UK medtech regulators on Monday announced that manufacturers of paclitaxel-eluting balloons for use in peripheral arteries must add a warning label about the devices’ risks.
A meta-analysis published in the Journal of the American Heart Association in 2018 suggested that patients treated with paclitaxel-coated balloons and stents for peripheral artery disease could be at a higher risk for late death compared to people treated with uncoated balloons. Led by Dr. Konstantinos Katsanos, researchers looked at data from 28 trials and discovered that there was a 68% relative risk increase in all-cause death with paclitaxel-coated devices after 5 years and a 93% relative risk after 5 years compared to therapy with an uncoated balloon.
Labeling changes will apply to instructions for use of these devices throughout Europe and will include a warning and a summary of the Katsanos publication plus supplemented with the clinical data specific to each device. No devices are being recalled.
The FDA said in August 2019 that it wants more long-term safety and effectiveness studies done on paclitaxel-eluting stents and balloons, and urged physicians to carefully consider when to use them. In a letter to healthcare providers, the agency recommended discussing the risks and benefits of the devices with patients and continue “diligent monitoring” of patients who have been treated with them.