Panelists Grapple With Unclear Data At Paclitaxel Meeting

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.

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...