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

doi:10.1007/978-1-59745-004-1_11

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 proceeding › Chapter

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 language	English (US)
Title of host publication	Clinical Evaluation of Medical Devices
Subtitle of host publication	Principles and Case Studies: Second Edition
Publisher	Humana Press
Pages	199-215
Number of pages	17
ISBN (Print)	1588294226, 9781588294227
DOIs	https://doi.org/10.1007/978-1-59745-004-1_11
State	Published - 2006
Externally published	Yes

ASJC Scopus subject areas

General Materials Science
General Chemistry

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1007/978-1-59745-004-1_11

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

Challenges in conducting implantable device trials left ventricular assist devices in destination therapy. / Schmidt-Ott, Ursula Maria; Moskowitz, Alan J.; Gelijns, Annetine C. et al.
Clinical Evaluation of Medical Devices: Principles and Case Studies: Second Edition. Humana Press, 2006. p. 199-215.

Research output: Chapter in Book/Report/Conference proceeding › Chapter

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

Abstract

ASJC Scopus subject areas

UN SDGs

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