Paclitaxel-Device Firestorm in PAD

21 August 2019
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Earlier this year, the FDA notified health care providers about a late mortality signal in patients treated for peripheral artery disease (PAD) in the femoropopliteal artery with paclitaxel-coated balloons and paclitaxel-eluting stents.

On August 7th 2019, the FDA issued an update to provide the latest information on their analysis of long-term follow-up data from premarket trials and to provide summary information from their June 2019 advisory panel meeting. In addition, they include recommendations to health care providers for assessing and treating patients with PAD using paclitaxel-coated devices.

The full update can be consulted on the FDA website: https://www.fda.gov/medical-devices/letters-health-care-providers/august-7-2019-update-treatment-peripheral-arterial-disease-paclitaxel-coated-balloons-and-paclitaxel