APRO 45 Catheter

The APRO 45 Catheter is a single-lumen, braid and coil reinforced catheter designed to facilitate insertion and guidance of interventional devices into peripheral and neurovascular blood vessels. It features a hydrophilic coating on the distal segment, a radiopaque marker for fluoroscopic visualization, and is provided sterile and single-use with an introducer sheath.

The APRO 45 Catheter is smaller than the predicate (0.045 inch inner diameter vs. 0.055 inch; 0.060 inch proximal outer diameter vs. 0.066 inch). It uses a PTFE/Pebax composite liner instead of PTFE/Tecoflex, polyether block amide extrusions instead of thermoplastic polyurethanes, offers multiple effective lengths (115–160 cm vs. 125–137 cm), and has an extended 1-year shelf life versus 6 months. Core design elements—hub, adhesive, braid/coil, marker band, coating, tip shape, sterilization method, and accessories—remain identical to the predicate APRO 55 Catheter.

ISO 10555-1 (catheters—sterility, burst pressure, liquid leakage, corrosion resistance); ISO 80369-7 (small-bore connectors); ISO 11135 (ethylene oxide sterilization and sterility assurance level validation); ISO 10993-1 (biocompatibility evaluation and risk management).

The APRO 45 differs from the predicate primarily in dimensional scaling and minor material substitutions in the liner and extrusion layers. All bench performance tests—including kink resistance, torque strength, burst pressure, tensile strength, delivery/retrieval forces, and simulated use with stent retrievers—met acceptance criteria comparable to or equal to the predicate. Biocompatibility testing confirmed non-sensitizing, non-irritant, non-cytotoxic, and non-thrombogenic properties. These dimensional and material changes do not alter the fundamental operating principle (over-the-wire catheterization for device guidance and retrieval) or intended use, and the smaller lumen is a predictable consequence of the reduced diameter that does not introduce new safety concerns.