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July 17th, 2023

FDA updates stance on paclitaxel-coated devices to treat PAD

Cook applauds the U.S. Food and Drug Administration’s recent update on paclitaxel-coated devices. We believe this is the best decision for physicians and patients.

“We are grateful for the FDA’s latest update on paclitaxel. We applaud decisions that are based on long-term, patient-level data,” said Mark Breedlove, senior vice president of Cook Medical’s Vascular division. “Paclitaxel-coated devices, such as Cook Medical’s Zilver® PTX® Drug-Eluting Peripheral Stent, benefit millions of patients suffering from peripheral artery disease (PAD). We make data-based decisions about our procedural solutions, and we believe the FDA made the right call for patients.” 

Zilver® PTX®, Cook Medical's paclitaxel-coated stent

Zilver® PTX®, Cook Medical’s paclitaxel-coated stent

On July 11, 2023, the FDA released a long-awaited letter to healthcare providers announcing “the data does not support an excess mortality risk for paclitaxel-coated devices.”  

This announcement nullifies the FDA’s earlier recommendation that physicians use caution with paclitaxel-coated devices because of a possible unnecessary mortality risk. With this new statement the FDA agrees that paclitaxel and paclitaxel-coated devices are safe and effective for patients suffering from peripheral artery disease (PAD).  

Concerns around paclitaxel started circulating in 2018 from meta-analysis conducted by Dr. Konstantinos Katsanos, et al. The analysis suggested there was an increased mortality risk associated with paclitaxel-coated balloons.  

Understandably, the entire medical device industry became invested. A few months later, the FDA released its initial warning. Although the products from all medical device manufacturers would remain on the market, the letter said that physicians should be aware that paclitaxel could be potentially associated with increased mortality. The letter noted that Katsanos, et. al’s research should be “interpreted with caution because of multiple limitations,” but the FDA needed to do its due diligence and investigate further.  

In the spirit of transparency, Cook released five-year patient-level data from the Zilver PTX randomized control trial—and we were the first and only company to be completely transparent with our data. Zilver PTX is a drug-eluting stent indicated to treat vascular disease of the above-the-knee femoropopliteal arteries. On Cook’s website, physicians and organizations could request the de-identified patient information at no charge. We also worked tirelessly with physicians and with the FDA to understand the truth.  

In September 2019, Dr. Michael Dake, et al. published a peer-reviewed article analyzing patient-level data from two large studies with long-term follow-up to determine whether there was an increased mortality risk due to paclitaxel. The results demonstrated no increase in long-term all-cause mortality. Cook has repeatedly defended our technology with data at various conferences and in a study published in the Journal of Vascular and Interventional Radiology 

In July 2023, after a thorough investigation, the FDA released a statement saying, “Based on the FDA’s review of the totality of the available data and analyses, we have determined that the data does not support an excess mortality risk for paclitaxel-coated devices.”  

Cook will continue providing Zilver PTX. We will continue to make decisions based on evidence as the most reliable way to treat patients. We also reaffirm our commitment to transparency around data.  

To see more data on paclitaxel, Zilver PTX presentations at conferences and other related information, you can visit our paclitaxel page 

About Cook Medical
Since 1963, Cook Medical has worked closely with physicians to develop technologies that eliminate the need for open surgery. Today we invent, manufacture and deliver a unique portfolio of medical devices to the healthcare systems of the world. Serving patients is a privilege, and we demand the highest standards of quality, ethics and service. We have remained family owned so that we have the freedom to focus on what we care about: patients, our employees and our communities.

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