A proven history of innovation – Zilver^® PTX^®

Our mission with Zilver PTX—and with every product we make at Cook Medical—is to try to improve patients’ lives. We have released extensive data around Zilver PTX, and this device continues to show benefits across a wide spectrum of patients.

Only Zilver PTX combines the antiproliferative drug paclitaxel with efficient, polymer-free drug delivery and vessel support to demonstrate superior 5-year results against percutaneous transluminal angioplasty (PTA) and Zilver bare-metal stents.

Evaluating the performance of the Zilver PTX drug-eluting stent vs. bypass surgery for the treatment of femoropopliteal TASC C&D lesions²

Economic Analysis (US)

Final 36-month results show at least a non-inferiority of Zilver PTX vs. prosthetic bypass surgery ATK with³:

Economic analysis, taking into account procedural, hospitalization, and reintervention costs, showed a clear cost-benefit for Zilver PTX, both for the Germany and USA reimbursement models.³

Additional resources

• Zilver PTX product page
• Zilver PTX brochure
• Thumbwheel animation
• Zilver PTX: Transparency, data, and patient safety (Update)
• The Zilver PTX Single-Arm Study
• Zilver PTX results for diabetic and nondiabetic patients
• Short-term paclitaxel delivery in the SFA has been proven beneficial
• Zilver PTX vs. Eluvia drug and stent technology
• Load and exposure time for paclitaxel-coated devices in the SFA
• Watch Dr. Charles Bailey discuss Zilver PTX global data overview

References

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):1472-83.
2. Bosiers MJ, De Donato G, Torsello G, et al. ZILVERPASS study: ZILVER PTX stent versus prosthetic above-the-knee bypass surgery in femoropopliteal lesions, 5-year results. Cardiovasc Intervent Radiol. 2023 Sep 5. doi: 10.1007/s00270-023-03549-0. Epub ahead of print. PMID: 37670198.
3. Bosiers M, De Donato G, Torsello G, et al. ZILVERPASS study: ZILVER PTX stent vs. bypass surgery in femoropopliteal lesions, 3 year results and economic analysis. J Cardiovasc Surg. 2023;64:413-21. doi: 10.23736/S0021-9509.23.12607-3
4. 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):636-45.
5. 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):603-610.
6. 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;7:149-156.
7. Torii S, Yahagi K, Mori H, et al. Biologic drug effect and particulate embolization of drug-eluting stents versus drug-coated balloons in healthy swine femoropopliteal arteries. J Vasc Interv Radiol. 2018; 29(7):1041–1049.
8. Gray W. Twelve-month results of the IMPERIAL randomized trial comparing the Eluvia and Zilver PTX stents for treatment of femoropopliteal arteries. Presented at: TCT; September 22, 2018; San Diego, CA.
9. Abizaid A, Costa R Jr. New drug-eluting stents: An overview on biodegradable and polymer-free next-generation stent systems. Circ Cardiovasc Interv. 2010 Aug;3(4):384-93.
10. Dake MD, Ansel GM, Bosiers M, et al. Paclitaxel-coated Zilver PTX drug-eluting stent treatment does not result in increased long-term all-cause mortality compared to uncoated devices. Cardiovasc Intervent Radiol. 2020;43:8–19.
11. Dake MD, Fanelli F, Lottes AE, et al. Prediction model for freedom from TLR from a multi-study analysis of long-term results with the Zilver PTX Drug-Eluting Peripheral Stent. Cardiovasc Intervent Radiol. 2020. https://doi.org/10.1007/s00270-020-02648-6. [e-published ahead of print]
12. Kichikawa K, Ichihashi S, Yokoi H, et al. Zilver PTX post-market surveillance study of Paclitaxel-eluting stents for treating femoropopliteal artery disease in Japan: 2-year results. Cardiovasc Intervent Radiol. 2019 Mar;42(3):358-364. doi: 10.1007/s00270-018-2110-1.
13. Dake MD, Scheinert D, Tepe G, et al. Nitinol stents with polymer-free paclitaxel coating for lesions in the superficial femoral and popliteal arteries above the knee: twelve-month safety and effectiveness results from the Zilver PTX single-arm clinical study. J Endovasc Ther. 2011 Oct;18(5):613-623. doi: 10.1583/11-3560.1. 
14.  Cipollari S, Yokoi H, Ohki T, et al. Long-term effectiveness of the Zilver PTX Drug-Eluting Stent for femoropopliteal peripheral artery disease in patients with no patent tibial runoff vessels: results from the Zilver PTX Japan post-market surveillance study. J Vasc Interv Radiol. 2018 Jan;29(1):9-17.e1. doi: 10.1016/j.jvir.2017.08.014.