-tensioned suture loop and Thermoplastic polyurethane (TPU) bumpers combine to allow for diastatic motion and fibular rotation in a semi-constrained fashion.
Cyclic loading data at 300,000 cycles demonstrated improved results for the R3ACT™ Stabilization System in limiting displacement versus two separate suture constructs at a clinically significant load.1 Over 300,000 cycles, R3ACT™ exhibited displacement of less than 3.5 mm (within functional range of displacement at the joint for native function) whereas both suture constructs fell outside this range.1
Lauren Geaney, MD, a R3ACT™ design surgeon, said, “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. Furthermore, the short working length of the pre-tensioned suture loop along with the bumper provide more controlled motion and less creep than other flexible devices making this an exciting new option for more optimal syndesmotic repair.”
The addition of the R3ACT™ Stabilization System bolsters Paragon 28’s ankle fracture and syndesmotic product offering, which includes the Gorilla® Ankle Fracture Plating System, Gorilla® Pilon Plating System, Mini-Monster® Screw System, and R3LEASE™ Stabilization System. With this comprehensive portfolio, Paragon 28 provides its customers a broad array of innovative solutions for fracture fixation and soft tissue stabilization.
Paragon 28® is grateful for the significant contributions that John Kwon, MD, Lauren Geaney, MD, Lewis Freed, DPM, and Chris Zingas, MD made in the design of this system.
About Paragon 28, Inc.
Based in Englewood, Colo., Paragon 28®, is a leading medical device company exclusively focused on the foot and ankle orthopedic market and is dedicated to improving patient lives. From the onset, Paragon 28® has provided innovative orthopedic solutions, procedural approaches and instrumentation that cover a wide range of foot and ankle ailments including fracture fixation, hallux valgus (bunions), hammertoe, ankle, progressive collapsing foot deformity (PCFD) or flatfoot, charcot foot and orthobiologics. The company designs products with both the patient and surgeon in mind, with the goal of improving outcomes, reducing ailment recurrence and complication rates, and making the procedures simpler, consistent, and reproducible.
1. Performance Analysis of Dynamic Syndesmosis Repair Strategies in Cyclic Loading. Paragon 28 Research and Development.