Preclinical Evaluation of the NeVaTM Stent Retriever: Safety and Efficacy in the Swine Thrombectomy Model

摘要

Background: A novel stent retriever device with an enhanced radial force profile, enlarged offset openings, and a closed distal end has been developed. Objective: Evaluate the safety and effectiveness of the NeVa~(TM)thrombectomy device in animal model of thrombo-occlusive disease. Materials and Methods: Seven swine were used in safety and efficacy studies. Thrombo-occlusive disease was modeled using 4 emboli morphologies; 2 distinct models of autologous whole blood thrombi, plasma-enriched thrombi, and Onyx? emboli. A total of 35 vascular occlusions and retrievals were performed using emboli of variable sizes. Pre- and post-modified thrombolysis in cerebral ischemia (mTICI) scores, number of retrievals, and the presence of angiographic complications were recorded. In the safety study, a total of 6 clot retrievals were completed and the vascular territory examined grossly and harvested for histopathological evaluation. A semiquantitative vasospasm study was performed. Radial force testing was performed on NeVa~(TM)and control devices for comparison. Results: Near-full or full reperfusion (mTICI 2b/3) was achieved in 34/35 occlusions after a mean of 1.2 passes. Full reperfusion (TICI 3) was achieved in 17/17 of whole blood clot occlusions (ranging between 10 and 20 mm) after a mean of 1.06 passes. The rate of mTICI 2b/3 reperfusion was 10/11 (mean, 1.6 passes) and 5/5 (mean, 1.0 passes) for Onyx? and plasma-enriched clot emboli, respectively. Histopathological vessel injury and vasospasm scores were comparable to predicate studies. Radial force curves demonstrated increased expansive radial force and similar compressive radial force compared to predicate devices. Conclusions: Our preclinical results support the use of the NeVa~(TM)device in a clinical trial to determine if this novel design improves upon current stent retriever outcomes.