US Market Report for ACL/PCL Fixation Devices 2017 - MedCore
General Report Contents
- Market Analyses include: Unit Sales, ASPs, Market Value & Growth Trends
- Market Drivers & Limiters for each chapter segment
- Competitive Analysis for each chapter segment
- Section on recent mergers & acquisitions
In tibial fixation, the most commonly used devices are interference screws. Although interference screws have long been the standard for tibial fixation, there is a trend towards newer technologies such as intratunnel devices. One of the setbacks of using interference screws is that the graft tends to twist around the screw as it is being inserted, causing the graft to lose its native anatomical position in the joint. This problem is solved by intratunnel devices which are commonly composed of a sheath and screw system. The sheath protects the graft from moving so that it better retains its anatomical rotation. It also pushes the graft closer up against the tibial tunnel, giving more graft to bone contact, which enhances the healing of the tunnel wall. Since tibial bone tends to be less dense than femoral bone, surgeons sometimes use washers and posts as a backup to intratunnel fixation devices. They do this mainly if they feel the patient has poor bone quality, leading to weaker fixation. Overall, this segment of the market is much smaller than the interference screw and intratunnel device market, and it is also declining with the emergence of newer, stronger fixation technologies.
For the femoral side, cortical fixation devices are most commonly used. These devices flip on the cortical surface and anchor the graft to the femoral tunnel, and thus do not rely on cancellous bone for fixation. Cross-pins are the second most popular femoral fixation device and have been developed to retain the graft ligament within the bone tunnel by securing it with a pin, extending transversely through the tunnel and the ligament. Interference screws are also used for fixing soft tissue to femoral bone; however, they are not as popular for use in the femur as in the tibia since the femur is denser than the tibia. Intratunnel devices also exist for femoral fixation; however, the number of products available is more limited than for tibial fixation.
The interference screw market for both tibial and femoral fixation can be further segmented into the different types of materials that are available for these products. In 2014, four different materials for interference screws existed: first generation resorbables, second generation resorbables, non-absorbable polymers and non-resorbables.
First generation resorbables have since been losing share to newer materials, such as second generation resorbables (with a calcium-type mineral component) and non-absorbable polymers (including polyetheretherketone (PEEK) and polyester materials), that became available in late 2007. First generation resorbables are composed of materials that are absorbed by the body after surgery and eventually disappear, such as polylactic acid (PLA/PLLA) or polylactic-co-glycolic acid (PLGA). From this point forward, first generation resorbables will be referred to as the PLA resorbables.
Second generation resorbables contain a synthetic copolymer of tricalcium phosphate (TCP) or hydroxyapatite (HAP) and as such are most commonly referred to as biocomposites. These screws are an evolution of the standard PLA polymer because the calcium-type mineral component blended into them encourages bone in growth during device absorption by the body. Due to the fact that a portion of the PLA material is removed, they also produce less adverse soft tissue reactions.
Non-resorbable polymer interference screws are most commonly composed of PEEK materials and will be referred to as the PEEK segment in this chapter. PEEK material is gaining acceptance in the medical community as it does not produce an adverse inflammatory tissue reaction in manner of PLA resorbable interference screws. It also has mechanical properties that are similar to bone, making it more biocompatible than metal.
Non-resorbables include devices made of metallic materials, of which titanium is the most commonly used. Historically, most devices were made from metal; however, since the introduction of more biocompatible materials, the use of metal interference screws has been steadily declining.
There are several different graft options that can be used for anterior cruciate ligament/posterior cruciate ligament (ACL/PCL) reconstruction procedures. One of the most traditional methods is the use of bone-to-bone (BTB) grafts, where the ends of the graft contain bone that is then fixed to the femoral and tibial tunnels. The other option for surgeons is to use soft tissue grafts (either hamstring or quadriceps tendon) that require the soft tissue to be fixed to the tibial and femoral bone. For procedures using BTB grafts, only interference screws are used for anchoring the tendon or ligament of the graft to the bone. In contrast, for procedures that use soft tissue grafts, a variety of other devices are available to fixate the graft to the femoral and tibial tunnels. For every ACL/PCL repair procedure, both the tibia and femur are involved in fixating the new tissue between these two bones. Fixation to the tibia differs from femoral fixation with respect to the devices used and thus the ACL/PCL fixation market is composed of the tibial fixation and femoral fixation segments.