Provides consensus guidelines from the European Bifurcation Club for bench testing of stents in coronary bifurcations where FDA/ISO guidelines are limited.
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Guides standardized bench testing of bifurcation stents in practice; extends limited FDA/ISO standards for device evaluation.
This is a consensus document from the European Bifurcation Club concerning bench testing in coronary artery bifurcations. It is intended to provide guidelines for bench assessment of stents and other strategies in coronary bifurcation treatment where the United States Food and Drug Administration (FDA) or International Organization for Standardization (ISO) guidelines are limited or absent. These recommendations provide guidelines rather than a step-by-step manual. We provide data on the anatomy of bifurcations and elastic response of coronary arteries to aid model construction. We discuss testing apparatus, bench testing endpoints and bifurcation nomenclature.
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Ormiston et al. (2018) conducted a review in Coronary artery bifurcations. Bench testing guidelines was evaluated. The European Bifurcation Club provides consensus guidelines for bench assessment of stents and other strategies in coronary bifurcation treatment where FDA or ISO guidelines are limited.
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