ENHANCED PERFORMANCE Sirolimus Coated Balloon ENHANCED Drug Delivery ENHANCED Device Delivery Clinical outcomes in Challenging lesions * BDEV001_EN_Rev2 1023 STENTYS S.A. 17-19, Avenue de la Métallurgie 93210 Saint Denis La Plaine France Tel: +33 1 44 53 99 42 Fax: +33 1 44 53 99 24 www.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 Length in mm Delivery System & Specifications Drug Sirolimus Drug dose 1.27 µg/mm 2 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