UPDATE: Paclitaxel-Coated Devices to Treat Peripheral Arterial Disease Unlikely to Increase Risk of Mortality - Letter to Health Care Providers

The U.S. Food and Drug Administration (FDA) is informing health care providers about updated information associated with paclitaxel-coated devices used to treat peripheral arterial disease (PAD).

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. The FDA previously communicated about this topic in 2019 and is now providing updated information.

Recommendations for Health Care Providers

• Discuss the risks and benefits of all available PAD treatment options, including paclitaxel-coated devices, with your patients.
• Continue routine monitoring of patients treated with paclitaxel-coated balloons and paclitaxel-eluting stents.
• Ensure patients receive optimal medical therapy for PAD and other cardiovascular risk factors as well as guidance on healthy lifestyles including weight control, smoking cessation, and exercise.
• Report any adverse events or suspected adverse events to the FDA.

Additional Clinical Evidence for Paclitaxel-Coated Devices

Since the Circulatory System Devices Panel of the Medical Devices Advisory Committee meeting [1] and the FDA's Letter to Health Care Providers on August 7, 2019, additional data from the pivotal randomized controlled trials (RCTs) has become available. The FDA has worked with device manufacturers and external stakeholders to develop the protocol and analysis plan for new data generation.

Device manufacturers collaborated in an updated meta-analysis, which included additional studies, more complete vital status information, and longer-term follow-up compared to prior studies. In these studies, patient follow-up ranged from 2 to 5 years, with data from most studies available out to 5 years. FDA clinicians and statisticians reviewed the study data and concluded that the updated RCT meta-analysis does not indicate that the use of paclitaxel-coated devices is associated with a late mortality risk.

The FDA also reviewed additional analyses of the risk for late mortality, including the SWEDEPAD trial interim analysis [2], the VOYAGER PAD study [3], the German BARMER Health Insurance study [4], the U.S. Veterans Health Administration study [5], and the Medicare SAFE-PAD study [6]. None of these studies, with mean or median follow-up ranging from 1.7 to 3.5 years, found a risk for late mortality associated with paclitaxel-coated devices.

Longer-term follow-up in several of these studies is ongoing.

This issue applies to all paclitaxel-coated devices, including all models, lots, and unique device identifiers.

FDA Actions

The FDA will work with device manufacturers to update product labeling based on the current available data.

The FDA will continue to monitor the post-market performance of this product class and keep the public informed if there are any new recommendations on the FDA's Paclitaxel-Coated Balloons and Stents for Peripheral Arterial Disease web page.

Reporting Problems to the FDA

The FDA encourages health care providers to report any adverse events or suspected adverse events experienced with paclitaxel-coated devices.

• You can submit voluntary reports through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
• Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations.
• Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

By promptly reporting adverse events, you can help the FDA identify and better understand the risks associated with medical devices.

Contact Information

If you have questions about this letter, contact the Division of Industry and Consumer Education (DICE).

Read the full alert.