Carotid Artery Stenting Latest TechnologyRalf Langhoff, MDVascular Center Sankt GertraudenBerlinCharité, CC11Academic Teaching Hospitals ― Charité
What Would Be a Gamechanger in CAS Procedures for You? if you could add safety ? if you could add safety by don’t change your strategy? if you don’t have to consider on device choice? if you could reduce procedural steps to a minimum? if you reduce procedural time?
While CAS Results Are Steadily Improving30 Day Death/Stroke/MI1230 DayDeath/Stroke/MI1086420References available for individual study resultsProspective multi-center studies with 100 patients
Minor Stroke During CAS: Remains An Unsolved Issue7.030-Day Risk of Minor StrokeCEA vs CAS6.05.04.0CAS (%)CEA (%)3.02.01.00.0ACT 1SAPPHIRECRESTEVA 3S
The Solution: PaladinAngioplastyBalloonIntegrated Filter: 40 Micron pores Baseline closed SheathlessCatheter The first device that combines an embolic protection filter and balloon/stent 40 micron pore size allows micro-embolic capture Filter size can be adjusted to suit each patient’s unique anatomy The Post-Dilation Solution for EVERY Carotid Stent Procedure
Clinical Data: Comparison of PaladinWith Other Carotid StudiesPaladin demonstrates lowest stroke ratescompared to other CAS studies*8.3%Paladin Study: 7.2%6.7%6.1%5.4%106 patientsNo procedural stroke1 unrelated CABERNET2004CREATE2005EMPIRE2008EPIC200830-Day Death, Stroke or MIESC Guidelines on the diagnosis and treatment of peripheral artery disease, 2011 Paladin results, 2016 study*Prospective multi-center studies with 100 patientsPROTECT2009ARMOUR2009CEA CREST2011CAS CREST2011ROADSTER2015PALADIN2016
MRI DATAIncidence and Size of of New Lesions on MRI Were Significantly Lower Than OtherTechnologiesComparative DW-MRI ResultsPaladin(n 33)PROFI1Proximal group(n 31)PROFI1Filter group(n 31)ICSS2Filter group(n 37)CARENET3CGuard(n 26)Incidence of New Lesions21.2%45%87%73%48%Mean number of lesions per pt.0.241.0 /- 1.43.6 /- 3.2Mean Lesion Volume (cm3)0.0050.160.59NA0.05Data courtesy Joachim Schofer MD et al.1Bijuklic K, Wandler A, Hazizi F, Schofer J. The PROFI Study. JACC 2012 Apr 10;59(15):1383-9.Bonati LH, et al, ISCC-MRI Study group. New ischaemic brain lesions on MRI after stenting or CEA for symptomatic carotid stenosis: a substudy of ICSS. Lancet Neurol. 2010 Apr;9(4):353-62.3 Schofer J, Musialek P, Bijuklic K, Kolvenbach R, Trystula M, Siudak Z, Sievert H. The CGuard CARENET Trial. JACC Cardiovas Interv. 2015 Aug 17;8(9):1299-34.2
Filter Histological Analysis:Particle SizeParticle FrequencyMajority Of Particles Captured Were 100 MicronsSize (μm)
Filter Histological Analysis:Major Points 90% of particles captured were less than 100 microns in size These are NOT captured by current filters, but ARE captured by PALADIN Consistent with MRI findings
PaladinClinical Experience 1600 Cases With No Reported Strokes to Date
NeuroVascular DevicesPaladin Neuroguard Making every Carotid Artery Stentingprocedure saferEnd-to-end solution forCarotid Artery Stenting2 in 1: PTA balloon IEP3 in 1: Stent PTA balloon IEP Targeting All CAS Cases 1100 Cases Done with noreported strokesApproval Timing:CE Mark: US 510(k): Poised to capture a significantportion of the CAS market worldwideApproval Timing:CE Mark: 1Q 2019US PMA: 2021
How can wefurtherimprove thecarotidstentingprocedure? Stent deployment in most currentprocedures is still protected by a distal filterwhich may not be well opposed to the vesselwall and has 100 micron pores The number of steps in CAS is 10 Number of steps increases risk of procedure
Steps of Carotid ar Access (femoral - brachial)Angiographic evaluationGuiding Sheath PlacementCrossing the Stenosis- without protection- with distal protection- with proximal protectionLesion PredilatationRemoving the BalloonAdvancing the StentStent DeploymentRemoving the SDSAdvancing Postdilation BalloonRemoving Postdilation BalloonAdvancing the Filter Retrieval CatheterRemoval of Protection DeviceFinal Angiographic ControlSheath removal/ Access Care10 times crossing of the lesionThis can be reduced to 3 steps withNeuroguard IEP
Neuroguard
Neuroguard IEP Carotid Stent
Neuroguard StentStent Lengths (30, 40 mm)Mid Stent OD (6, 7 mm)
Neuroguard Stent – Apposition / FlexibilityAbbott Xact StentNeuroguardNeuroguardFlexibility
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
PERFORMANCE IProtection against Emboli during carotid stenting using a 3-in-1 delivery system compRising oF a pOst-dilationballoon, integRated eMbolic filter And Novel Carotid stEnt IThe primary endpoint is the 30-day rate of MAE, defined as the cumulative incidence of any periprocedural ( 30days post-procedure) death,stroke or MI.CountryBulgariaItalyGermanyGermanyPrincipal InvestigatorIvo Petrov, MDAlberto Cremonesi,MD(Coordinating PI)Eugenio Stabile, MDDierk Scheinert, MDRalf Langhoff, MDGermanyJoachim Schofer, MDGermanyMacedoniaSloveniaHorst Sievert, MDSasko Kedev, MDZoran Milosevic, MDItalyHospitalAcibadem City Clinic, SofiaStatus23 patientsMaria Cecilia Hospital , Cotignola2 patientsUniversity of Naples Frederico II, NaplesUniversitätsklinikum Leipzig, LeipzigSankt Gertrauden Krankenhaus, BerlinMedizinische Versorgungszentrum,HamburgSankt Kathariene Krankenhaus, FrankfurtUniversity Clinic of Cardiology, SkopjeMC Medicor, IzolaTotal Patients enrolled5 patients2 patients6 patients*51 patients have completed 30 day follow up* 13 patients have completed 6 month follow up1 patient3 patients12 patients5 patients59 Patients
To Conclude: Minor stroke remains the ‘Achillles Heel’ during CAS The use of the Paladin System for post-dilation during CAS resultedin no procedural strokes an adds safety to our patients Hypothetically the use of Neuroguard IEP adds additional safetydue to less procedural steps and a very unique, closed cell, flexibleNitinol stent integrating the Paladin System The Neuroguard IEP has the potential to become a gamechanger
Thank You!Dr. Ralf LanghoffVascular Center Sankt GertraudenBerlinSankt Gertrauden-HospitalCharité, CC11Academ. Teaching Hospital of Charité-University Berlin26
Carotid Artery Stenting Latest TechnologyRalf Langhoff, MDVascular Center Sankt GertraudenBerlinCharité, CC11Academic Teaching Hospitals ― Charité
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 Neuroguard IEP Carotid Stent Stent Free Cell Area
CAD Coronary artery disease CaRESS Carotid Revascularization Using Endarterectomy or Stenting Systems CAS Carotid angioplasty and stenting CASANOVA Carotid Artery Stenosis with Asymptomatic Narrowing: Operation versus Aspirin CEA Carotid endarterectomy CI Confidence interval CREST Carotid Revascularization Endarterectomy Versus Stenting
as exercise), medication therapy (anti-platelet drugs, statins, antihypertensives), carotid endarterectomy (CEA) and carotid artery stenting (CAS). Carotid Artery Stenting (CAS): A stent is placed by catheter within an atherosclerotic carotid artery. An embolic protection device may be used to minimize debris dislodged during the procedure.
Lee W. General principles of carotid Doppler ultrasonography. Ultrasonography. 2014 Jan;33(1):11-17. Whal Lee 12 Ultrasonography 33(1), January 2014 e-ultrasonography.org Carotid Artery Anatomy and Tips for Differentiating the Internal Carotid Arteries from the External Carotid Arteries The right carotid artery arises from the right brachiocephalic artery. Ultrasonography can show the most .
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
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,
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
Atherosclerotic Disease is a Pan Vascular Process Coronary Artery Disease (CAD) Non-coronary Atherosclerosis -Peripheral Artery Disease (PAD) -Lower extremity -Upper extremity (subclavian stenosis) -Carotid artery disease -Renal artery disease -Mesenteric artery disease -Aortic aneurysm -Vasculogenic Erectile Dysfunction Vascular disease is
Mar 14, 2010 · Coronary artery bypass graft Left subclavian artery Circumflex artery Right coronary artery Figure 6. Coronary artery bypass grafting Treatment Options for Coronary Artery Disease CAD can be managed in several ways . Your doctor will recommend a treatment plan based on your symptoms, t