Use of large animals to assess human safety of heart valves and other medical devices

Richard W. Bianco, Luis H. Toledo-Pereyra

Research output: Contribution to journalReview articlepeer-review

1 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)1-2
Number of pages2
JournalJournal of Investigative Surgery
Volume25
Issue number1
DOIs
StatePublished - Feb 1 2012

Keywords

  • Human heart valves
  • Large animals
  • Other medical devices
  • Safety evaluation

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