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Novel self-expanding nitinol carotid
stent with hybrid cell design - first in
man application
Krzysztof Milewski, MD, PhDAssistant Professor, General Director
Center for Cardiovascular Research and Development
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Background
• Although CEA remains the gold standard for
coronary artery stenosis treatment, CAS has
been widely utilized as an alternative approach,
especially in situations when CEA has been
contraindicated due to severe comorbidities or
unfavorable anatomy
• In order to further improve the outcomes of CAS
and to expand clinical indications for this
technique further research and technology
improvements are required.
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• Recent studies have shown that stent design could
influence the outcomes, suggesting that adverse events
rates vary according to free cell area and cell design
30-day outcome Open cell % (n = 110) Closed cell (n = 365)
TIA 7.2 (8) 0.8 (3)
Stroke 0.9 (1) 1.1 (4)
Death 0.0 (0) 0.3 (1)
TIA/stroke/death 8.1 (9) 2.2 (8)
Subgroup analysis of the 480 patients with echolucent plaques
P = .0343
Hart JP; J Vasc Surg. 2006
Stent design
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Closed cell design Open cell design
Surface area:
From 1.08 mm2 to 4.7 mm2
Surface area:
From 5.89 mm2 to 11.48 mm2
Standard carotid stent design
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Closed cell design Open cell design
• Vessel scafolding
• Support for unstable /
fractured plaque
• Support for thrombogenic
material
• Elasticity & deliverability
• Local anatomy conformability
Hybrid stent design
a compromise?
Standard carotid stent design
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Hybrid stent design Cristallo Ideale
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Closed cell design Open cell design
• Vessel scafolding
• Support for unstable /
fractured plaque
• Support for thrombogenic
material
• Elasticity & deliverability
• Local anatomy conformability
Hybrid stent design
a compromise? any different way?
Hybrid cells design
Standard carotid stent design
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• Self-expandable nitinol stent with
tantal markers on the ends.
• The stent is cut off from nitinol tube
by a laser.
• It has hybrid cells technology which
combines repeating unicellular
modules designed of ”s-like” shaped
cells through the whole length of the
stent
MER® Hybrid Cells Technology- a Novel Approach for the Treatment of Carotid Artery Stenosis
HybridClosed Open
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Evaluation of safety, feasibility of
implantation and vascular response of
a novel self-expandable nitinol MER®
stent (Balton) with hybrid cells
technology implanted into porcine
carotid arteries
Preclinical testing
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QVA Pre- implantaion (IQR) Follow up at 28 day (IRQ) P value
MLD 4.4(0.57) 4.51(0.3) .089
RVD 4.57(0.49) 4.96(0.3) < .0001
DS% 6.58(16.57) 10.18(8.07) .014
LLL -0.115 (0.26)
Immediately after implantation 28 days follow up
Angiographic results
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0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
1
Injury Score InflammationScore
Fibrin Score Mean Intimalthickness (mm)
Semiquantitative histology
MER® Hybrid Cells Technology- a Novel Approach for the Treatment of Carotid Artery Stenosis
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Histomorphometry
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First-In-Man Clinical Use
MER® Hybrid Cells Technology- a Novel Approach for the Treatment of Carotid Artery Stenosis
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First-In-Man Clinical Use
MER® Hybrid Cells Technology- a Novel Approach for the Treatment of Carotid Artery Stenosis
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First Clinical Trial to Evaluate Safety and
Feasibility of MER® stent
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Catalogue
No.
Filtering basket
diameter
[mm]
Recommended
for vessel
diameter
Guide wire
length
[cm]
SDN4RX 4 .014” 170
SDN5RX 5 .014” 170
SDN6RX 6 .014” 170
SDN7RX 7 .014” 170
SDN8RX 8 .014” 170
Rapid Exchange
Catalogue
No.
Filtering basket
diameter
[mm]
Recommended
for vessel
diameter
Guide wire
length
[cm]
SDN4OTW 4 .014” 300
SDN5OTW 5 .014” 300
SDN6OTW 6 .014” 300
SDN7OTW 7 .014” 300
SDN8OTW 8 .014” 300
Over the wire
Two delivery & capture system types
Filtering basket made of biocompatible
materials;
filter holes diameter: 100÷120 µm
PTFE .014” guide wire integrated with
filtering basket
Atraumatic, flxible end-tip of the guide wire
facilitates safe reaching of the area beyond
lesion
outstanding X-ray visibility
®
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• The MER stent is characterized by optimal
biocompatibility expressed by low
inflammatory and wall injury scores, as well
as by complete endothelization
• Although the first clinical experience showed
good procedural parameters and early
clinical results, further clinical trials are
warranted to fully confirm advantages of this
promising technology
Conclusions