October 1, 2008Open Access
View Full PaperDrug-Eluting Stents in Preclinical Studies
Key Result
This expert consensus document provides an updated, integrated view for testing novel drug-eluting technologies in preclinical models, consistent with recent FDA draft guidance.
Structured PICO
P
Population
Preclinical models for testing drug-eluting technologies
I
Intervention
Standardized preclinical testing methods for novel drug-eluting technologies (including bioabsorbable coatings, totally bioabsorbable stents, bifurcation stents, and stent-free balloon-based drug delivery)
This expert consensus document provides updated guidelines for the preclinical evaluation of novel drug-eluting stent technologies, consistent with recent FDA guidance.
Abstract
Coronary drug-eluting stents are commonplace in clinical practice with acceptable safety and efficacy. Preclinical evaluation of novel drug-eluting stent technologies has great importance for understanding safety and possibly efficacy of these technologies, and well-defined preclinical testing methods clearly benefit multiple communities within the developmental, testing, and clinical evaluation chain. An earlier consensus publication enjoyed widespread adoption but is in need of updating. This publication is an update, presenting an integrated view for testing drug-eluting technologies in preclinical models, including novel devices such as bioabsorbable coatings, totally bioabsorbable stents, bifurcation stents, and stent-free balloon-based drug delivery. This consensus document was produced by preclinical and translational scientists and investigators engaged in interventional technology community. The United States Food and Drug Administration (USFDA) recently issued a Draft Guidance for Industry Document for Drug-Eluting Stents. This expert consensus document is consistent with the Food and Drug Administration guidance. The dynamic nature of this field mandates future modifications and additions that will be added over time.