Safe

Zilver PTX is safe and effective for treating PAD 

Zilver PTX remains the only SFA DES with a transparent 5-year safety profile.

The safety and efficacy of paclitaxel has been rigorously studied by leading physicians and industry partners like Cook. Immediately following the paclitaxel controversy we began thoroughly evaluating our data and in the spirit of transparency released five-year patient-level data from the Zilver PTX randomized control trial. After this rigorous analysis, we concluded there was no increased risk of mortality associated with Zilver PTX.

We were the first and only company to be this transparent with our data. 

We have remained dedicated to the safety and efficacy of Zilver PTX and will continue to deliver this proven technology to patients around the world. Zilver PTX has repeatedly achieved long-term success, out to 5-years, and sustained durability^1,2,3 with consistently low fracture rates in randomized trials^1,4 and remains the only polymer-free drug-eluting stent for the SFA. Our proprietary, polymer-free coating process eliminates the potential risks of permanent polymers. When placing a drug-eluting stent you can feel confident Zilver PTX improve long term outcomes for your patients.

This comprehensive look at paclitaxel has led the FDA to update their stance and to confirm there is no excess mortality risk for paclitaxel-coated devices. This update allows Zilver PTX to be available for all PAD patients instead of only those considered high risk. 

You can learn more about the FDA decision and Cook’s stance here. You can also read about Dr. Eric Secemsky’s involvement in researching paclitaxel, industry collaboration, and the importance of drug coated devices to patient safety. 

For some, controversies surrounding the use of paclitaxel-coated devices to treat PAD in the SFA have caused concern about patient safety. Transparency is the key to ensuring physicians have access to the safest and most effective technology available for treating PAD in a broad patient population. That’s why we took the unprecedented step of making our 5-year patient-level data fully available for the whole world to see. Our commitment to data transparency led to the creation of our exclusive prediction model.

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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):1472-1483.
2. Sugimoto M, Komori K, Yokoi H, et al. Long-term effectiveness of a drug-eluting stent for femoropopliteal in-stent restenosis: sub-analysis of the Zilver PTX Japan post-market surveillance study. J Endovasc Ther. 2021;28:229-235. doi: 10.1177/1526602820966708.
3. 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. 2024;46(10):1348–1358. doi.org/10.1007/s00270-023-03549-0
4. Gray W. A polymer-coated, paclitaxel-eluting stent (Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX) for endovascular femoropopliteal intervention (IMPERIAL): a randomized, non-inferiority trial. Lancet.2018; 392:1541-1551. http://dx.doi.org/10.1016/S0140-6736(18)32262-1
5. 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(1):8-19.
6. 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.
7. Dake MD, Ansel GM, Jaff MR, et al.; Zilver PTX Investigators. Paclitaxel-eluting stents show superiority to balloon angioplasty and bare metal stents in femoropopliteal disease: twelve-month Zilver PTX randomized study results. Circ Cardiovasc Interv. 2011;4:495–504.
8. 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;42(3):358–364. doi: 10.1007/s00270-018-2110-1.
9. 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;18(5):613–623. doi: 10.1583/11-3560.1.
10. 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;29(1):9–17.e1. doi: 10.1016/j.jvir.2017.08.014.
11. 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.