Making Sizing Easier

SV
s
G
the only
self-apposing®
stent
LAR
G
E
SSELS
VE
NEW Indications
NEW Results in STEMI
BIFUR
C
A
N
IO
T
ECTATIC V
E
LS
SE
S
PERING V
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EL
S
MAKING
SIZING EASIER...
MAKING SIZING EASIER...
Which stent size?
3.0? 3.5?
3.0
3.5
Malapposition,
Underexpansion
Overdilation
Stent
thrombosis
Restenosis
Dissection/
Perforation
No reflow
THE SELF-APPOSING® STENTYS BMS & DES(P) STENTS
1
One stent size provides a range of vessel diameters making
sizing easier when the actual diameter is obscured (eg. in STEMI)
2
The stent adapts itself to the shape of the natural artery and
can expand to different diameters at distal and proximal points,
so is well-apposed to tapering vessels or aneurysms
3
The stent has disconnectable interconnections between struts
which create access to the sidebranch if required.
4
The stent can continue to expand after deployment in case of
vasodilation, thrombus resolution or positive remodelling over
time
CHOOSE THE SELF-APPOSING ® STENT!
APPOSITION III REGISTRY - 1 YEAR RESULTS IN 965 STEMI PATIENTS1
20
Cumulative event rate (%)
Cardiac Death at 1 year
MACE at 1 year
18
16
8%
14
7%
12
6%
MACE : 9.3%
10
5%
8
3.9 %
4%
6
3%
Cardiac death or TV-MI : 3.2%
4
2.0 %
2%
2
Cardiac death : 2.0%
1%
0
R
O
E
E
X
H
A
M
IN
Time since STENTYS placement (months)
P
A
S
12
O
10
N
8
M
6
A
T
IO
4
K
O
2
E
BMS / DES use in population: 74% / 26%
M
R
U
IZ
LT
O
IS
N
T
S
R
A
T
E
G
O
Y
N
-T
IM
E
2
TA
P
A
T
S
Y
P
H
O
O
N
P
A
S
W
S
ei
IO
gh
N
te
d
m
ea
n
A
P
P
O
S
IT
IO
N
III
0%
0
Importance of Post-Dilatation*
Results at 1 year
With
post-dilatation
Without
post-dilatation
P-value
Cardiac death/TV-MI
2.4%
5.0%
0.03
Definite Stent
Thrombosis
1.9%
5.0%
0.01
* ONLY 2.4% CARDIAC DEATH /TV-MI AT 1 YEAR WHEN POST-DILATATION WAS PERFORMED
DEPLOYING A STENTYS STENT
1 The Self-Apposing® STENTYS
Stent is positioned over the
lesion before deployment.
2 The STENTYS Stent is
deployed from distal to
proximal by retracting the
outer sheath.
3 The STENTYS Stent is fully
deployed in the artery of
the patient. Post-dilatation
is recommended to ensure
adequate stent expansion.
OPTIONAL DISCONNECTION AT A SIDEBRANCH
1 Position the guidewire into
the side-branch through
the stent cell closest to the
carina.
2 Inflate a regular PTCA balloon
at low pressure (8atm) at
the side-branch opening to
disconnect the struts.
4 The STENTYS Stent
expands with the vessel
during vasodilation and as
thrombus resolves.
Only 3.7%
TLR at 6
months in
bifurcations2
3 Stent interconnectors
separate due to the
combined effect of flexion
and torsion created by the
balloon.
4 Deflate and withdraw the
1.
Pooled analysis by the ACTION study Group at Pitié-Salpêtrière Hospital (www.action-coeur.org - Prof. G. Montalescot)
1 year results presented at ACC.13 by Prof. Gilles Montalescot
2.
Results of DES(P) arm in OPEN I trial - S. Verheye et al., Eurointervention 2011;7:580-587
balloon allowing the stent to
expand fully. This creates an
opening to the side- branch.
Final kissing balloon is not
required.
STENTYS BMS and DES(P)
ORDERING CODES
BMS
THE SELF-APPOSING
Indicated Vessel
TM
DES
(P)
STENT
T H E S E L F - A P P O S I N G TM S T E N T
Stent nominal length
Diameter (mm)
17mm
Side-branch
Stent nominal length
22mm
27mm
17mm
22mm
27mm
diameter (mm)
≥ 2.20
2.5-3.0 (Small)
STY00-2530-17
STY00-2530-22
STY00-2530-27
STY01-2530-17
STY01-2530-22
STY01-2530-27
3.0-3.5 (Medium)
STY00-3035-17
STY00-3035-22
STY00-3035-27
STY01-3035-17
STY01-3035-22
STY01-3035-27
≥ 2.25
3.5-4.5 (Large)
STY00-3545-17
STY00-3545-22
STY00-3545-27
STY01-3545-17
STY01-3545-22
STY01-3545-27
≥ 2.50
SELF-APPOSING® TECHNOLOGY*
B
A
D
C
145cm
* Indicated vessel diameter
** Approximate length when expanded at indicated vessel diameter
A - The STENTYS Stent is a self-expanding, nitinol, bare-metal or drug-eluting (Paclitaxel) stent.
B - The catheter is a rapid-exchange, single-wire system with hydrophilic coating.
C - Guidewire compatibility: 0.014’’ (0.35mm). Guiding catheter compatibility: 6F (2.0mm).
D - Deployment handle with retractable trigger.
Strut width: 68µm (0.0027’’)
Stent recoil: 0%
*Technical data from STENTYS
DISCONNECTION TECHNOLOGY
The Self-Apposing® STENTYS Stent has disconnectable interconnections between struts which create access to
the sidebranch if required.
Disconnectors
along the stent
Disconnector
Disconnection
The STENTYS stents are CE marked when intended for improving coronary luminal diameter in the treatment of
ACS, de novo lesions, in vessels involving a sidebranch (bifurcation) or with diameter variations (e.g. tapered ectatic),
in native coronary arteries and coronary bypass grafts (CABG).
CAUTION: Indications, contraindications, warnings and instructions for use can be found in the product leaflet supplied with the device.
Not available for sale in the United States.
© STENTYS S.A. 2013
STENTYS S.A.
25, rue de Choiseul
75002 Paris
France
Tel: +33 1 44 53 99 42
Fax: +33 1 44 53 99 24
STY-SIZ-130514
www.stentys.com