DUO Microcatheter

The DUO Microcatheter is a single-lumen, variable stiffness catheter designed for selective placement of devices and/or fluids (such as contrast media) into peripheral, coronary, and neuro vasculature during diagnostic and/or therapeutic procedures. It is a disposable, sterile, single-use device with a hydrophilic coating on the distal 80 cm, radiopaque markers for fluoroscopic visualization, and a luer hub for connection.

The DUO Microcatheter has a polymer jacket with stainless steel reinforcement and PTFE inner layer, platinum/iridium market band, and hydrophilic coating—matching the predicate. Key differences include: shaft outer diameters of 2.8F proximal/2.4F distal (vs. 2.4F/2.0F for predicate), hydrophilic coating on distal 80 cm (vs. 100 cm for predicate), effective length of 160 cm (vs. 162 cm), and a different accessory configuration (peel away introducer and steam shaping mandrel vs. rotating hemostasis valve). Shelf life is extended to 3 years versus 2 years for the predicate.

ISO 10555-1 (catheter testing including tensile strength, air/liquid leak, burst pressure, tip stiffness, corrosion); ISO 80369-7 (luer hub testing); ISO 10993 series (biocompatibility including cytotoxicity, hemolysis, thrombogenicity, sensitization, acute systemic toxicity, pyrogenicity); EN ISO 10993-7 (ethylene oxide residuals for delivery systems).

The DUO Microcatheter uses identical materials (polymer jacket with steel reinforcement and PTFE, platinum/iridium bands, hydrophilic coating), the same fundamental principle of operation (advancement over a guidewire into vasculature), and the same intended indications as the predicate Trevo Trak 21 Microcatheter. Minor dimensional variations (proximal/distal diameter, coating length, effective length, shelf life) and different accessory devices do not create new safety or effectiveness concerns, as all bench testing (dimensions, tensile strength, leak resistance, burst pressure, kink resistance, torque, trackability, tip flexibility) demonstrated comparable or equivalent performance to the predicate. Comprehensive biocompatibility testing confirmed non-cytotoxic, non-hemolytic, non-thrombogenic, and non-sensitizing properties appropriate for circulating blood contact ≤24 hours.