Paclitaxel-Coated PAD Devices Under US FDA Scrutiny

18 Jan 2019

• By David Filmore

The agency sent a letter to health-care providers stating that it is investigating reports of an elevated risk of death for patients starting two years after treatment with paclitaxel-coated balloons or paclitaxel-eluting stents. But FDA is not taking any regulatory action at this point.

Cholesterol plaque in artery — • Source: Shutterstock

US FDA is investigating the possible increased risk of death from use of paclitaxel-coated balloons and stents to treat peripheral artery disease (PAD), but the agency says benefits continue to outweigh the risks of approved devices.

FDA disclosed its ongoing analysis of the issue in a Jan. 17 letter to health-care providers. It cites a...