Proven

Long-term results delivered

Zilver PTX offers a less-invasive option for patients with life-limiting conditions associated with PAD, providing long-term clinical results compared to standard endovascular treatments¹. When compared to the competition, Zilver PTX provides:

• A reduced risk of restenosis and reinterventions with superior long-term outcomes (5 years) to standard of care (BMS)¹
• Similar primary patency, FF-TLR, amputation, and survival rates at 5-years compared to bypass while also having significantly shorter hospital stays at procedure and 30-day complications²
• Similar primary patency and CD-TLR rates in both real-world (1-year)³ and RCT (5-year)⁴ when compared to Eluvia without the concerns of permanent polymers

Proven at 5 years | Zilver PTX RCT

Proven against bypass | ZILVERPASS 5-year results

The ZILVERPASS objective was to evaluate the performance of Zilver PTX compared to prosthetic bypass surgery for the treatment of femoropopliteal TASC C & D lesions. The RCT included an economic analysis at 36 months and a final clinical publication  at 60 months.

A bold decision: The Zilver PTX randomized controlled trial was designed from the start to include 5-year follow-up data that would determine not only long-term benefits but also long-term safety signals or adverse events.

Compared to patients who underwent prosthetic bypass surgery, Zilver PTX patients had:

• Significantly shorter hospital stays at procedure⁷

• Significantly fewer complications through 30 days⁷

• Similar survival rate through 5 years²

Economic analysis (US)

The economic analysis, taking into account procedural, hospitalization, and reintervention costs, showed a clear cost-benefit for Zilver PTX, in the USA reimbursement model.⁸

Conclusion: These final 5-year results unequivocally establish the non-inferiority of the Zilver PTX stent compared to above-the-knee prosthetic bypass surgery, underscoring their comparable effectiveness and safety profiles.²

Proven in a broad range of lesions

*Subgroup of patients for the Zilver PTX single arm study. Long lesion group was 135 lesions that were > 15 cm, corresponding to TASC C or D. Results from a non-pre-specified post-hoc analysis.

Note: CTO = Chronic Total Occlusion; PSVR = Peak Systolic Velocity Ratio.

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. 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
3. Shibata T, Iba Y, Shingaki M, et al. One year outcomes of Zilver PTX versus Eluvia for femoropopliteal disease in real-world practice: REALDES study. J Endovasc Ther. 2025;32(2):490–497.
4. Gray W. CRT-300.01. Five-year results from the IMPERIAL randomized study of Eluvia and Zilver PTX drug-eluting stents and the long lesion sub-study for femoropopliteal artery disease. J Am Coll Cardiol Intv. 2023;16(4 suppl):S55.
5. 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.
6. Dake MD, Ansel GM, Jaff MR, et al. Sustained safety and effectiveness of paclitaxel-eluting stents for femoropopliteal lesions: 2-year follow-up from the Zilver PTX randomized and single-arm clinical studies. J Am Coll Cardiol. 2013;61(24):2417–2427.
7. Bosiers M, Setacci C, De Donato G, et al. ZILVERPASS Study: Zilver PTX stent vs bypass surgery in femoropopliteal lesions. J Endovasc Ther. 2020;27(2):287–295.doi:10.1177/1526602820902014
8. 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;64:413–421.
9. Yokoi H, Ohki T, Kichikawa, K, et al. Zilver PTX post-market surveillance study of paclitaxel-eluting stents for treating femoropopliteal artery disease in Japan: 12-month results. J Am Coll Cardiol Intv. 2016;9(3): 271-277.
10. Bosiers M, Peeters P, Tessarek J, et al. The Zilver PTX single arm study: 12-month results from the TASC C/D lesion subgroup. J Cardiovasc Surg (Torino). 2013;54(1):115–122.