FDA updates recommendations on use of paclitaxel – July 2023

On July 11, 2023, the FDA sent out a letter to healthcare providers titled, “UPDATE: Paclitaxel-Coated Devices to Treat Peripheral Arterial Disease Unlikely to Increase Risk of Mortality- Letter to Health Care Providers.” The FDA has now determined the data gathered on paclitaxel-coated devices used to treat peripheral arterial disease does not support an excess mortality risk.

We spoke with Dr. Eric Secemsky about his research and work alongside both the FDA and industry and the positive impact this has on patient care.

The FDA paclitaxel notification was released on August 7, 2019, following the release of a 2018 meta-analysis.

As a result of the FDA’s letter, Cook Medical quickly released our extensive long-term data from the Zilver PTX randomized controlled trial.

Cook Medical is still providing our extensive long-term data on Zilver PTX, our drug-eluting stent. Zilver PTX is a paclitaxel-coated stent that was approved by the FDA in 2012 through the premarket approval process.

Dr. Michael Dake et al. recently published a peer-reviewed article analyzing Zilver PTX patient-level data from two large studies with long-term follow-up to determine whether there was an increased mortality risk due to paclitaxel. See the results.
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View Cook Medical’s updated letter to physicians on paclitaxel

During a June 19-20, 2019, meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee, the panel addressed concerns about the use of paclitaxel-coated devices to treat PAD. Physicians, industry leaders, professional organizations, and societies presented their findings to the panel.

At that time, the panel agreed that the benefits of paclitaxel-coated devices continued to outweigh the risks and that these devices should remain on the market.

If you have questions or would like more information on our data please visit our Cook Research Incorporated website.

RCT Data Disclosure

In the spirit of full transparency, which is a highly valued principle at Cook Medical, we were the first and only company affected by the FDA’s 2019 letter to release de-identified patient-level data. The only modifications we made to this data were designed to ensure patient privacy and confidentiality are always protected.

This Dataset includes additional vital status data for patients who did not originally complete the study. For patients who were found to have died, information on cause of death was not available; therefore, there was also no CEC adjudication or categorization possible for these patients.
This Dataset includes additional vital status data for patients who did not originally complete the study; therefore, the panel pack and panel presentation do not reflect this information.

No significant difference between Zilver PTX and PTA/BMS at 5 years.

Cook’s Presentation to FDA Advisory Panel

Presented by: Aaron Lottes, PhD, and Michael Dake, MD | June 2019

The Cook analysis of actual treatment of Zilver PTX patients included the updated status for 92% of patients who were previously lost to follow-up. The all-cause mortality rate for the PTA/BMS group was 15.6% and 18.9% for the Zilver PTX group (p-value = 0.46). The addition of the new data confirmed no mortality signal for Zilver PTX.

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