FDA Update: Treatment of PAD With Paclitaxel-Coated Balloons and Paclitaxel-Eluting Stents
Earlier this year, the U.S. Food and Drug Administration (FDA) notified health care providers about a potential late mortality signal in patients treated for peripheral artery disease (PAD) in the femoropopliteal artery with paclitaxel-coated balloons and paclitaxel-eluting stents. In June, an FDA panel met to discuss the notifications concluding that a late mortality signal associated with the use of paclitaxel-coated devices to treat femoropopliteal PAD was present, and that additional clinical study data are needed to fully evaluate the late mortality signal. The FDA has issued additional recommendations for health care providers and patients. Read more.