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

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.

• 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

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

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

Hybrid stent design Cristallo Ideale

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

• 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

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

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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0.9

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Injury Score InflammationScore

Fibrin Score Mean Intimalthickness (mm)

Semiquantitative histology

MER® Hybrid Cells Technology- a Novel Approach for the Treatment of Carotid Artery Stenosis

Histomorphometry

First-In-Man Clinical Use

MER® Hybrid Cells Technology- a Novel Approach for the Treatment of Carotid Artery Stenosis

First-In-Man Clinical Use

MER® Hybrid Cells Technology- a Novel Approach for the Treatment of Carotid Artery Stenosis

First Clinical Trial to Evaluate Safety and

Feasibility of MER® stent

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

®

• 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