size matrix / ordering information enhanced performance
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ENHANCED PERFORMANCE
Sirolimus Coated Balloon
ENHANCED Drug
Delivery
ENHANCED Device
Delivery
Clinical outcomes in Challenging lesions*
BDEV001_EN_Rev21023
STENTYS S.A.17-19, Avenue de la Métallurgie93210 Saint Denis La Plaine FranceTel: +33 1 44 53 99 42Fax: +33 1 44 53 99 24www.stentys.com
Envision Scientific Pvt. Ltd.Plot C1B-108, Ichchhapore GIDC Industrial Estate,Bhatpore, Sachin-Hazira Road,Surat 394 510 GUJ-INDIA
Distributed by Minvasys
Size Matrix / Ordering Information
1.50 2.00 2.25 2.50 2.75 3.00 3.50 4.00
10 CDE15010 CDE20010 CDE22510 CDE25010 CDE27510 CDE30010 CDE35010 CDE40010
15 CDE15015 CDE20015 CDE22515 CDE25015 CDE27515 CDE30015 CDE35015 CDE40015
20 CDE15020 CDE20020 CDE22520 CDE25020 CDE27520 CDE30020 CDE35020 CDE40020
25 CDE15025 CDE20025 CDE22525 CDE25025 CDE27525 CDE30025 CDE35025 CDE40025
30 CDE15030 CDE20030 CDE22530 CDE25030 CDE27530 CDE30030 CDE35030 CDE40030
35 CDE15035 CDE20035 CDE22535 CDE25035 CDE27535 CDE30035 CDE35035 CDE40035
40 CDE15040 CDE20040 CDE22540 CDE25040 CDE27540 CDE30040 CDE35040 CDE40040
Diameter in mm
Leng
th in
mm
Delivery System & Specifications
Drug Sirolimus
Drug dose 1.27 µg/mm2
Drug carrier Phospholipid based carrier (BioSphere)
Balloon material Polyamide blend (semi compliant balloon)
Catheter design Rapid Exchange design
Shaft diameter – Proximal 1.7 F
Shaft diameter – Distal 2.5 F
Usable catheter length 140 cm
Tip profile 0.016”
Nominal pressure 6 atm
Rated burst pressure 16 atm (14 atm for 4.00 / 25 to 40 mm)
Guiding catheter compatibility 5F (0.056’’ ID) for all sizes
Guidewire compatibility 0.014’’ maximum recommended
*Data on file at Stentys
12 months Results of Devoir Registry
2.00%
0.00%
4.00%
6.00%
8.00%
10.00%
12.00%
14.00%
MACE*
CARDIAC DEATH*
TLR*
MI*
In Stent Restenosis 6.2% MACE At 12 months*
Composite of Cardiac Death, TLR and MI
Small Vessell Disease 4.1% MACE At 12 months*
Composite of Cardiac Death, TLR and MI
incorporating
412284 STENTYS Devoir brochure 4pp v3.indd 1-2 20/12/2018 15:02
ENHANCED DCB PERFORMANCEEnhanced Device Delivery
Enhanced Drug Delivery
Thanks to a performant platform with ultra low crossing and tip profiles, Devoir is able to tackle even the most distal and tortuous lesions. Enhancing your device delivery and giving you confidence in reaching the lesion.
Thanks to the combination of both BioSphere and Sirolimus, Devoir ensure an homogenous distribution of drug, in length, circumference and depth over time. Enhancing your drug delivery and giving you the
confidence that the lesion has been uniformly treated.
Optimal adherence of Devoir coating
results in minimal drug loss during delivery, ensuring that Sirolimus is
uniformly delivered along the length of the lesion.
Unlike some DCBs, Devoir is coated before folding leading to a
uniform distribution of Sirolimus on the full circumference of the balloon,
making sure that the lesion has a homogeneous distribution of drug both in
length and diameter.
Thanks to its small size BioSpheres and to the Sirolimus action, Devoir has also demonstrated an
effective and homogeneous drug distribution from intima to adventitia within 7 days.
ULTRA LOW CROSSING PROFILE
0.85 mm
IN LENGTH
TIP PROFILE
0.016 inch
IN DIAMETER
HIGHLY PERFORMANT
DELIVERY PLATFORM
IN DEPTH
BioSphereBilayered Phospholipids
Phospholipid
Sirolimus
LUMEN
ENDOTHELIUM
INTIMA
MEDIAADVENTITIA
DEVOIR COATING PROCESS
DEVOIR IS COATED BEFORE FOLDING TO ALLOW A
UNIFORM DISTRIBUTION OF SIROLIMUS
412284 STENTYS Devoir brochure 4pp v3.indd 3-4 20/12/2018 15:02
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