5-YEAR SUPERIOR RESULTS. Compared to PTA and Zilver BMS 1. NOW WITH 140 mm LENGTH STENTS
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1 SUPERIOR 5-YEAR RESULTS Compared to PTA and Zilver BMS 1 NOW WITH 140 mm LENGTH STENTS 1. Dake MD, Ansel GM, Jaff MR, et al. Durable clinical effectiveness with paclitaxel-eluting stents in the femoropopliteal artery: 5-year results of the Zilver PTX randomized trial. Circulation. 2016;133(15):
2 SIMPLIFIED *, PRECISE ** DEPLOYMENT Single-handed thumbwheel provides simplified, precise stent deployment Paclitaxel is coated onto the Zilver Flex stent platform All-in-one Luer hub (flushing port) Available in lengths up to 140 mm Ergonomic one-handed design Drug elution Z-cell stent design Eight gold markers Electropolishing *Simplified compared to previous Zilver PTX pin-and-pull delivery system **Engineering verification testing (accuracy test of +/-3 mm; criteria met)
3 Thumbwheel Safety lock Radiopaque marker band Retraction sheath
4 PROVEN DATA 5-YEAR RESULTS % 5-YEAR PATENCY YEAR FF-TLR %.9 1* NOTE: Results are from the secondary randomization of Zilver PTX vs. Zilver bare-metal stent. 1. Dake MD, Ansel GM, Jaff MR, et al. Durable clinical effectiveness with paclitaxel-eluting stents in the femoropopliteal artery: 5-year results of the Zilver PTX randomized trial. Circulation. 2016;133(15): * The 1-year primary endpoints of EFS and primary patency showed superiority of primary DES compared to PTA, and these results were sustained through 5 years. Primary Patency is 64.0% (DES) vs. 19.0% (PTA), p<0.01. The EFS rate through 5 years for the primary DES group was significantly greater than that for PTA (Kaplan-Meier estimates 81.4% versus 70.1%, p<0.01, log-rank). The most common end to EFS through 5 years was TLR, which occurred at rates of 16.1% for primary DES and 28.0% for PTA (p<0.01). In the per-protocol analyses of EFS and TLR, the PTA group included patients with optimal PTA, patients receiving provisional BMS, and patients receiving provisional DES.
5 3 ESSENTIALS FOR ACHIEVING 5-YEAR RESULTS 1 ANTIPROLIFERATIVE DRUG: Inhibits smooth muscle cell proliferation² 2 ZILVER PTX 3 EFFICIENT DRUG DELIVERY: High tissue concentration,³ low thrombosis rates¹ VESSEL SUPPORT: Scaffolding holds back calcium, dissections, and recoil 4 2. Axel D, Kunert W, Göggelmann C, et al. Paclitaxel inhibits arterial smooth muscle cell proliferation and migration in vitro and in vivo using local drug delivery. Circulation. 1997; Jul 15;96(2): Dake MD, Van Alstine WG, Zhou Q, et al. Polymer-free paclitaxel-coated Zilver PTX Stents evaluation of pharmacokinetics and comparative safety in porcine arteries. J Vasc Interv Radiol. 2011;22(5): Litsky J, Chanda A, Stilp E, et al. Critical evaluation of stents in the peripheral arterial disease of the superficial femoral artery focus on the paclitaxel eluting stent. Med Devices (Auckl). 2014;7:
6 TIME-TESTED TECHNOLOGY 1 Zilver PTX is the first drug-eluting stent approved for the SFA. Paclitaxel inhibits neointimal hyperplasia 1 and has been proven over 5 years to reduce restenosis and reinterventions compared to bare-metal Zilver stents. 1 HOW DRUG ELUTION WORKS Release: Media Intima Stent strut > 98% of the paclitaxel coating is released from the stent within 72 hours.* 2 Cook Medical s proprietary, polymer-free coating process eliminates the potential risks associated with polymers. Smooth muscle cell Paclitaxel Absorption: Paclitaxel remains in the artery for up to 56 days.* 2 Fatty plaque Inhibiting: Cell nucleus Inside the cell, the drug binds to microtubules and inhibits mitosis. 2 Paclitaxel Microtubule *Based on pharmacokinetic studies in porcine models. 1. Dake MD, Ansel GM, Jaff MR, et al. Durable clinical effectiveness with paclitaxeleluting stents in the femoropopliteal artery: 5-year results of the Zilver PTX randomized trial. Circulation. 2016;133(15): Dake MD, Van Alstine WG, Zhou Q, et al. Polymer-free paclitaxel-coated Zilver PTX Stents evaluation of pharmacokinetics and comparative safety in porcine arteries. J Vasc Interv Radiol. 2011;22(5):
7 ORDERING INFORMATION Order Number Reference Part Number Accepts Wire Guide Diameter inch Stent Diameter mm Stent Length mm Minimum Sheath Fr 125 cm Over-the-Wire Delivery System G38463 ZISV PTX G38479 ZISV PTX G38480 ZISV PTX G38481 ZISV PTX G38482 ZISV PTX G38483 ZISV PTX G38486 ZISV PTX G38487 ZISV PTX G38488 ZISV PTX G38489 ZISV PTX G38490 ZISV PTX G38491 ZISV PTX G38495 ZISV PTX G38516 ZISV PTX G38518 ZISV PTX G38523 ZISV PTX G38532 ZISV PTX Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details. Reference Part Number Key ZISV PTX 40 = Stent Length (mm) 5.0 = Stent Diameter (mm) 80 = Introducer Length (cm) 35 = Wire Guide Diameter (.0XX inch) 6 = French Size Caution: Use of this drug-eluting peripheral stent carries the risks associated with peripheral artery stenting, including vascular complications and/or bleeding events. Refer to the Instructions for Use (IFU) for full prescribing information including information on potential adverse events, contraindications, warnings, and precautions.
8 MEDICAL COOK 03/2018 PI-D41157-EN-F
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