FDA Releases 3rd Update Letter to Providers Regarding Use of Paclitaxel in Peripheral Arterial Disease

August 7, 2019 — The United States Food and Drug Administration (U.S. FDA) today released an update to its discussion on paclitaxel and possible related signals of mortality in peripheral arterial disease treatment.

The letter can be found online at:

https://www.fda.gov/medical-devices/letters-health-care-providers/august-7-2019-update-treatment-peripheral-arterial-disease-paclitaxel-coated-balloons-and-paclitaxel

The concern about paclitaxel use in peripheral arterial disease was first raised in a publication by Konstantinos Katsanos, MSc, MD, PhD, EBIR, and colleagues, in a December 2018 meta-analysis¹ that found patients receiving treatment with paclitaxel devices in the femoropopliteal arteries experienced higher late mortality. An FDA Advisory Committee Meeting was held June 19-20, 2019 to discuss the data in depth. This letter is the first official communication from the FDA following the Committee Meeting.

More information and commentary regarding paclitaxel use in PAD can be found in the June issue of Vascular Disease Management, including an interview with Dr. Katsanos:

The Future is Going to Be Drug-Coated or Drug-Eluting. We Need Individual Patient Data to Move Forward.

Vascular Disease Management talks with Konstantinos Katsanos, MSc, MD, PhD, EBIR, Assistant Professor, Interventional Radiology, School of Medicine, Patras University Hospital, Patras, Greece.

Reference

1. Katsanos K, Spiliopoulos S, Kitrou P, Krokidis M, Karnabatidis D. Risk of death following application of paclitaxel-coated balloons and stents in the femoropopliteal artery of the leg: a systematic review and meta-analysis of randomized controlled trials. J Am Heart Assoc. 2018 Dec 18; 7(24): e011245.