• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

Drug Delivery Business

  • Clinical Trials
  • Research & Development
  • Drug-Device Combinations
  • FDA
  • Pharmaceuticals
  • Policy

FDA updates docs on review of paclitaxel devices for PAD

March 18, 2019 By Sarah Faulkner

FDA-logo-newThe FDA said last week that its preliminary review of long-term follow-up data found a “potentially concerning signal” of increased long-term mortality in people with peripheral artery disease who were treated with paclitaxel-coated devices compared to those treated with bare devices.

In a letter to healthcare providers, the U.S. regulatory agency reported that there was a 50% increased risk of mortality in people treated with paclitaxel-coated devices versus those treated with control devices in the three trials with five-year follow-up data.

Importantly, the FDA urged doctors to interpret these data with caution.

“First, there is large variability in the risk estimate of mortality due to the limited amount of long-term data. Second, these studies were not originally designed to be pooled, introducing greater uncertainty in the results. Third, the specific cause and mechanism of the increased mortality is unknown,” the agency wrote.

The FDA said that doctors should seek alternative treatment options for patients while the agency assesses the long-term mortality signal linked to paclitaxel devices.

“The FDA intends to conduct additional analyses to determine whether the benefits continue to outweigh the risks for approved paclitaxel-coated balloons and paclitaxel-eluting stents when used in accordance with their indications for use,” the FDA wrote. “The FDA will also evaluate whether these analyses impact the safety of patients treated with these devices for other indications, such as treatment of arteriovenous access stenosis or critical limb ischemia.”

The FDA plans to convene an advisory committee meeting of the Circulatory System Devices Panel to hold a discussion on the long-term mortality signal. The timing of the adcomm meeting has not yet been announced.

The FDA’s latest moves come in response to a meta-analysis that was published last year in the Journal of the American Heart Association. The study suggested that paclitaxel devices were linked to a heightened mortality rate in people with PAD who were treated with paclitaxel-coated and paclitaxel-eluting devices compared to bare devices.

Want to stay on top of DDBN content? Sign up for our e-mail newsletter for a weekly dose of drug-device news.

Filed Under: Cardiovascular, Drug-Device Combinations, Featured, Pharmaceuticals, Regulatory/Compliance, Vascular Tagged With: FDA

IN CASE YOU MISSED IT

  • BD stock up on Street-beating preliminary quarterly revenue numbers
  • Locate Bio lands FDA breakthrough nod for bone infection device
  • PerkinElmer to acquire Oxford Immunotec
  • Evonik buys polymers business from Durect Corp.
  • New Croatian notified body designated to European MDR

Primary Sidebar

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Need Drug Delivery Business News in a minute? We Deliver!
Drug Delivery Enewsletters get you caught up on all the mission critical news you need in med tech. Sign up today.

Tweets by DrugDeliveryNow

Footer

MassDevice Medical NETWORK

MassDevice
DeviceTalks
Medical Design & Outsourcing
Medical Tubing + Extrusion

DRUG DELIVERY BUSINESS NEWS

Subscribe to Drug Delivery News
Advertise with us
About
Contact us
Privacy
Add us on FacebookFollow us on TwitterConnect with us on LinkedIn

Copyright © 2021 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Advertise | Privacy Policy | RSS