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New devices designed to provide more anatomic reconstruction.
Mitek Sports Medicine released two new systems for anterior cruciate ligament (ACL) reconstruction during a recent meeting of the Arthroscopy Association of North America. Mitek’s Rigidfix Curve Cross Pin System, which the company calls “the first of its kind,” is designed specifically for use with the anteromedial portal approach to enable a more anatomic ACL reconstruction. The company also launched the Rigidloop Cortical Fixation System, which when used with the company’s Intrafix ACL Tibial Fastener System, provides surgeons with a total procedural solution for anatomic soft-tissue ACL reconstructions, according to Mitek officials. According to the U.S. Centers for Disease Control and Prevention, ACL injury affects as many as 250,000 individuals in the United States each year. The Rigidfix Curve System is in limited release in the United States and full release in Europe, the Middle East and Africa. In addition, the company announced that two new sizes of Milagro Advance Interference Screws (30 and 35 millimeters) were added to Mitek Sports Medicine’s portfolio of knee solutions for soft-tissue and bone-patellar tendon-bone reconstruction. Using the AM portal approach, the Rigidfix Curve System enables precise placement of two cross pins in the femoral tunnel. The cross pins provide strong fixation and the close-to-aperture fixation minimizes intratunnel graft micromotion (small movements of the graft inside the femoral tunnel) that may cause tunnel widening, Mitek officials noted. The two cross pins create a compression fit that enhances 360-degree graft to bone contact. The design of Rigidfix Curve is based on the original Rigidfix Cross Pin System, which has been used for ACL reconstruction through a transtibial approach for more than 10 years. “An anteromedial approach may provide a more anatomic placement of the graft and greater rotational stability of the knee, compared to transtibial drilling,” said Marc R. Labbé, M.D., clinical assistant professor, Department of Orthopedic Surgery, Baylor College of Medicine. “The Rigidfix Curve System provides a strong, rigid fixation and has features that enhance precision and ease of use.” According to the company, the Rigidloop System offers a strong, easy-to-use solution for soft tissue ACL reconstructions. The implant consists of a titanium button that comes pre-loaded with a braided suture loop and offers “excellent pull-out strength.” The new device is available in sizes 15-60 millimeters in 5-millimeter increments, as well as an extra-large button for femoral tunnels greater than 6 millimeter in diameter. Designed with simplicity in mind, the system includes an innovative variable depth gauge that calculates total transosseous length, amount of graft in tunnel, socket reaming depth and implant size. When used in combination with Mitek Sports Medicine’s Intrafix ACL Tibial Fastener System, the Rigidloop System provides a complete anatomic soft tissue ACL reconstruction that the company claims consists of the strongest cortical device (compared to Endobutton) and strongest, clinically proven tibial device. “Our portfolio of procedural solutions in orthopedic sports medicine continues to grow as we respond to the clinical needs of patients and healthcare professionals throughout the world,” said Ian Lawson, worldwide president, Mitek Sports Medicine. “Our two new ACL systems were designed to accommodate surgeons’ need for strong fixation, procedural simplicity, reproducibility and more anatomic reconstruction achieved through the AM portal technique.” Mitek Sports Medicine is part of the DePuy Synthes Companies of Johnson & Johnson.
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