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March 7th, 2024

MHRA Updates Advice on Paclitaxel-Coated Devices

On 5 February, the Medicines and Healthcare products Regulatory Agency (MHRA) made a critical announcement: the agency updated their guidance on the use of paclitaxel-coated devices (PCDs).  

After carefully reviewing available evidence and receiving input from an independent expert working group, the MHRA updated their previous advice on PCDs to remove restrictions on indication, dose, and repeated exposure. This meant withdrawing its previous advice to use the lowest dose PCDs available and to avoid/reduce repeated exposure of paclitaxel coated devices is withdrawn.

Cook Medical's Zilver PTX product

Cook Medical’s Zilver PTX product

Additionally, they affirmed that “where indicated, PCD can be considered a treatment option in patients with critical limb ischaemia (CLI) or intermittent claudication (IC).” 

In July 2023, the U.S. Food and Drug Administration (FDA) concluded there is no increased mortality risk for paclitaxel devices. Additionally, Health Canada and the Therapeutic Goods Association (TGA) of Australia have concluded there is no increased risk of mortality associated with the use of paclitaxel devices. Each of these organizations made their decision following review of available evidence, including an updated meta-analysis of the randomized studies, which Cook supported. Cook Medical applauds the updates from all of these regulatory agencies. We believe these updates are in the best interest of both physicians and patients. 

“We are grateful for the MHRA’s latest update on paclitaxel. They carefully reviewed the data, and they did so with patients’ best interests in mind,” 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 worldwide who are suffering from peripheral artery disease (PAD). We make data-based decisions about our procedural solutions, and we believe the MHRA has made the correct decision in lifting the restrictions.”   

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

Understandably, the entire medical device industry became invested. A few months later, the United States Food and Drug Administration (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 from multiple regulatory organizations to understand the truth.   

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.