COURSE TOPICS

Learning and following this standard, developers can perform a complete and correct assessment of the product’s physical, mechanical, chemical, and biological properties of transcatheter cardiac occluders and of their materials and components. Recommended in-vivo animal evaluations are also provided, including choice of animal model; study duration; device size; sample size; applicability and relevance based on similarities or differences between animal model and humans for devise use; and also, alternative implantation site or techniques.

Extensive guidelines are provided to design and conduct clinical trials, including imaging assessment, target population and follow-up duration and methods, as well as objective criteria for establishing safety, usability and clinical benefits.