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
References
Sep 1, 1995·Journal of Neurosurgery·P D ChanR A Ashforth
Jul 19, 2003·Stroke; a Journal of Cerebral Circulation·Randall T HigashidaUNKNOWN Technology Assessment Committee of the Society of Interventional Radiology
Feb 7, 2007·Expert Review of Medical Devices·Michael AyadRobert A Mericle
Oct 13, 2007·Neuroradiology·Thomas LiebigHans Henkes
Nov 3, 2007·AJNR. American Journal of Neuroradiology·J GrallaC Brekenfeld
Mar 1, 2008·Stroke; a Journal of Cerebral Circulation·Caspar BrekenfeldJan Gralla
Mar 21, 2009·AJNR. American Journal of Neuroradiology·C BrekenfeldJ Gralla
Dec 19, 2009·AJNR. American Journal of Neuroradiology·P MordasiniJ Gralla
Jan 23, 2010·AJNR. American Journal of Neuroradiology·I KanF Viñuela
Jul 17, 2010·AJNR. American Journal of Neuroradiology·R Jahan
Oct 23, 2010·AJNR. American Journal of Neuroradiology·P MordasiniC Brekenfeld
Oct 13, 2011·Journal of Neurointerventional Surgery·Raul G NogueiraAdnan H Siddiqui
Dec 31, 2011·AJNR. American Journal of Neuroradiology·I YukiF Vinuela
Feb 4, 2012·AJNR. American Journal of Neuroradiology·C RothW Reith
Jul 28, 2012·AJNR. American Journal of Neuroradiology·P MordasiniJ Gralla
Aug 21, 2013·Clinical Neuroradiology·K J WengerM Wagner
Dec 18, 2014·The New England Journal of Medicine·Olvert A BerkhemerUNKNOWN MR CLEAN Investigators
Feb 12, 2015·The New England Journal of Medicine·Bruce C V CampbellUNKNOWN EXTEND-IA Investigators
Feb 12, 2015·The New England Journal of Medicine·Mayank GoyalUNKNOWN ESCAPE Trial Investigators
Apr 18, 2015·The New England Journal of Medicine·Jeffrey L SaverUNKNOWN SWIFT PRIME Investigators
Apr 18, 2015·The New England Journal of Medicine·Tudor G JovinUNKNOWN REVASCAT Trial Investigators
Sep 17, 2015·Stroke; a Journal of Cerebral Circulation·Diogo C HaussenRaul G Nogueira
Mar 27, 2016·Journal of Neurointerventional Surgery·Paolo MachiVincent Costalat
Aug 2, 2017·JAMA : the Journal of the American Medical Association·Bertrand LapergueUNKNOWN ASTER Trial Investigators
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
Dec 29, 2020·World Neurosurgery·Jan BorggrefeMarc Schlamann
Mar 17, 2021·Journal of Neurointerventional Surgery·Yang LiuLuis Savastano
Apr 6, 2019·Journal of Neuroradiology. Journal De Neuroradiologie·M RiboA Tomasello