Use of Large Animals to Assess Human Safety of Heart Valves and Other Medical Devices

ABSTRACT The use of large animals are critical for the evaluation of safety of human valves and other medical devices. Preclinical assessment includes many factors oriented at maximizing safety and performance. The final step of the device approval for patient's use goes through an exhaustive r...

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Published in:Journal of investigative surgery 2012-02, Vol.25 (1), p.1-2
Main Authors: Bianco, Richard W., Toledo-Pereyra, Luis H.
Format: Article
Language:English
Subjects:
Animals
Device Approval
Equipment Safety
Heart Valve Prosthesis
human heart valves
Humans
Large animals
Models, Animal
other medical devices
safety evaluation
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description ABSTRACT The use of large animals are critical for the evaluation of safety of human valves and other medical devices. Preclinical assessment includes many factors oriented at maximizing safety and performance. The final step of the device approval for patient's use goes through an exhaustive regulatory process to prevent clinical complications or any other close or distant injuries. The development of reproducible animal models, the better understanding of the implantation of medical devices and the follow through with specific clinical trials will complete the significant steps required for the evaluation of safety of human heart valves and other medical devices.
doi_str_mv 10.3109/08941939.2011.648863
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identifier ISSN: 0894-1939
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source Taylor and Francis:Jisc Collections:Taylor and Francis Read and Publish Agreement 2024-2025:Medical Collection (Reading list)
subjects Animals
Device Approval
Equipment Safety
Heart Valve Prosthesis
human heart valves
Humans
Large animals
Models, Animal
other medical devices
safety evaluation
title Use of Large Animals to Assess Human Safety of Heart Valves and Other Medical Devices
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