Paclitaxel Data Presented at CIRSE Confirms Safety of Zilver® PTX®

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Michael D. Dake, MD, presented at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) conference regarding new data on the use of Zilver® PTX®, Cook Medical’s paclitaxel-coated stent for peripheral arterial disease (PAD).

Dr Dake is the senior vice president of health sciences at the University of Arizona, Tucson, and is president-elect of the Society of Interventional Radiology Executive Council. At CIRSE, Dr Dake presented new 5-year data on Zilver PTX that Cook Medical gathered from the randomized controlled trial (RCT) performed to obtain FDA approval. Dr Dake was also the global principal investigator for the study.

Cook Medical is the only organisation that has publicly provided long-term, patient-level data on the use of paclitaxel-coated devices for PAD. In addition to previously released information, the presentation included new data that had not been previously published. This new data includes information from patients who had not previously completed the study, such as those who had been lost to follow up, giving a more complete view of how paclitaxel-coated devices affect patients. The data confirms no significant difference in all-cause mortality for the Zilver PTX drug-eluting stent compared to traditional angioplasty or a bare metal stent (BMS). The findings further show that treatment with Zilver PTX and paclitaxel dose were not predictors of mortality. However, age and other serious conditions common in PAD patients were associated with mortality.

The findings that Dr Dake presented have been published online in CardioVascular and Interventional Radiology (CVIR), a peer-reviewed journal. You can read the publication here.

“Our clinical program evaluates the Zilver PTX technology across a broad, real-world patient population—including patients at high risk for restenosis and reintervention. Zilver PTX offers proven long-term benefits that help patients get back to living,” said Mark Breedlove, vice president of Cook Medical’s Vascular division.

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