APRO 45 Catheter and Alembic Aspiration Tubing

The APRO 45 Catheter is a single-lumen, reinforced aspiration catheter designed to remove blood clots from occluded intracranial vessels in patients with acute ischemic stroke. Used with an aspiration pump and tubing, it is advanced through the vasculature under fluoroscopic guidance to retrieve thrombus from large vessels (internal carotid, middle cerebral M1/M2, basilar, and vertebral arteries) within 8 hours of symptom onset in patients ineligible for or who failed thrombolytic therapy.

The APRO 45 differs from the predicate APRO 55 primarily in dimensions: smaller outer diameters (0.060 inch proximal vs. 0.066 inch; 0.058 inch distal vs. 0.066 inch) and inner diameter (0.045 inch vs. 0.055 inch), plus different effective lengths (115, 125, 146, 160 cm vs. 125, 137 cm) and shorter coated length (60 cm vs. 90, 102 cm). The liner material differs (PTFE/Pebax composite vs. PTFE/Tecoflex composite), extrusion materials differ (polyether block amide vs. thermoplastic polyurethanes), and shelf life is extended to 1 year versus 6 months. All other materials, design principles, sterilization method, and accessories remain the same.

ISO 10555-1 (catheter performance and corrosion), ISO 80369-7 (hub compatibility), ISO 11135 (ethylene oxide sterilization to 1×10⁻⁶ SAL), ISO 10993-1 (biocompatibility evaluation). Biocompatibility testing included sensitization (guinea pig maximization), irritation, cytotoxicity (MEM elution), hemolysis (indirect and direct), thrombogenicity (PTT, platelet count, surface morphology), complement activation, acute systemic toxicity, and pyrogenicity.

The APRO 45 is substantially equivalent because it uses identical materials, design concept, and operating principles as the APRO 55 predicate—both aspirate thrombus using the same mechanism with predicate-specified aspiration pump performance. Non-clinical bench testing confirmed the APRO 45 meets all functional specifications including vacuum integrity, kink resistance, burst pressure, delivery/retrieval force, and simulated clot retrieval in anatomical models. Biocompatibility testing demonstrated safety equivalent to the predicate despite material changes (PTFE/Pebax liner and polyether block amide extrusions), with no new safety or effectiveness concerns. The dimensional differences do not alter the fundamental safety or function—the smaller profile and extended shelf life represent refinements, not fundamental design changes, and all performance testing compared to or equaled the predicate device.