Background The currently available mechanical devices fail to achieve recanalization in as many as 20–40% of proximal arterial occlusion strokes.
Objective The preclinical evaluation of the safety and efficacy of a novel thrombectomy device designed to achieve immediate flow restoration by quickly removing clot is reported.
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. Thrombolysis in Myocardial Infarction (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 The experimental data suggest that the Trevo device is highly effective at achieving immediate reperfusion of occluded arteries without causing any clinically significant disruption of vascular integrity.
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Disclosures Raul G. Nogueira is a member of the Scientific Advisory Boards (SAB) for Concentric Medical Inc., ev3 Neurovascular Inc., CoAxia Inc., and Rapid Medical, Inc. Elad I Levy receives research grant support, other research support (devices), and honoraria from Boston Scientific and research support from Micrus Endovascular and ev3; has ownership interests in Intratech Medical Ltd. and Mynx/Access Closure; serves as a consultant on the SAB to Cordis Neurovascular; serves as a consultant per project and/or per hour for Micrus Endovascular, ev3, and TheraSyn Sensors, Inc; and receives fees for carotid stent training from Abbott Vascular and ev3. Dr Levy receives no consulting salary arrangements. All consulting is per project and/or per hour. Matthew J. Gounis serves as a consultant for Micrus Endovascular, Codman Neurovascular, and Soteira Inc. He also currently receives research support from Philips Healthcare, Guerbet, and the National Institutes of Health. Adnan H Siddiqui has received a research grant from the University at Buffalo, is a consultant to Codman/Cordis, Concentric Medical, ev3, and Micrus Endovascular, serves on speakers' bureaus for Cordis and Genentech, and has received honoraria from Genentech, Neocure, an American Association of Neurological Surgeons' course, and an Emergency Medicine Conference, and from Cordis for training other neurointerventionists. Gary Duckwiler has stock ownership in Concentric Medical Inc.
Funding Concentric Medical, Inc. funded this project; however, all the performance data analysis and interpretation was performed by the authors, independent of Concentric Medical's input or interpretation.
Competing interests Yes.
Provenance and peer review Not commissioned; externally peer reviewed.
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