Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set

The Route 92 Medical HiPoint Reperfusion System is an aspiration catheter device used to remove blood clots from brain arteries in patients with acute ischemic stroke. It is indicated for revascularization of patients with large vessel occlusions in the internal carotid artery or middle cerebral artery M1 segment within 8 hours of symptom onset, for patients ineligible for or who failed thrombolytic therapy.

The device consists of a single-lumen, coil-reinforced polymer aspiration catheter with a proximal control wire and hydrophilic coating, paired with a variable stiffness delivery catheter. Key dimensional differences from the predicate include inner diameters of 0.088" (88 model) or 0.070" (70 model) versus the predicate's 0.074"-0.071", and longer lengths of 142-143 cm versus the predicate's 115-150 cm.

Testing per ISO 11135 (sterility assurance), ISO 80369-7:2021 (Luer integrity), ISO 10555-1:2013 (air leakage, liquid leakage, static burst), and ISO 10555-1:2013 Annex D and C for various catheter performance characteristics.

The device has identical intended use, same anatomical site (neurovasculature), same user population (trained physicians), and same method of action (aspiration-based thrombectomy) as the predicate AXS Vecta system. Patient-contacting materials are unchanged from reference devices already cleared. Clinical trial data (SUMMIT MAX) demonstrated non-inferiority on the primary effectiveness endpoint (77.5% vs 50.6% revascularization) and primary safety endpoint (3.6% vs 2.7% symptomatic ICH), with performance testing confirming device suitability for intended use.