TY - JOUR AU - Anagnostakou, Vania AU - Nogueira, Raul G AU - Epshtein, Mark AU - Gounis, Matthew J AU - Behme, Daniel AU - Ulm, Arthur AU - Gupta, Rishi PY - 2022/12/02 Y2 - 2024/03/29 TI - Preclinical safety and efficacy of the NeVa NET™: A novel thrombectomy device with integrated embolic distal protection: Preclinical safety and efficacy of the NeVa NET™ JF - Journal of Vascular and Interventional Neurology JA - JVIN VL - 14 IS - 2 SE - Original Research Article DO - UR - https://ojs.jvin.org/index.php/jvin/article/view/18 SP - 1-16 AB - <p>Background</p><p>High quality reperfusion is linked to better clinical outcomes during thrombectomy for large vessel occlusion in acute ischemic stroke. A novel stent-retriever device with an integrated microfilter for embolic distal protection has been developed to improve first pass full reperfusion.</p><p>Objective</p><p>Compare the safety and effectiveness of the NeVa NET<sup>™</sup> versus the standard stent-retriever thrombectomy devices.</p><p>Materials and methods</p><p>Radial force measurements were performed on 10 NeVa NET™ and 4 Solitaire™ 6x30mm. Animal studies involving three Yorkshire pigs were performed comparing NeVa NET™ to Solitaire™ 6x40mm and 4x40mm to assess for acute vascular injury, vasospasm and thrombogenicity during thrombectomy. A randomized comparison in a closed loop vascular model was performed to quantify first pass effect and distal emboli generated during twenty MCA thrombectomies.</p><p>Results</p><p>Radial force curves were similar between the NeVa NET™ and Solitaire™ 6x30mm. Below 2.5mm the Solitaire™ demonstrated higher radial force compared to NeVa NET™. Vasospasm scores were nearly identical after four thrombectomies in multiple similar sized swine arteries. The addition of the internal filter did not result in increased thrombogenicity in the non-heparinized swine model. In the randomized flow model study, NeVa NET™ required less passes than Solitaire™ to achieve TICI 3 reperfusion (p=0.0344). Solitaire™ generated 4-fold more clot fragments &gt;1mm in size compared to NeVa Net™ (p=0.037, Wilcoxan rank sum). For fragments between 0.2-1mm, Solitaire™ generated 91 whereas NeVa™ generated a total of 20 fragments. Overall, more clot fragments were generated during Solitaire™ as compared to NeVa NET™ thrombectomy (p=0.048).&nbsp;</p><p>Conclusions</p><p>Our pre-clinical results support the use of the NeVa NET<sup>TM</sup> device in a clinical trial to determine if this novel design improves first pass full reperfusion.&nbsp;</p> ER -