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