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

Frontiers in Cardiovascular Medicine

article

Benjamin L. Zhang¹  Richard W. Bianco¹  Frederick J. Schoen² 

[1] Department of Surgery, University of Minnesota;Department of Pathology, Brigham and Women's Hospital and Harvard Medical School

关键词: heart valve substitutes;    tissue engineered heart valves;    regulatory pathway;    translation;    preclinical studies;    animal models;   

DOI  :  10.3389/fcvm.2019.00072

学科分类：地球科学(综合)

来源: Frontiers

【 摘 要 】

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.

【 授权许可】

CC BY