title: 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 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.
authors.affiliation: Department of Surgery, Surgical Research Laboratories, University of Minnesota, Minneapolis, Minnesota 55455, USA. bianco001@umn.edu
authors.forename: Richard W
authors.initials: RW
authors.lastname: Bianco
authors.forename: Luis H
authors.initials: LH
authors.lastname: Toledo-Pereyra
mesh_terms: D000818:Animals; D018795:Device Approval; D004869:Equipment Safety; D006350:Heart Valve Prosthesis; D006801:Humans; D023421:Models, Animal