Safety and Efficacy Evaluation of Aspiration Thrombectomy With Large Bore Catheters in a Porcine Model

Objective: Thrombectomy with aspiration catheters has shown to be effective for treatment of intracranial large vessel occlusion (LVO). We present preclinical evaluation of the safety and efficacy of React68 and React71 (Medtronic PLC, Irvine, CA) catheters in animal models of LVO.

Methods: In vivo evaluation of catheter safety was performed in superficial cervical, internal maxillary, and renal arteries in a porcine model with or without clot (LVO). Animals were survived for 3 days and 30 days. Angiographic outcomes, usability, and histological parameters were compared for treatment with React68, React71, and ACE68 (Penumbra, Alameda, CA) catheters.

Results: The in vivo angiographic analysis in a porcine thrombectomy LVO model demonstrated that there was no statistically significant difference in the rate of Thrombolysis in Cerebral Infarction scale 2b/3 recanalization between React68, React71, and ACE68 catheters. There were no physical or neurologic deficits in any of the treated animals throughout the survival period. Histologic analysis showed statistically non-inferior safety profile of React68 and React71 catheters relative to ACE68 catheters, with minimal but similar mild internal elastic lamina disruption and smooth muscle loss, but a lack of inflammation, fibrin deposits, and changes in the adventitia at both time points examined.

Conclusions: React68 and React71 aspiration catheters have an excellent safety, efficacy, and usability profile in animal models of LVO.