FDA Tells Providers To Limit Use Of Paclitaxel-Coated Stents

New US FDA analysis of paclitaxel-coated devices to treat peripheral arterial disease matches previous reports of an increased death risk tied to use of the devices. The agency is encouraging providers to look to other treatment options while analysis continues.

Stent angioplasty.3d illustration
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US FDA is urging providers to consider alternatives to paclitaxel-coated devices for the treatment of peripheral arterial disease (PAD) after an agency analysis found the drug-eluting stents and balloons were linked to a higher patient mortality rate.

FDA initially issued an alert about the possible long-term mortality risk in January, after a meta-analysis of randomized trials published in the Journal of the American Heart Association detected the...

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