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

Benjamin L Zhang; Richard W Bianco; Frederick J Schoen

doi:10.3389/fcvm.2019.00072

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

Front Cardiovasc Med. 2019 Jun 7:6:72. doi: 10.3389/fcvm.2019.00072. eCollection 2019.

Authors

Benjamin L Zhang¹, Richard W Bianco¹, Frederick J Schoen²

Affiliations

¹ Department of Surgery, University of Minnesota, Minneapolis, MN, United States.
² Department of Pathology, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, United States.

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.

Keywords: animal models; heart valve substitutes; preclinical studies; regulatory pathway; tissue engineered heart valves; translation.

Publication types

Review