the neuroguard iep 3-in-1 carotid stent and post-dilation ... · 10 20 30 40 50 60 70 80 90 100 100...

The Neuroguard IEP®️ 3-in-1 Carotid Stent and Post-Dilation Balloon System with

Integrated Embolic Protection

Ravish Sachar, M.D. F.A.C.C.Physician-in-Chief

Heart and Vascular Service LineUNC-REX Healthcare

University of North Carolina

Disclosure

Speaker name:

.................................................................................

I have the following potential conflicts of interest to report:

Consulting

Employment in industry

Stockholder of a healthcare company

Owner of a healthcare company

Other(s)

I do not have any potential conflict of interest

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X

Higher Minor Stroke During CAS vs CEAImportance of Micro-Embolization

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7,00

ACT 1 SAPPHIRE CREST EVA 3S

CAS (%)

CEA (%)

• Mas, J.L., et al, Endarterectomy versus stenting in patients with symptomatic severe carotid stenosis. N Engl J Med. 2006 Oct 19;355:1660–1671• Brott TG et al. Stenting versus endarterectomy for treatment of carotid-artery stenosis. N Engl J Med. 2010; 363: 11–23• Massop 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/NEJMoa1515706

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 wall apposition

Patented filter design maximizes embolic capture and side branch protection

Reduces hospital inventory costs

Integrated Filter with optimized pore size and design

Angioplasty Balloon

Catheter

Integrated Embolic Protection (IEP)TM

Journal of the Neurological Sciences

Volume 328, Issue 1-2, 15 May

2013, Pages 58-63

Diffusion-weighted lesions

after carotid artery stenting

are associated with cognitive

impairment

Maggio, P.a, Altamura, C.a, Landi,

D.a, Migliore, S.a, Lupoi, D.b, Moffa,

F.c, Quintiliani, L.a, Vollaro, S.a,

Palazzo, P.a, Altavilla, R.a,

Pasqualetti, P.de, Errante,

CONCLUSIONS:

Our study showed that peri-procedural brain microembolic load

impacts negatively on cognitive functions, independently from

the influence of patients-related variables. © 2013 Elsevier B.V.

Cognitive Impairment Due to EmbolizationImportance of Micro-Embolization

J Vasc Surg. 2016 Dec 23. pii:

S0741-5214(16)31513-0. doi:

10.1016/j.jvs.2016.09.057.

Volume of subclinical embolic

infarct correlates to long-term

cognitive changes after

carotid revascularization.

Zhou W, Baughman BD, Soman S,

Wintermark M, Lazzeroni LC,

Hitchner E, Bhat J, Rosen A

.

CONCLUSIONS:

Cognitive assessment of procedure-related subclinical

microemboli is challenging. Volumes of embolic infarct correlate

with long-term cognitive changes, suggesting that

microembolization should be considered a surrogate measure

for carotid disease management.

Published by Elsevier Inc.

The Paladin System has the Highest Capture Efficiency of 4 Embolic Filters Tested

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100

43,75 6,25 0

% o

f 7

5-9

0 µ

mEm

bo

li C

aptu

red

Paladin Competitor 1 Competitor 2 Competitor 3

Data on file at Contego Medical

Paladin filter captured 100% of 75-90 µmembolic particles

Proven Superior Capture Efficiency

0 50 100 150 200 250 300 350

31-40

61-70

91-100

130

160

190

Particle Frequency

Size

, μm

Filter Histological Analysis: Particle Size

24 filters collected for analysis of emboli count and size

The majority of particles captured were

less than 100 microns

Filter Comparison

• From 23 paired samples, the Paladin filter collected on average

• 95% more particles by COUNT and

• 120% more particles between 40-10 microns

than the primary filter

24243

40531042

53332

3013724

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40000

50000

60000

40-100 101-200 201-400

Co

un

t

Particle Average Length Range (microns)

Number of Embolic Particles Collected in Paladin vs. Primary

Filter

Distal

Proximal

p<0.0001 using the t-test

Slow Flow after Mesh-Covered Stenting

The Paladin filter and Roadsaver captured 68% more particles by

COUNT and 69% more particles

between 40-10 microns

than the primary filter the Roadsaver stent

Comparison of Particle Counts in CAS with Mesh-Covered Stents vs Non-Mesh Covered Stents

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117 16

3014

149 520

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40-100 101-200 201-400

Nu

mb

er o

f p

arti

cles

co

llect

ed

Particle size, microns

Paladin Filter + Roadsaver Stent

N=13

N=10

p=0.13 using the t-test

Stent Thrombosis with Mesh-Covered Stents?

Asymptomatic delayed

stent occlusion after dual

layer micromesh stent

treatment for high grade

carotid artery stenosis

Struffert T., Engelhorn T.,

Gölitz P., Lücking H., Dörfler

A., University of Nuremberg,

Erlangen, GERMANY

Filter Histology in Patient Treated with Mo.MAand Paladin

>30029919940-99

Particle Count 7251362599

725136

2599

Par

ticl

e C

ou

nt

2,599

136299 7

Procedure performed in Leipzig, Germany with Medtronic Mo.MA proximal protection system

Courtesy: Dr. Andrej Schmidt

Particle Size

How can we further improve the carotid stenting procedure?

• Stent deployment in most current procedures is still protected by a distal filter

• Distal filters may not be well opposed to the vessel wall

• Distal filters have > 100 micron pores

• The number of steps in CAS is >9

• Number of steps increases risk of procedure

Neuroguard IEP 3-in-1 System

Neuroguard IEP Carotid Stent

Stent Lengths (30, 40 mm)Mid Stent OD (6, 7 mm)

Neuroguard IEP Carotid StentStent Design

• Asymmetrical tapered design• Flared ends

8 mm7 mm


Closed Cell Design

No kinking to >270o

Characteristic ResultStent deployment

accuracy<1 mm

Maximum stent foreshortening

14%

Kink Resistance 278 degrees

Conformability 278 degrees

0

0,1

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ContegoNeuroguard

7 mm

Abbott Xact7 mm

ContegoNeuroguard

6 mm

Boston SciWallstent 6

mm

N/m

m

Radial Force


Abbott Xact® Stent Neuroguard IEP

Optimized Flexibility/Conformability


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 European feasibility trial of the Neuroguard IEP Carotid Stent System beginning in Q1 2018

– Approximately 100 subjects, with preliminary analysis performed at 56

– The 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.

Investigators Country

Prof. Alberto Cremonesi , Coordinating PI Cotignola, Italy

Prof. Sasko Kedev Skopje, Macedonia

Prof. Ivo Petrov Sofia, Bulgaria

Prof. Dierk Scheinert Leipzig, Germany

Dr. Ralf Langhoff Berlin, Germany

Dr. Zoran Milosevic Ljubljana, Slovenia

PERFORMANCE II

• A US multicenter clinical study to evaluate the safety and efficacy of the Neuroguard IEP Carotid Stent System

• Approximately 300 subjects will be enrolled, and will be followed through 36 months post-procedure

• The primary endpoint is the 30-day rate of major adverse event (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

• PI: Dr. William Gray

Summary

• The biggest risk of stroke is due to inadequate embolic protection during

index procedure, especially during post-dilation

• Micro embolization < 100 micron particles is important and causes minor

stroke

• Trans-femoral or trans-radial stenting with experienced operators using

the Neuroguard IEP system may be a good option and will be

investigated further via the PERFORMACE Series of Trials

Thank you!

The Neuroguard IEP®️ 3-in-1 Carotid Stent and Post-Dilation Balloon System with

Integrated Embolic Protection

Ravish Sachar, M.D. F.A.C.C.Physician-in-Chief

Heart and Vascular Service LineUNC-REX Healthcare

University of North Carolina

the neuroguard iep 3-in-1 carotid stent and post-dilation ... · 10 20 30 40 50 60 70 80 90 100 100...

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