17 January 2019 - Today the FDA issued a letter to health care providers about a recent publication in the Journal of the American Heart Association that suggests a possible increased risk of death at two years and beyond in patients with a type of peripheral arterial disease who were treated with vascular balloons coated with a drug called paclitaxel or stents that release paclitaxel in the femoropopliteal artery in the leg, compared to patients treated with control devices (non-coated balloons or bare metal stents).

Paclitaxel-coated balloons and paclitaxel-eluting stents are approved to treat obstructed lesions in arteries of the legs. The authors of the paper analysed data from previously conducted randomised-controlled trials.

The letter recommends doctors continue to monitor patients who have been treated with these devices and discuss the benefits and risks of all available treatment options for patients with peripheral arterial disease. At this time, the FDA believes that the benefits continue to outweigh the risks for approved paclitaxel-coated balloons and paclitaxel-eluting stents when used as indicated.

Read FDA Letter to Health Care Providers