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Peripheral Intervention
September 20th, 2017

FDA approves two-year shelf life for Zilver® PTX®


Zilver PTX, the world’s first drug-eluting stent for treatment of vascular disease in the superficial femoral artery (SFA), has received two-year shelf life approval from the FDA in the U.S. An extended shelf life reduces the occurrence of expired product and decreases financial risk to the hospital.

It is only one of the recent FDA approvals granted to Zilver PTX. In addition to a new, longer shelf life, Zilver PTX is now FDA-approved to treat total lesion lengths up to 300 mm per patient.

Zilver PTX has continued to expand its revenue-based market share among all competitive SFA stents and has held the market-leading position for SFA stents in the U.S. since 2015.1

Zilver PTX is the only drug-eluting SFA stent with five-year published data. Results from the 479-patient multicenter, prospective, randomized study showed that, after five years, provisional Zilver PTX maintained 72% primary patency compared to 53% percent patency for patients who received provisional Zilver bare-metal stent placement.2

Refer to the Zilver PTX product page for the complete Instructions for Use.

1 © 2016 Millennium Research Group, Inc. All rights reserved. Reproduction, distribution, transmission or publication is prohibited. Reprinted with permission.
2 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.