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Explore our results

Select a Zilver PTX result you’d like to explore.

Predictable:

Proven:

Long-term results promised and delivered.

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.

The Results

NOTE: Results are from the secondary randomization of ZIlver PTX vs. Zilver bare-metal stent.

See More Resources

• Zilver PTX global data analysis reveals proven long-term benefit, real-world outcomes.
• VIVA presentation supports Zilver PTX benefits across different patient groups.
• Zilver PTX drug-eluting stent study data show continued patency at five years.

Safe:

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

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.

See more safety information

See more of our updates on Zilver PTX global patient safety data.

Durable:

Zilver PTX offers the best SFA DES fracture rates^1,6

The Zilver Flex platform has demonstrated fracture-resistant design through five years and has also demonstrated a lower fracture rate than the Eluvia DES.

The Zilver PTX randomized trial

The Imperial randomized trial 1-year fracture rates

Innovative:

Polymer-free drug delivery that’s ahead of its time⁷

Only Zilver PTX combines an antiproliferative drug with efficient, polymer-free drug delivery and vessel support to demonstrate superior 5-year results against PTA and Zilver bare-metal stents.

When drug elution is most needed:

Short-term paclitaxel delivery in the SFA has been proven beneficial.

How drug elution works:

Zilver PTX is the only polymer-free SFA drug-eluting stent. Our proprietary, polymer-free coating process is shown to be safe and effective while eliminating the potential risks associated with permanent polymers.

Broad offering:

Zilver PTX offers twice the number of sizes and a longer indication than Eluvia.

Our paclitaxel history:

Cook Medical’s 25-Year History with Paclitaxel

Zilver PTX started in the coronary and landed in the SFA.

15 years of global studies

• > 1,000 patients included in pre-market clinical studies to support US regulatory approval.
• > 2,500 patients included in pre- and post-market clinical studies.
• > 300,000 Zilver PTX stents used to treat patients suffering from PAD.
• Tested in a broad range of lesions.

Patient education:

More resources

• Zilver PTX product page
• Zilver PTX brochure
• Thumbwheel animation
• 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

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. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.
9. 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]