What are the regulatory and economic challenges posed by drug-eluting stents?

Medical devices are complex therapeutics that pose unique regulatory, ethical, legal, and financial challenges. Drug-eluting stents were heralded initially as a breakthrough in the treatment of coronary artery disease. However, later revelations about the safety and efficacy of drug-eluting stents would highlight challenges in the regulatory approval of medical devices. In this paper, we discuss a few key issues that arose from debates about drug-eluting stents: Are trials for medical devices adequately designed to examine long-term safety? What are the ethics of phase 1 research for medical devices when long-term complications are unknown? What are the intellectual property rights issues for medical technology? How do payment systems create incentives that encourage overuse of medical devices? Copyright © 2008 LLS SAS. All rights reserved.

Duke Scholars

Author Bimal Ramesh Shah Medicine, Cardiology