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Front. Cardiovasc. Med. | doi: 10.3389/fcvm.2019.00072

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

 Frederick J. Schoen1*,  Ben Zhang2 and Richard W. Bianco2
  • 1Brigham and Women's Hospital, Harvard Medical School, United States
  • 2Medical School, University of Minnesota, United States

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 form pre-clinical to clinical studies and clinical implementation.

Keywords: Heart valve substitutes, Tissue engineered heart valves, regulatory pathway, translation, preclinical studies, Animal Models

Received: 10 Jan 2019; Accepted: 13 May 2019.

Edited by:

Carlijn V. Bouten, Eindhoven University of Technology, Netherlands

Reviewed by:

Giovanni Biglino, University of Bristol, United Kingdom
Zeeshan Syedain, University of Minnesota Twin Cities, United States  

Copyright: © 2019 Schoen, Zhang and Bianco. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

* Correspondence: Prof. Frederick J. Schoen, Brigham and Women's Hospital, Harvard Medical School, Boston, United States,