FDA issues warning on PAD vascular balloon, stent

By AuntMinnie.com staff writers

January 18, 2019 -- The U.S. Food and Drug Administration (FDA) has issued a warning to healthcare professionals about the use of certain drug-containing balloons and stents in patients with peripheral arterial disease (PAD).

The agency is alerting them to a possible increased risk of death at two years and beyond in patients with PAD who are treated with vascular balloons coated with the drug paclitaxel or stents that release paclitaxel in the femoropopliteal artery in the leg.

The warning was prompted by a study published December 6, 2018, in the Journal of the American Heart Association (Katsanos et al).

The FDA is urging doctors to monitor patients treated with these devices, and it encourages them to report adverse events through its MedWatch system.

Copyright © 2019 AuntMinnie.com

To read this and get access to all of the exclusive content on AuntMinnie.com create a free account or sign-in now.

Member Sign In:
MemberID or Email Address:  
Do you have a AuntMinnie.com password?
No, I want a free membership.
Yes, I have a password:  
Forgot your password?
Sign in using your social networking account:
Sign in using your social networking