The Latest In Carotid Stent Technology Promise And Limitations
The Latest in Carotid Stent Technology– Promise and LimitationsRalf Langhoff, MDVascular Center Sankt GertraudenBerlinSankt Gertrauden-HospitalCharité, CC11Academic Teaching Hospitals ― Charité Berlin
Higher Minor Stroke During CAS vs CEAImportance of Micro-Embolization7,006,00CAS (%)CEA (%)5,004,003,002,001,000,00ACT 1SAPPHIREMas, J.L., et al, Endarterectomy versus stenting in patients with symptomatic severe carotid stenosis. N Engl JMed. 2006 Oct 19;355:1660–1671Brott TG et al. Stenting versus endarterectomy for treatment of carotid-artery stenosis. N Engl J Med. 2010; 363: 11–23Massop D et al. SAPPHIRE Worldwide Registry first 2,001 patients. Catheter Cardiovasc Interv. 2009 Feb 1;73(2):129-36.doi: 10.1002/ccd.21844.Kenneth Rosenfield, M.D., M.H.C.D.S., et al, N Engl J Med 2016; 374:1011-1020, March 2016 DOI:10.1056/NEJMoa1515706CRESTEVA 3S
When Do Stroke Occur?80706050% 4030The Vast Majority of the Risk of Stroke Occurs ntingPost-Procedure
Integrated Embolic Protection (IEP)TMAngioplastyBalloonIntegrated Filterwith optimizedpore size anddesignCatheter The first device that combines an embolic protection filter and balloon/stent Platform designed for ease of use, enhanced safety and efficiency Only filter that allows physicians to adjust filter size and optimize wallapposition Patented filter design maximizes embolic capture and side branch protection Reduces hospital inventory costs
Proven Superior Capture Efficiency% of 75-90 µm Emboli CapturedThe Contego System has the Highest Capture Efficiency of 4 Embolic Filters petitor 1Competitor 2Contego filter captured 100% of 75-90 µmembolic particles0
How can wefurther improvethe carotidstentingprocedure? Stent deployment in most currentprocedures is still protected by a distalfilter Distal filters may not be well opposed tothe vessel wall and has 100 micron pores The number of steps in CAS is 9 Number of steps increases risk ofprocedure
Neuroguard IEP 3-in-1 System
Neuroguard IEP Carotid Stent
Neuroguard IEP Carotid Stent Closed cell design Asymmetrical hourglassdesign Minimalforeshorterning High radial force Excellent flexibility andconformability
Neuroguard IEP Carotid StentStent Design Asymmetrical tapered design Flared ends9 mm7 mmStent Lengths (30, 40 mm)Mid Stent OD (6, 7 mm)
Neuroguard IEP Carotid Stent
Neuroguard IEP Carotid StentBest in Class Flexibility/ConformabilityAbbott Xact StentNeuroguard IEP
Neuroguard IEP Carotid StentStent Free Cell AreaUnsupported Cell Area: 3.5 mm2Largest Inscribed Circle: 0.8 mm
Neuroguard IEP Carotid Stent
PERFORMANCE I Protection against Emboli during carotid stenting using a 3-in-1 delivery system compRisingoF a pOst-dilation balloon, integRated eMbolic filter And Novel Carotid stEnt I A multinational feasibility trial of the Neuroguard IEP Carotid Stent System in Europe beginning in Q1 2018Approximately 100 subjects, with preliminary analysis performed at 56The primary endpoint is the 30-day rate of MAE, defined as the cumulative incidence of any periprocedural ( 30 days post-procedure) death, stroke or MI.InvestigatorsCountryProf. Alberto Cremonesi , Coordinating PICotignola, ItalyDr. Ralf LanghoffBerlin, GermanyProf. Ivo PetrovSofia, BulgariaProf. Dierk ScheinertLeipzig, GermanyProf. Sasko KedevSkopje, MacedoniaDr. Zoran MilosevicLjubljana, Slovenia
PERFORMANCE II A US multicenter clinical study to evaluate the safety andefficacy of the Neuroguard IEP Carotid Stent System Approximately 300 subjects will be enrolled, and will befollowed through 36 months post-procedure The primary endpoint is the 30-day rate of major adverseevent (MAE), defined as death, stroke or myocardial infarction(MI) within 30 days of the index carotid stenting procedure,and ipsilateral stroke at 12 months of procedure. Start Date Q3 2018
What are the other strategies for CAS?What are theotherstrategies forCAS? Proximal Occlusion Mesh Covered Stents TCAR Single distal filter
Proximal OcclusionProximalOcclusion Several studies and metaanalyses show low proceduraland 30-day MAE rates Independent of type of stentused Strongly suggests that themajority of the risk of strokeduring CAS is procedural and notafter discharge
Proximal OcclusionProximalOcclusion Large Arteriotomy 7/8F Flow cessation may result insymptoms External carotid artery occlusionmay not be possible in some cases The last step to remove theballoon out of the external carotidis unprotected
Procedureperformed inLeipzig, Germanywith MedtronicMo.MA proximalprotection systemParticle CountFilter Histology in Patient Treatedwith Mo.MA and PaladinParticle SizeParticleCountCourtesy: Dr. Andrej Schmidt40-99199299 30025991362577
Mesh CoveredCarotid Stents– Single CenterExperience 38 patients enrolled in 2 meshcovered stent studies 3 acute stent occlusions resulting instroke within 12 days One patient noncompliant with DAPT Two patient compliant with DAPT 3 cases of ISR within 6 months
Restenosis in Mesh Covered Stents
Stent Thrombosis with MeshCovered Stents?Asymptomatic delayed stent occlusionafter dual layer micromesh stenttreatment for high grade carotid arterystenosisStruffert T., Engelhorn T., Gölitz P.,Lücking H., Dörfler A., University ofNuremberg, Erlangen, GERMANY
Slow Flow after Mesh-CoveredStenting
TCARTCAR Avoids Aortic Arch Requires surgical cutdown and anesthesia ?
SummaryConclusion The biggest risk of stroke is due to inadequate embolicprotection during index procedure, especially duringpost-dilation Micro embolization is important and causes minor stroke Mesh covered stents, while an improvement, do not stopmicro-embolization Stent thrombosis may be an issue Transfemoral or trans-radial stenting with experiencedoperators using a closed cell stent design and improvedembolic protection during index procedure may be thesafest option
ThankYou ForYour Attention!Ralf Langhoff, MDVascular Center Sankt GertraudenBerlinSankt Gertrauden-HospitalCharité, CC11Academic Teaching Hospitals ― Charité Berlin
The Latest in Carotid Stent Technology– Promise and LimitationsRalf Langhoff, MDVascular Center Sankt GertraudenBerlinSankt Gertrauden-HospitalCharité, CC11Academic Teaching Hospitals ― Charité Berlin
PERFORMANCE I Protection against Emboli during carotid stenting using a 3-in-1 delivery system compRising oF a pOst-dilation balloon, integRated eMbolic filter And Novel Carotid stEnt I A multinational feasibility trial of the Neuroguard IEP Carotid Stent System in Europe beginning in Q1 2018 Approximately 100 subjects, with preliminary analysis performed at 56
group, with Xact Carotid stent (Abbott Vascular, Santa Clara, California), Nexstent Carotid stent, Carotid Wallstent (Boston Scientific, Natick, Massachusetts) being classified as closed-cell stent and Precise carotid stent, Protégé carotid stent (Cordis, Warren, New Jersey), Acculink carotid stent (Acculink system,
Abbott Vascular XACT Carotid Stent System P040038 Sep 2005 Boston Scientific Corp. Carotid Wallstent Monorail Endoprosthesis P050019 Oct 2008 Boston Scientific Corp. Endotex Nexstent Carotid Stent and Delivery System and Endotex Carotid Stent and Monorail Delivery System P050025 Oct 2006 Medtronic Vascular
Xact Carotid Stent Open cell stent design . Carotid WALLSTENT Endoprosthesis Precise PRO Rx Nitinol Stent System RX Acculink Carotid Stent. Influence of Stent Cell Design on Adverse Events Cell design Total Population Without protection With protection Closed Cell 5.9% (26/437) 5.8% (21/362) 6.7% (5/75) Open Cell 11% (14/127) 12.3%
evaluated based on three of the evaluated carotid stent models. Two out of five stent models (Acculink RX 10 mm and Precise 10mm) had the same distal outer stent sheath diameter but a different stent sheath length. Two stent models (Precise 7mm and Precise 10mm) had the same distal outer stent sheath length but a dif-ferent stent sheath diameter.
May 02, 2018 · D. Program Evaluation ͟The organization has provided a description of the framework for how each program will be evaluated. The framework should include all the elements below: ͟The evaluation methods are cost-effective for the organization ͟Quantitative and qualitative data is being collected (at Basics tier, data collection must have begun)
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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
with the requirements of ISO 14001:2015? 4.4 14 Has your organization has considered the knowledge and information obtained by 4.1 and 4.2 when implementing and operating it EMS? Insert your company’s name or logo. ISO 14001:2015 Audit Checklist System & Process Compliance Auditing www.iso-9001-checklist.co.uk Page 6 of 41 Audit Findings Summary Manually transfer the audit findings from the .
