Large animal models for the interventional cardiologist: a comparative anatomy, imaging, histopathology and regulatory perspective

Summary

Preclinical research plays a pivotal role in the medical device development process. Devices have to be tested in an anatomic environment that is as representative as possible of human anatomy. Studies conducted in large animals provide essential information about product design and performance and are invaluable in helping to ensure that human clinical trials can be performed safely and accepted by regulatory bodies worldwide.

This stage can include different phases: research and development (R&D) studies, regulatory studies with the paramount step of histopathologic assessment and finally the training of the end-users before performing the first-in-human (FIH) implantation or intervention. Robust knowledge of biology as well as of comparative anatomy and physiology is an essential aspect of large animal preclinical research.

Achieving a reliable pathologic model in large animals is challenging but can provide insightful information. In the present article, we share our know-how about some of the models commonly used in cardiovascular research. In summary, large animal research is invaluable in the advancement of medical technology and must be performed in scientifically, technically and ethically acceptable environments. Preclinical studies of medical devices must therefore be performed in state-of-the-art laboratories with highly trained professionals.

Rationale for animal studies

Preclinical...