Preclinical Assessment of Cardiac Valve Substitutes: Current Status and Considerations for Engineered Tissue Heart Valves

Benjamin L. Zhang, Richard W. Bianco, Frederick J. Schoen

Research output: Contribution to journalReview articlepeer-review

7 Scopus citations

Abstract

Tissue engineered heart valve (TEHV) technology may overcome deficiencies of existing available heart valve substitutes. The pathway by which TEHVs will undergo development and regulatory approval has several challenges. In this communication, we review: (1) the regulatory framework for regulation of medical devices in general and substitute heart valves in particular; (2) the special challenges of preclinical testing using animal models for TEHV, emphasizing the International Standards Organization (ISO) guidelines in document 5840; and (3) considerations that suggest a translational roadmap to move TEHV forward from pre-clinical to clinical studies and clinical implementation.

Original languageEnglish (US)
Article number72
JournalFrontiers in Cardiovascular Medicine
Volume6
DOIs
StatePublished - Jun 7 2019

Bibliographical note

Publisher Copyright:
© Copyright © 2019 Zhang, Bianco and Schoen.

Keywords

  • animal models
  • heart valve substitutes
  • preclinical studies
  • regulatory pathway
  • tissue engineered heart valves
  • translation

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