APRO 70 Swift Catheter and Alembic Aspiration Tubing

The APRO 70 Swift Catheter is a single-lumen, braid and coil reinforced catheter designed to remove blood clots from the brain using aspiration. It is used to treat acute ischemic stroke caused by large vessel blockage in the brain within 8 hours of symptom onset in patients who cannot receive or have failed thrombolytic drugs. The Alembic Aspiration Tubing connects the catheter to an aspiration pump.

The subject device has the same materials, dimensions, and operating principles as the predicate APRO 55 Catheter. The main dimensional difference is that the APRO 70 Swift has a proximal outer diameter of 0.066 inch and inner diameter of 0.055 inch, versus the APRO 55's identical dimensions. The APRO 70 Swift offers available lengths of 125, 132, and 135 cm with a 1-year shelf life, compared to the predicate's 125 and 137 cm lengths with 6-month shelf life.

ISO 10555-1 (catheter vacuum integrity and hub leakage), ISO 10993-1 (biocompatibility evaluation), EN ISO 80369-7 (hub compatibility), ISO 11135 (ethylene oxide sterilization), and ISO 10555 series for various mechanical performance tests including burst pressure, tensile strength, and kink resistance.

The APRO 70 Swift is substantially equivalent to the APRO 55 predicate because both devices share identical regulatory classification, indications for use, materials (nylon hub, cyanoacrylate adhesive, stainless steel braid/coil, PTFE liner, platinum/iridium marker), design concept, and fundamental aspiration-based operating principles. Non-clinical bench testing demonstrated comparable performance between the subject and predicate devices across critical parameters including particulate generation, vacuum integrity, kink resistance, and delivery/retrieval forces. The technological differences (outer diameter, lengths, shelf life) do not introduce new safety or effectiveness concerns and performance testing confirms the device meets predefined specifications.