Introduction The currently available mechanical devices fail to achieve recanalization in as many as 20–40% of proximal arterial occlusion strokes. We now report on the preclinical evaluation of the safety and efficacy of a novel thrombectomy device designed to achieve immediate flow restoration by quickly removing clot.
Methods Four confirmatory animal studies were performed with the Trevo Device (Concentric Medical Inc, Mountain View, California, USA) in the swine (n=2) and canine (n=1) models of arterial thrombo-occlusive disease employing autologous thrombin generated thrombi. The angiographic response and the degree of device clot incorporation were evaluated. High resolution flat panel three-dimensional CT was performed to further define the in vivo device–thrombus–vessel interaction. Finally, samples of three swine vessels treated with six passes of the device were explanted for histopathological analysis.
Results A total of 16 clots of variable hardness and consistency were implanted in a variety of vascular settings, including the swine internal maxillary, lingual and forelimb arteries as well as the canine external carotid and vertebral arteries. TIMI 2–3 reperfusion was achieved in all cases immediately after device deployment. All 16 clots were retrieved after one (n=15) or two (n=1) passes with the device. Histopathological analysis demonstrated severe disruption of the intima but no hemorrhage of media or adventitia.
Conclusion Our experimental data suggest that the Trevo Device is highly effective at achieving immediate reperfusion of occluded arteries without causing any clinically significant disruption of the vascular integrity. Initial human clinical evaluations of the Trevo Device in acute ischemic stroke patients are underway.
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Competing interests RN—Concentric Medical Inc, Coaxia Inc, ev3 Neurovascular Inc, Rapid Medical Inc; EL—Boston Scientific, Micrus Endovascular, ev3, Cordis Neurovascular, Intratech Medical Ltd, Mynx/Access Closure; MG—Philips Healthcare, National Institutes of Health, Guerbet, Micrus Endovascular, Soteira Inc, Codman Neurovascular; AS—Codman/Cordis, Micrus Endovascular, ev3, Concentric Medical, Cordis, Genentech; GD—Concetric Medical Inc.