This consensus document outlines integrated requirements for evaluating drug-eluting stents in preclinical models, encompassing study design, experimental performance, and histopathologic evaluations.
This consensus document provides standardized requirements for the preclinical evaluation of drug-eluting stents to better predict clinical safety and efficacy.
T he arrival of drug-eluting stents raises important ques- tions about preclinical evaluation of devices and the optimal means of predicting clinical safety and efficacy.The Interventional, Regulatory, Commercial, and Scientific communities have all asked for assistance in defining criteria for device evaluation.This document is an integrated view of requirements for evaluating drug-eluting stents in preclinical models.The suggested requirements encompass study design, experimental performance, and histopathologic evaluations, emphasizing safety and efficacy at multiple points in time.This is a consensus document assembled by clinical, academic, and industrial investigators engaged in preclinical interventional device evaluation.Suggested requirements might well serve as a standard but do not prescribe a single manner in which all devices should be evaluated.They instead motivate such an evaluation and describe how examinations might be performed.It is understood that methods will change and knowledge will evolve, in particular as corroboration is established with clinical data.The dynamic nature of this document allows for future modifications and additions.
Schwartz et al. (2002) conducted a review in Preclinical evaluation of drug-eluting stents. Drug-eluting stents was evaluated. This consensus document outlines integrated requirements for evaluating drug-eluting stents in preclinical models, encompassing study design, experimental performance, and histopathologic evaluations.