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FDA Issues Letter Regarding Safety Concerns With Paclitaxel-Coated Devices

Gina Columbus @ginacolumbusonc
Published: Thursday, Jan 17, 2019

The FDA has issued a letter to healthcare providers that they should monitor patients with a type of peripheral arterial disease (PAD) who have been treated with vascular balloons that were coated with paclitaxel or stents that release paclitaxel in the femoropopliteal artery in the leg.1

The study investigators concluded in the article that further investigations are warranted.


  1. Treatment of Peripheral Arterial Disease with Paclitaxel-Coated Balloons and Paclitaxel-Eluting Stents Potentially Associated with Increased Mortality - Letter to Health Care Providers. FDA. Published January 17, 2019." . Accessed January 17, 2019.
  2. Katsanos K, Spiliopoulos S, Kitrou P, Krokidis M, Karnabatidis D. Risk of death following application of paclitaxel-coated balloons and stents in the femoropopliteal artery of the leg: a systematic review and meta-analysis of randomized controlled trials. JAHA. 2018;7:e011245. doi: 10.1161/JAHA.118.011245.

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