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Panelists Grapple With Unclear Data At Paclitaxel Meeting

 
• By Elizabeth Orr

A two-day US FDA advisory committee meeting this week yielded plenty of discussion about the apparent mortality risk tied to paclitaxel-coated balloons and stents, but few definitive conclusions.

FDA Advisory Committee Feature image

More research and stakeholder cooperation are needed to investigate an apparent mortality risk tied to the use of paclitaxel-coated balloons and stents to treat peripheral arterial disease (PAD), the US Food and Drug Administration’s Circulatory Devices Advisory Panel says.

The call for additional investigation was the strongest conclusion of a two-day panel meeting on the devices, held on 19 and 20 June. The meeting was called to further discuss the safety and regulation of the devices, a subject of interest to the FDA since a meta-analysis of randomized trials published in the Journal of the American Heart Association in December 2018 detected an increased long-term mortality risk for PAD patients who received devices coated with the drug

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