First clinical cases

32 Patients with high risk carotid artery lesions

12 months results

Prof. Grzegorz OszkinisPoznań (Poland) experience

More than 70% of events

after the procedureS occur

M.Bosiers

Causes of Late Embolization

Prof. Dr. Klaus Mathias, TCT 2013

• Insufficient coverage• Thrombus formation

3

MICROMESH CAROTID

stents

Page 43ROADSAVER

GORE CAROTID STENT

RoadSaver Carotid Stent

•double layer micromesh scaffold

- enabling sustained embolic protection by very tight plaque coverage

• embolic protection starts with implantation of the stent into the lesion and continues throughout the process of neointimalization

•up to 50% deployment full re-sheathable andrepositionable

Sustained Embolic Protection

•Smallest stent cell size -preventing emboli release

Tacks down/contains plaque, acting like a metallic covered stent

•Plaque coverage

Characterizes how tight the stent cells cover the plaque material, protecting it from dislodging, prolapsing/ embolizing

7

Roadsaver Stent A Stent B

Stent C Stent D Stent E

Cell Size Comparison

Micromesh(375-700 µm)

• Lesion specific scaffolding

9

•Wall apposition

The way how stent struts conform to the vesselmorphology, in combination with the radial force

(e.g. eccentric plaque: struts should not leave any dead-water zones between vessel wall and stent struts

increased thrombogenicity)

RoadSaver Carotid Stent

• 5Fr Rapid Exchange delivery system

Low profile enhances the crossability for primary stenting

• Push-Pull Stent Delivery System

For re-sheathing, a push-pull handle is necessary

• No tapered version needed

Due to the braided mesh double layer design in Nitinol, the stent nicely tapers according to the anatomy, without overstretching the vessel wall

Deployment Recapture

omeshStent Selection including MicrType Open Cells Stent Closed Cells Stent Micromesh

Name

Comp

Precise

CordisProteg

EV 3

Wallstent

BSCAdapt

BSC

Xact

Abbott

Roadsaver

TerumoCguard

Inspire

Sympto + ± +++ +++? ++ +++ +++

Asymp. +++ ++ + ++ ++ +++ +++

Bifurc. ++ +++ +++ + ± +++ +

Ulcerate ++ ++ +++ ++? +++ +++ +++

Calcifie ++ ++ + ++ +++ + ++

Short +++ +++ - ++ +++ + +++

Long ++ ++ +++ ++ + +++ +

Accurac +++ ++ + ++ +++ + +++

Irr/Coni + +++ +++ ++ +++ ++ +

Restenosis +++ +++ +++ +++ +++ +++ +++

Radioth ++ ++ +++ - +++ +++ +

Company Microvention /Terumo Inspire MD WL Gore

Material

(Stent/Micromesh)

Nitinol /Nitinol Nitinol/PET Nitinol/PTFE/

CBAS Coating

Size of delivery 5F 6F 6F

Size of Pores µ 375-500 150-180 500

Flared tips yes no no

Retrievable/Reposit

ionable

yes no no

Accuracy ++ +++ +++

Conformability +++ ++ ++

Crossability +++ ++ ++

ECA preservation yes yes Yes

EPD compatibility All All All

Summary of the main characteristic of the 3 MICROMESH stents

CGuard™ Gore CarotidRoadsaver

Details of procedure

DAPT before : All

31 Men , 9 Women : From 53 y to 85 y

1 Women : 2 stents

Asymptomatic : ALL

Sedation : NO

Femoral Approach : All

FILTER Protection : ALL

Atropine before inflation : All

Post-Dilatation : All

%N=40 Number

Procedural Events

Myocardial Infarction 0 0%

Stroke (Stent Thrombosis) 1 2,4%

Neurological Death 0 0%

30-Day Events

Myocardial Infarction 1 2,4%

Neurological Death 0 0%

Stroke 0 0%

Total

Neurological Death/Stroke/MI 2 4,8%

Procedural and 30 day Results

%N=32 Number

12 - monthsMyocardial Infarction 0 0%

Neurological Death 0 0%

Stroke 0 0%

Total after 12 months

Neurological Death/Stroke/MI 2 4,8%

12 - months Results

Asymptomatic CASRoadSaver 7x30

Asymptomatic CASRoadSaver 7x30

Plaque coverage

scaffolding

Goal: sustained embolic protection by preventing emboli release

RoadSaver 7x25

Absolute contraindications

Occluded ICA

Visible thrombus

18

CASRoadsaver 6x30

6F Destination .014 choice PT RoadSaver PTA 5x30

Roadsaver 8x30

Unmatched clinical needs?

•The ECA remains patent @ 6months !

ICAECA