1. Scope
1.1 This guide describes recommended in-vitro test procedures for assessing the acute coating durability of polymer-coated drug-eluting vascular stents. Both balloon-expanding and self-expanding stents are included within the scope.
1.2 Recommended practices for assessing acute coating durability include the simulated clinical tracking and deployment, capture and analysis of any particulate released, and pre-and post-deployment inspection of the stent surface. Analysis of particulates and surface inspection can be accomplished using the same test articles subjected to clinical tracking and deployment.
1.3 Acute coating durability is defined herein as relating to the period of time from the insertion of the stent delivery system into the body until the full removal of that delivery system and its accessory devices. During the acute phase, the stent system is tracked through the vascular system to the target site, the stent is deployed, the delivery system is withdrawn, and (optionally) the stent is post-dilated. The assessment of chronic coating durability, that is, the durability after some extended period of simulated in-vivo loading, is not included herein.
1.4 Bioresorbable polymer coatings or other coating designs specifically designed to ablate or otherwise intentionally separate themselves from the stent structure are not addressed herein.
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
Keywords
stent coating; durability; particulate
The title and scope are in draft form and are under development within this ASTM Committee.
Citing ASTM Standards
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