FDA Update - Treatment of Peripheral Arterial Disease with Paclitaxel-Coated Balloons and Paclitaxel-Eluting Stents Potentially Associated with Increased Mortality

Published: 08/07/2019

  • Food and Drug Administration
Relevant To:
  • All Healthcare Organizations

Earlier this year, the U.S. Food and Drug Administration (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. The FDA is now issued an update to provide the latest information on thier analysis of long-term follow-up data from premarket trials and to provide summary information from our June 2019 advisory panel meeting. In addition, F

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