Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set

The Millipede 070 Aspiration Catheter is a sterile, single-use device designed to remove blood clots from brain arteries in acute ischemic stroke patients. It works with a compatible aspiration pump and the Perfuze Aspiration Tube Set to revascularize patients with large vessel occlusions in specified brain arteries within 8 hours of symptom onset, for patients ineligible for or who have failed intravenous thrombolytic therapy.

The subject device has identical technological characteristics to the predicate: same 6 Fr catheter profile with 0.070 in distal inner diameter, hydrophilic coating, braid and coil reinforcement, rotating hemostasis valve, radiopaque marker, 136 cm working length, and identical materials (polymers and metals). The only change is a different sterilization cycle for the Perfuze Aspiration Tube Set component.

ISO 11135 for sterilization validation of the ethylene oxide (EO) process using the overkill method. The sterilization achieves a sterility assurance level of 1×10⁻⁶.

The subject and predicate devices share identical indications for use, operating principles (direct aspiration thrombectomy), design, materials, dimensions, and all technological characteristics. Since there are no changes to the device itself, non-clinical bench testing and biocompatibility testing were not required. The only modification is the sterilization cycle for the Perfuze Aspiration Tube Set, which was validated per ISO 11135 and does not raise different questions of safety or effectiveness. Packaging integrity testing confirmed the new sterilization process maintains sterile barrier properties, demonstrating substantial equivalence to the predicate device.