Millipede System

The Millipede System is a mechanical thrombectomy device consisting of two aspiration catheters (Millipede88 and Millipede70) and an aspiration tube set. It is indicated for revascularization of patients with acute ischemic stroke caused by large vessel occlusions in the brain within 8 hours of symptom onset, for patients ineligible for or unresponsive to thrombolytic therapy.

Both aspiration catheters are single-lumen, reinforced, variable stiffness catheters with hydrophilic coatings on their distal ends, radiopaque markers, and rotating hemostasis valves. The Millipede88 has an inner diameter of 0.088 inches and length of 120 cm; the Millipede70 has a distal inner diameter of 0.070 inches and length of 136 cm. The Perfuze Aspiration Tube Set is a single flexible braided tube with rotating luer-lock and suction connectors. The subject device does not include a delivery catheter, unlike the predicate.

ISO 11135 (sterilization by ethylene oxide with sterility assurance level of 1×10⁻⁶); ISO 13485 clauses 7.3 (design controls), 8.3 (nonconforming product), and 8.5 (corrective and preventative action); 21 CFR 820 (Quality Management System Regulation).

The Millipede System has the same intended use, principle of operation (direct aspiration thrombus removal), regulatory classification (Class II, 21 CFR 870.1250, product code NRY), and materials as the Route 92 Medical HiPoint predicate device. Minor design differences (e.g., no separate delivery catheter, slightly different dimensions) do not raise new safety or effectiveness questions. Nonclinical testing (simulated use, stent-retriever compatibility, flow rate, clot retrieval, animal studies in porcine models) and the prospective MARRS clinical trial (n=180 subjects, 88.9% achieving mTICI ≥2b within 3 passes) demonstrate comparable safety and effectiveness to predicate devices.