Purpose To evaluate the performance of a new large lumen//hyper flexible intracranial access and aspiration device (ReFlexTM, Reverse Medical, Irvine, California, USA) for endovascular use in a swine thrombo-embolic model, cadaver model, and initial clinical settings, and to compare its efficacy to other available devices.
Method We investigated the use of Reflex 058 and 072 devices for endovascular access and focal thrombus aspiration treatment in a swine model, cadaver model, and initial clinical settings. These new devices employ a combination of Nitinol and a special tertiary polymeric composite which results in a larger lumen, thin walled device, possessing extreme flexibility and kink resistance. 10 carotid artery branches (lingual, maxillary, or ascending pharyngeal) in swine were prepared with prophylactic papaverine and occluded with radiopacified blood thrombi. Once the occlusion was confirmed, ReFlex or a control device was advanced proximal of the target thrombi. Only localized aspiration was applied through the ReFlex or control device. No flow arresting means were utilized. Parameters collected for this assessment study were the ability to access target vessels, TICI score, number of aspiration attempts, % clot retrieved, and thrombus fragmentation and/or thrombus loss at the tip of the device. Since the swine model is much less tortuous than humans, a perfused cadaver model was utilized to confirm intracranial accessibility performance against control devices. Initial clinical evaluations were performed in conjunction with commercially available mechanical thrombectomy devices.
Result We found slightly better TICI scores, and % clot retrieved with ReFlex, and superiority over the control devices in the ability access distal anatomy within both the swine and cadaver models. No vessel dissections or device failures were encountered during this study. Additionally, histopathologic safety testing was conducted, and revealed lower intimal damage compared to the control devices. Lastly, since ReFlex device has a slightly larger lumen over the control devices, the ability to injection contrast was noticeable easier. Initial clinical use demonstrated the devices ability to aspirate thrombus in conjunction with mechanical thrombectomy devices. Initial clinical use demonstrated aspiration thrombus capabilities from the middle cerebral artery territories.
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Disclosures S Tateshima: Reverse Medical. V Mendes Pereira: Reverse Medical. D Lopez: Reverse Medical.