Mesh-Covered Stents For Carotid Intervention: Rationale .

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Mesh-Covered Stents for Carotid Intervention:Rationale, Device Designs, Imaging,and Data to DatePiotr Musialek, MD DPhilJagiellonian University Dept. of Cardiac & Vascular DiseasesJohn Paul II Hospital, Krakow, Poland

Disclosure Statement of Financial InterestWithin the past 12 months, I or my spouse/partner have had a financialinterest/arrangement or affiliation with the organization(s) listed below.Affiliation/Financial RelationshipCompany Grant/Research SupportConsulting Fees/HonorariaABBOTTABBOTT, Balton, InspireMD, Medtronic

Mesh-Covered Stents for Carotid InterventionRationaleP. Musialek @ TCT 2015

P. Musialek @ TCT 2015

CAS (and CEA) are –and will remain–emboli-generating proceduresP. Musialek @ TCT 2015

ΔP. Musialek @ TCT 2015

n 3179 consecutive CAS patients CAS neuro events (stroke, TIA)are POST-procedural 2/3P. Musialek @ TCT 2015

FREE CELL AREA drives CAS neurologic adverse events( and majority occur post-procedure )P. Musialek @ TCT 2015

Conventional Carotid StentJ. Schofer, P. Musialek et al. TCT 2014P. Musialek @ TCT 2015

Conventional Carotid StentImage Courtesy Dr Juan Rigla, MD PhDPerceptual Imaging Lab, Univerity of BarcelonaP. Musialek @ TCT 2015

current best-in-classHybrid stentcurrent best-in-classClosed-cell stentP. Musialek @ TCT 2015

ANY dataon incidence ofPLAQUE PROLAPSEinconventional carotid stents ?P. Musialek @ TCT 2015

P. Musialek @ TCT 2015

Post-procedural PLAQUE PROLAPSE through conventional stent strutsDe Donato et al. Eur J Vasc Endovasc Surg 2013;45:579-587.P. Musialek @ TCT 2015

Conventional Carotid StentImage Courtesy Dr Juan Rigla, MD PhDPerceptual Imaging Lab, Univerity of BarcelonaP. Musialek @ TCT 2015

Conventional Carotid StentJ. Schofer, P. Musialek et al. TCT 2014P. Musialek @ TCT 2015

CREST30 dP. Musialek @ TCT 2015

CRESTCRESTP. Musialek @ TCT 2015

CRESTCRESTP. Musialek @ TCT 2015

CRESTCRESTP. Musialek @ TCT 2015

CRESTCREST 2015we need to do betterP. Musialek @ TCT 2015

Conventional Carotid StentJ. Schofer, P. Musialek et al. TCT 2014P. Musialek @ TCT 2015

Anti - Embolic Carotid StentJ. Schofer, P. Musialek et al. TCT 2014P. Musialek @ TCT 2015

Mesh-Covered Stents for Carotid InterventionDevice DesignsP. Musialek @ TCT 2015

Mesh-Covered Stents for Carotid InterventionDevice Designsn 3P. Musialek @ TCT 2015

”Mesh” StentsTable by Terumo, used with permission

RoadSaverP. Musialek @ TCT 2015

RoadSaver Casper*Not available in the United States.P. Musialek @ TCT 2015

RoadSaver (Terumo) Casper (MicroVena)nitinol mesh INSIDE the nitinol frameImages by Terumo / used with permissionP. Musialek @ TCT 2015

RoadSaver: Push-Pull Stent Delivery Systemre-sheathable up to 50% stent length releaseCE Mark – January 2014Images courtesy P. Pieniazek / Krakow and TerumoP. Musialek @ TCT 2015

GORE Carotid StentOpen Cell NiTi FrameClosed Cell 500 µm PTFE lattice onoutside of NiTi FramePermanently Bound CBAS Heparin onall device surfacesCourtesy WL Gore & Associates / by permissionP. Musialek @ TCT 2015

Table by WL Gore & Associates / used with permissionNB. The Gore carotid stent is not avialable outside the SCAFFOLD StudyP. Musialek @ TCT 2015

The Gore Stent Delivery SystemStent/Sheath(5Fr or 6Fr)HubHandleAttributes SingleHypotubeRO Markers(2.4 Fr)NB. The Gore carotid stent is not avialable outside the SCAFFOLD Studyhanded delivery 5Fr Introducer SheathCompatible (White Tip) 6Fr Introducer SheathCompatible (Gray Tip) Hypotube Design– Allows for completeclosure ofhemostatic valve 135 cm Working Length 30 cm RxP. Musialek @ TCT 2015

*Not available in the United States; available in Europe and a number of other geographiesP. Musialek @ TCT 2015

CGuard Embolic PreventionStent SystemCE Mark – March 2014P. Musialek @ TCT 2015

CGuard Embolic PreventionStent SystemRx porttipImages by InspireMD, used with permissionP. Musialek @ TCT 2015

Pore SizeCGUARD *165µm 375µm500µm1050µmClosed cell stent1900µmOpen cell stentROADSAVER CASPERGOREP. Musialek @ TCT 2015* Average in lesion at expanded state

RoadSaveraka CasperNameclosed-cellNitinolStent frameGore Carotid StentCGuard Embolic Prevention Stentopen-cellNitinolopen-cellNitinolMesh position in re-lation to frameinsideoutsideMesh materialNitinolPTFEMesh structurebraidedinter-wovenPore size375 µm500 µmPTFE PolytetrafluoroethyleneoutsidePETsingle-fiber knittedPET poliethylenteraphtalat150 - 180 µmP. Musialek @ TCT 2015

Mesh-Covered Stents for Carotid InterventionDatahistology / animalP. Musialek @ TCT 2015

PA Schneider VERVE 2014, animal data WL Gore / by permissionP. Musialek @ TCT 2015

Histology and REMRoadSaverafter 6 monthsData by Terumo / used with permissionP. Musialek @ TCT 2015

CGuard EPS 90 days / pigInspireMD data / by permissionP. Musialek @ TCT 2015

CGuard EPS 30 & 90 days/pigBMS non mesh-covered CGuard nitynol frame; InspireMD data / used with permissionP. Musialek @ TCT 2015

Mesh-Covered Stents for Carotid InterventionImagingangioP. Musialek @ TCT 2015

Roadsaver / CasperAngio/CAS images courtesy P. Pieniazek / KrakowP. Musialek @ TCT 2015

Gore Carotid StentAngio/CAS images courtesy Dr. C. SchönholzP. Musialek @ TCT 2015

CGuard EPSAngio/CAS images P. MusialekP. Musialek @ TCT 2015

Mesh-Covered Stents for Carotid InterventionImagingIVUSP. Musialek @ TCT 2015

P. Musialek @ TCT 2015

Mesh-Covered Stents for Carotid InterventionImagingOCTP. Musialek @ TCT 2015

RoadSaverCourtesy of Dr. Max Amor, Essey les NancyData by Terumo / used with permissionP. Musialek @ TCT 2015

CGuard EPSThrombotic materialTRAPPEDbetween the stentMicroNETand the vessel wallImage Courtesy Dr Juan Rigla, MD PhDPerceptual Imaging Lab, Univerity of BarcelonaP. Musialek @ TCT 2015

CGuard EPSP. Musialek @ TCT 2015

Mesh-Covered Stents for Carotid InterventionImagingCTP. Musialek @ TCT 2015

CGuardImages M.Urbanczyk / Z.Moczulski / M.Irzyk / P.BanyśJP2 Hospital, Krakow, PolandP. Musialek @ TCT 2015

CGuardImages M.Urbanczyk / Z.Moczulski / M.Irzyk / P.BanyśJP2 Hospital, Krakow, PolandP. Musialek @ TCT 2015

Mesh-Covered Stents for Carotid Interventionpublished*Evidence* full paper or journal abstract by October 2015P. Musialek @ TCT 2015

P. Musialek @ TCT 2015

P. Musialek @ TCT 2015

CGuard embolic prevention stentP.P. MusialekMusialek @@ TCTTCT 20152015

P. Musialek @ TCT 2015

P. Musialek @ TCT 2015

DW-MRI:the unforgiving testimonyof what you’ve doneto the TARGET ORGAN.P. Musialek @ TCT 2015

P. Musialek @ TCT 2015

P. Musialek @ TCT 2015

P. Musialek @ TCT 2015

P. Musialek @ TCT 2015

P. Musialek @ TCT 2015

P. Musialek @ TCT 2015

P. Musialek @ TCT 2015

P. Musialek @ TCT 2015

P. Musialek @ TCT 2015

Anti - Embolic Carotid StentJ. Schofer, P. Musialek et al. TCT 2014P. Musialek @ TCT 2015

Anti - Embolic Carotid StentJ. Schofer, P. Musialek et al. TCT 2014P. Musialek @ TCT 2015

CAS (and CEA) are –and will remain–emboli-generating proceduresamenable toeliminationwithmeshP. Musialek @ TCT 2015

CAS (and CEA) are –and will remain–emboli-generating proceduresamenable toeliminationwithMicroNet MicroNetprotectionduringstent healing!P. Musialek @ TCT 2015

Prospective evaluation of All-comer peRcutaneous cArotiD revascularization In symptomatic and increased-risk asymptomatic carotidartery stenosis using CGuard Micronet-coveredembolic prevention stent system:The PARADIGM StudyEuroPCR 2015 (www.europcr.com) and TCT-73 (2015)P. Musialek @ TCT 2015

EuroPCR 2015 (www.europcr.com) and TCT-73 (2015)P. Musialek @ TCT 2015

EuroPCR 2015 (www.europcr.com) and TCT-73 (2015)P. Musialek @ TCT 2015

EuroPCR 2015 (www.europcr.com) and TCT-73 (2015)P. Musialek @ TCT 2015

EuroPCR 2015 (www.europcr.com) and TCT-73 (2015)P. Musialek @ TCT 2015

EuroPCR 2015 (www.europcr.com) and TCT-73 (2015)P. Musialek @ TCT 2015

*Dept. of Cardiac & Vascular Dieases, John Paul II Hospital,Krakow, Poland; 10.2014–03.2015P. Musialek @ TCT 2015

EuroPCR 2015 (www.europcr.com) and TCT-73 (2015)P. Musialek @ TCT 2015

EuroPCR 2015 (www.europcr.com) and TCT-73 (2015)P. Musialek @ TCT 2015

EuroPCR 2015 (www.europcr.com) and TCT-73 (2015)P. Musialek @ TCT 2015

EuroPCR 2015 (www.europcr.com) and TCT-73 (2015)P. Musialek @ TCT 2015

* Emboshield (n 7); FilterWire (n 14); Spider (n 25)** Gore FlowReversal (n 4) or flow reversal with MoMa (n 21)(NB. mean flow reversal time was 6min 48s, from 5min 18s to 11min 2s)# ø 4.5mm (n 5); ø 5.0mm (n 36); ø 5.5mm (n 29); ø 6.0mm (n 1);§ 30mm in 51 lesions; 40mm in 18 lesions (2 other lesions required two stents each)P. Musialek @ TCT 2015

EuroPCR 2015 (www.europcr.com) and TCT-73 (2015)P. Musialek @ TCT 2015

n 71 arteriesin 68 patientsEuroPCR 2015 (www.europcr.com) and TCT-73 (2015)P. Musialek @ TCT 2015

Procedure - RelevantInformationP. Musialek @ TCT 2015

Gore Carotid StentCGuard Embolic Prevention StentNameRoadSaveraka CasperRe-sheathable ?yes*nonoCrossing profile5F5F (smaller diam)6F (larger diam)6FForeshorteningyesStent placementaccuracy–N/D Ability to eliminateresidual stenosisN/DN/DyesExternally-analysedsystematicDW MRI study dataunknownunknownyesunknown**no#####*up to 50% released length # PARADIGM PCR2015 and TCT-73N/D not determined**probably not substantial ## CARENET JACC Intv 2015;8:1229P. Musialek@ TCT 2015

on-goingStudiesP. Musialek @ TCT 2015

Roadsaver50% patient cohort recruitment threshold crossed P. Musialek @ TCT 2015

P. Musialek @ TCT 2015

P. Musialek @ TCT 2015

GORE Carotid Stent Clinical Study forthe treatment of carotid Artery stenosisin patients at increased risk For adverseevents From carOtid enDarterectomyThe Gore SCAFFOLD Clinical StudyPIs: P.A. Schneider and W.A. Gray Number of Subjects312 subjects (max 40 at each site) Primary EndpointNCT # 01901874Composite of Major Adverse Events (MAE) defined as death,any stroke, or myocardial infarction through 30 days post indexprocedure plus ipsilateral stroke between 31 days and 1 year*All primary endpoint events will be determined by the study Clinical Events Committee 50% patient cohort recruitment threshold crossed Data expected 2017Study data courtesy WL Gore & Associates P. Musialek @ TCT 2015

Announced:Planned enrollment: n 200 patientsPrimary endpoint:clinical – MAEdeath/stroke/MI 30 daysP. Musialek @ TCT 2015

PARADIGM – Extend(aka PARADIGM-101) subacute strokePI: P. Musialek / KrakowP. Musialek @ TCT 2015

Mesh-Covered Stents for Carotid InterventionremainingUnknownsP. Musialek @ TCT 2015

Mesh-Covered Stents for Carotid InterventionRemaining Unknowns (1). Is there a product/design-specific ”gradient”in the embolic prevention efficacy?P. Musialek @ TCT 2015

Mesh-Covered Stents for Carotid InterventionRemaining Unknowns (1). Is there a product/design-specific ”gradient”in the embolic prevention efficacy?P. Musialek @ TCT 2015

Mesh-Covered Stents for Carotid InterventionRemaining Unknowns (1). Is there a product/design-specific ”gradient”in the embolic prevention efficacy?P. Musialek @ TCT 2015

Mesh-Covered Stents for Carotid InterventionRemaining Unknowns (2). Large-scale (muli-center, multi-hundred patient),controlled clinical endpoint data?. Long-term treatment durability / ’no restenosis’ proofNB. sofar – no worrying signal. Role in open (CEA) vs. endo (CAS) balance. Role in primary stroke preventionP. Musialek @ TCT 2015

Mesh-Covered Stents for Carotid InterventionConclusionsP. Musialek @ TCT 2015

Mesh-Covered Stents for Carotid InterventionClinical evidence in October 2015 .1 peer-reviewed, published clinical study- multicenter, single-arm- DWI controlled (24-48h, 30d, external analysis)CARENET, JACC Intv 2015;8:1229-1234P. Musialek @ TCT 2015

Mesh-Covered Stents for Carotid InterventionClinical evidence in October 2015 .1 peer-reviewed, published clinical study- multicenter, single-arm- DWI controlled (24-48h, 30d, external analysis)CARENET, JACC Intv 2015;8:1229-1234several moderately-sized investigator-initiatedsingle arm studies with clinical endpoints- 1 with full 30-day data available in all-comers(others underway or planned)P. Musialek @ TCT 2015

Mesh-Covered Stents for Carotid InterventionClinical evidence in October 2015 .1 peer-reviewed, published clinical study- multicenter, single-arm- DWI controlled (24-48h, 30d, external analysis)CARENET, JACC Intv 2015;8:1229-1234several moderately-sized investigator-initiatedsingle arm studies with clinical endpoints- 1 with full 30-day data available in all-comers(others underway or planned) 300pts single-arm clinical-endpoint studydue to report in 2017P. Musialek @ TCT 2015

Mesh-Covered Stents for Carotid InterventionClinical evidence in October 2015 .1 peer-reviewed, published clinical study- multicenter, single-arm- DWI controlled (24-48h, 30d, external analysis)CARENET, JACC Intv 2015;8:1229-1234several moderately-sized investigator-initiatedsingle arm studies with clinical endpoints- 1 with full 30-day data available in all-comers(others underway or planned) 300pts single-arm clinical-endpoint studydue to report in 2017mesh-covered carotid stents have individual, specificcharacteristics but no comparative studies (and such may never be conducted)P. Musialek @ TCT 2015

Mesh-Covered Stents for Carotid InterventionClinical evidence in October 2015 .1 peer-reviewed, published clinical study- multicenter, single-arm- DWI controlled (24-48h, 30d, external analysis)CARENET, JACC Intv 2015;8:1229-1234several moderately-sized investigator-initiatedsingle arm studies with clinical endpoints- 1 with full 30-day data available in all-comers(others underway or planned) 300pts single-arm clinical-endpoint studydue to report in 2017mesh-covered carotid stents have individual, specificcharacteristics but no comparative studies (and such may never be conducted)P. Musialek @ TCT 2015

P. Musialek @ TCT 2015

P. Musialek @ TCT 2015

P. Musialek @ TCT 2015

P. Musialek @ TCT 2015

Embolic-Prevention Stent Image Courtesy Dr Juan Rigla, MD PhDPerceptual Imaging Lab, Univerity of BarcelonaP. Musialek @ TCT 2015P. Musialek @ TCT 2015

CAS 2010 VISIONCarotid Revascularization 2015 R E A L I T YEmbolic-Prevention Stent Image Courtesy Dr Juan Rigla, MD PhDPerceptual Imaging Lab, Univerity of BarcelonaP. Musialek @ TCT 2015P. Musialek @ TCT 2015

Rationale, Device Designs, Imaging, and Data to Date Piotr Musialek, MD DPhil Jagiellonian University Dept. of Cardiac & Vascular Diseases John Paul II Hospital, Krakow, Poland . Disclosure Statement of Financial Interest . Anti - Embolic Carotid Stent. CAS (and CEA) .

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