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

Interventional Neurology
Arthur J UlmRaul G Nogueira

Abstract

A novel stent retriever device with an enhanced radial force profile, enlarged offset openings, and a closed distal end has been developed. Evaluate the safety and effectiveness of the NeVaTM thrombectomy device in animal model of thrombo-occlusive disease. 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 NeVaTM and control devices for comparison. 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...Continue Reading

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Citations

Jul 4, 2020·Interventional Neuroradiology : Journal of Peritherapeutic Neuroradiology, Surgical Procedures and Related Neurosciences·Cetin K AkpinarSemih Giray
Mar 6, 2019·Toxicologic Pathology·Taylor A Spangler, Scott A Katzman

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