Challenges in conducting implantable device trials left ventricular assist devices in destination therapy

Ursula Maria Schmidt-Ott, Alan J. Moskowitz, Annetine C. Gelijns, Julie C. Choe, Michael Parides, Deborah V. Davis Ascheim

Research output: Chapter in Book/Report/Conference proceedingChapter

Abstract

The medical device industry is characterized by a high level of innovation and the development of a continuous stream of devices that promise to enhance the life expectancy and quality of life of patients. With changes in US Food and Drug Administration (FDA) regulatory policies and increased demand for more rigorous clinical evidence by payors, physicians, and patients alike, there has been more emphasis on randomized trials to evaluate new devices as they move from bench to bedside.

Original languageEnglish (US)
Title of host publicationClinical Evaluation of Medical Devices
Subtitle of host publicationPrinciples and Case Studies: Second Edition
PublisherHumana Press
Pages199-215
Number of pages17
ISBN (Print)1588294226, 9781588294227
DOIs
StatePublished - Dec 1 2006
Externally publishedYes

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ASJC Scopus subject areas

  • Materials Science(all)
  • Chemistry(all)

Cite this

Schmidt-Ott, U. M., Moskowitz, A. J., Gelijns, A. C., Choe, J. C., Parides, M., & Davis Ascheim, D. V. (2006). Challenges in conducting implantable device trials left ventricular assist devices in destination therapy. In Clinical Evaluation of Medical Devices: Principles and Case Studies: Second Edition (pp. 199-215). Humana Press. https://doi.org/10.1007/978-1-59745-004-1_11