Drug eluting stents and the critical path initiative: Evolving paradigms for safety evaluation.


Journal Article

Recent discussions between FDA and other stakeholders have focused on the benefits and risks associated with drug eluting stents (DES). A particular topic of focus is DES thrombosis, a rare, but serious, clinical event that may occur months to years after the initial implantation. FDA continues vigilant postmarket surveillance of DES currently on the market and is working with stent manufactures to ensure that new DES platforms in the development pipeline are safe and effective. FDA is also taking steps, under its Critical Path Initiative (CPI) [FDA. Innovation or Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products, March 2004.http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.html], to help address current and future DES safety issues. This article describes some of these activities.:

Full Text

Duke Authors

Cited Authors

  • Sanhai, WR; Stockbridge, N; Fiorentino, RP; Uchida, T; Uhl, K; Krucoff, MW

Published Date

  • 2007

Published In

Volume / Issue

  • 4 / 2

Start / End Page

  • 43 - 46

PubMed ID

  • 24980839

Pubmed Central ID

  • 24980839

International Standard Serial Number (ISSN)

  • 1740-6749

Digital Object Identifier (DOI)

  • 10.1016/j.ddtec.2007.10.004


  • eng

Conference Location

  • England