Development Of The Neuroguard IEP 3- In-1 Carotid Stent .
Development of The Neuroguard IEP ️ 3in-1 Carotid Stent and Post-DilationBalloon System with Integrated EmbolicProtectionRavish Sachar, M.D. F.A.C.C.Physician-in-ChiefHeart and Vascular Service LineUNC-REX HealthcareUniversity of North Carolina
DisclosureSpeaker name:.I have the following potential conflicts of interest to report:ConsultingEmployment in industryX Stockholder of a healthcare companyX Owner of a healthcare companyOther(s)I do not have any potential conflict of interest
How can we further improve the carotidstenting procedure? Minor stroke remains a the Achilles Heal of CASWorldwide, most CAS procedures are are protected by one distal filterMost commercially available distal filters may not be well opposed to the vesselwall and have 100 micron poresThis allows microembolizationThe number of steps in CAS is 9Number of steps increases risk of procedure
Strategies to Protect AgainstMicroembolization During CAS Mesh Covered Stents Proximal Occlusion
Comparison of Particle Counts in CAS withMesh-Covered Stents vs Non-Mesh Covered StentsPaladin Filter Roadsaver StentNumber of particles collected350030143000250020001500Paladin Filter Non-mesh coveredstentsN 101784N 131000500117149040-100101-200Particle size, micronsp 0.13 using the t-test1652201-400
Slow Flow after Mesh-Covered Stenting
Stent Thrombosis with MeshCovered Stents?Asymptomatic delayedstent occlusion after duallayer micromesh stenttreatment for high gradecarotid artery stenosisStruffert T., Engelhorn T.,Gölitz P., Lücking H., DörflerA., University of Nuremberg,Erlangen, GERMANY
Filter Histology in Patient Treated with Mo.MAand PaladinProcedureperformed inLeipzig, Germanywith MedtronicMo.MA proximalprotectionsystemParticle Count2,5992599Courtesy: Dr.Andrej Schmidt136Particle SizeParticle Count299740-99136199252997 3002599136257
Neuroguard IEP 3-in-1 System
Neuroguard IEP Carotid Stent
Neuroguard IEP Carotid Stent
Neuroguard IEP Carotid StentStent Design Closed CellAsymmetrical hourglass designFlared endsOptimized Radial Strength and Flexibility9 mm7 mmStent Lengths (30, 40 mm)Mid Stent OD (6, 7 mm)
Neuroguard IEP Carotid StentKink Resistance to 270o
Neuroguard IEP Carotid StentOptimized Flexibility/ConformabilityAbbott Xact StentNeuroguard IEP
Neuroguard IEP Carotid StentRadial Force0,60,5N/mm0,40,30,20,10Contego Abbott XactNeuroguard 7 mm7 mmContego Boston SciNeuroguard Wallstent 66 mmmm
Neuroguard IEP Carotid StentStent Free Cell AreaStent �AcculinkStent DesignClosed cellClosed cellClosed cellClosed cellOpen cellOpen cellOpen cellFree Cell Area (mm2)1.082.743.54.75.8920.7111.48
Neuroguard IEP Carotid Stent400 Million Cycle Fatigue TestingNo breakage wasobserved on any of thetest articles following400,000,000 cycles
Neuroguard IEP Carotid StentMRI CompatibilityT1 Weighted, spin echo pulse sequenceNon-clinical testing demonstrated that theNeuroguard Carotid Stent is MR Conditional.A patient with this device can be scannedsafely in an MR system
6-Month Porcine StudyThere was no procedural injury inthe stented vessels The Neuroguard stent was fullybiocompatible at 6 months The stented segments showed nostenotic response. The filter deployment region showedno neointima formation. The downstream tissues werenormalAbbott Xact StentStent Stent6-Month HistopathologyResultsNeuroguard IEP
Summary The biggest risk of stroke is due to inadequate embolic protection duringindex procedure Micro embolization is important and causes minor stroke The Neuroguard IEP has been developed to address this issue in a safe andefficient manner Will be studied in detail in the PERFORMACE I and II Trials (400 patientstotal)
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Stent Type Stent Design Free Cell Area (mm2) Wallstent Closed cell 1.08 Xact Closed cell 2.74 Neuroguard Closed cell 3.5 Nexstent Closed cell 4.7 Precise Open cell 5.89 Protégé Open cell 20.71 Acculink Open cell 11.48 Stent Free Cell Area Neuroguard IEP Carotid Stent
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IEP CONTENT (Required): Date of IEP Meeting: / / Initiation Date of IEP: / / Projected Date of Annual IEP Review: / / Parent(s)/Legal Guardian(s) provided copy of this IEP: / / PARTICIPANTS IN IEP MEETING AND ROLE(S) The names and roles of individuals participating in developing the IEP meeting must be documented.
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