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August 7th, 2019

Cook Medical responds to updated FDA recommendations on paclitaxel-coated devices

Today, FDA updated its communication to healthcare providers on paclitaxel coated devices. Based on current information, FDA recommends that physicians discuss the risks and benefits of all available peripheral arterial disease (PAD) treatment options with patients and determine if the benefits of using a paclitaxel-coated device outweigh the risk of late mortality. To read FDA’s updated recommendations visit here.

We applaud FDA’s work in the best interest of patients. Cook is pleased that clinicians and patients will continue to have access to important technologies like Zilver PTX. We will continue to collaborate with FDA, clinicians, industry partners and medical societies to provide the data needed to make informed decisions on treatment options.

Zilver PTX is the only peripheral drug-eluting stent with long-term data. More than 300,000 Zilver PTX stents have been used over the past decade to provide a better quality of life for patients suffering from PAD. Zilver PTX has shown a sustained clinical benefit by providing greater than 40% reduction in both restenosis and reintervention through five years1.

Cook’s Presentation to FDA Advisory Panel

View Presentation

If you have questions about Zilver PTX, please contact us at, and a member of our team will respond within 24 hours. You can also visit for additional information.

  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.