Long-awaited US FDA update on paclitaxel-coated devices - Caitlin Hicks

In a letter to healthcare providers dated 11 July 2023, the US Food and Drug Administration (FDA) communicates that the risk of mortality associated with paclitaxel-coated devices to treat peripheral arterial disease (PAD) is no longer supported based on data and analyses.

This update signals a lowering of the red flag raised in a 2019 letter from the Administration—published in response to a meta-analysis that indicated a late mortality signal—warning that treatment of PAD with paclitaxel-coated balloons and paclitaxel-eluting stents was “potentially associated with increased mortality”.

Alongside the letter, the US FDA has updated its recommendations for healthcare providers regarding the use of paclitaxel-coated balloons and stents for PAD. As well as removing reference to the possibility of increased mortality with these devices, the amended guidance softens the language around the monitoring of patients who have been treated with paclitaxel-coated stents and balloons, stating that healthcare providers should continue ‘routine’ rather than ‘close’ monitoring of these patients, as had previously been stated.