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

Publication ,  Journal Article
Shah, BR; Schulman, KA
Published in: Dialogues in Cardiovascular Medicine
December 1, 2008

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

Published In

Dialogues in Cardiovascular Medicine

ISSN

1272-9949

Publication Date

December 1, 2008

Volume

13

Issue

4

Start / End Page

267 / 272

Related Subject Headings

  • Cardiovascular System & Hematology
 

Citation

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MLA
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Shah, B. R., & Schulman, K. A. (2008). What are the regulatory and economic challenges posed by drug-eluting stents? Dialogues in Cardiovascular Medicine, 13(4), 267–272.
Shah, B. R., and K. A. Schulman. “What are the regulatory and economic challenges posed by drug-eluting stents?Dialogues in Cardiovascular Medicine 13, no. 4 (December 1, 2008): 267–72.
Shah BR, Schulman KA. What are the regulatory and economic challenges posed by drug-eluting stents? Dialogues in Cardiovascular Medicine. 2008 Dec 1;13(4):267–72.
Shah, B. R., and K. A. Schulman. “What are the regulatory and economic challenges posed by drug-eluting stents?Dialogues in Cardiovascular Medicine, vol. 13, no. 4, Dec. 2008, pp. 267–72.
Shah BR, Schulman KA. What are the regulatory and economic challenges posed by drug-eluting stents? Dialogues in Cardiovascular Medicine. 2008 Dec 1;13(4):267–272.

Published In

Dialogues in Cardiovascular Medicine

ISSN

1272-9949

Publication Date

December 1, 2008

Volume

13

Issue

4

Start / End Page

267 / 272

Related Subject Headings

  • Cardiovascular System & Hematology