ASTM F2743-11
(Guide)Standard Guide for Coating Inspection and Acute Particulate Characterization of Coated Drug-Eluting Vascular Stent Systems
Standard Guide for Coating Inspection and Acute Particulate Characterization of Coated Drug-Eluting Vascular Stent Systems
SIGNIFICANCE AND USE
The shedding of the coating from a vascular stent can alter its clinical safety and/or therapeutic benefit. Clinical performance (for example, drug elution) may be affected by particulate generation from the coated stent system and coating defects. This document provides guidance for coating inspection and acute particulate characterization of drug eluting vascular stents. Information about the potential for shedding can be gained during bench testing. The general guidelines presented here may be used for writing detailed protocols for specific products at the various stages of the product development process. Such testing may be performed during device development, design validation testing, lot-release testing, and/or stability testing although different requirements may apply at each stage. These suggested methods may represent a reasonable simulation of clinical usage. When establishing the coating inspection and acute particulate characterization testing conditions, the current clinical usage/practice (for example, post-dilation, overlapping stents) and the instructions for use (IFU), as applicable, should be considered. While methods for chronic particulate characterization and coating inspection have not been established, these suggested methods may be helpful in the development of chronic methods. Testing in accordance with recommendations in this guide will generate data that may lead to further improvements in the method and its validation, as well as possible advancements in device design and performance. See also FDA Guidance for Industry and FDA Staff and AAMI TIR42:2010.
SCOPE
1.1 This guide describes recommended in vitro test procedures for coating inspection and acute particulate characterization of coated drug-eluting vascular (balloon-expandable and self-expanding) stent systems.
1.2 Recommended practices for coating inspection and acute particulate characterization include baseline (deployment) testing and simulated use testing. This guide describes the capture and analysis of particulates. This guide describes the inspection of the coated stent surface. This guide was developed for characterization and not intended for production release testing of coated drug-eluting vascular stent systems although some sections may be appropriate.
1.3 Chronic particulate characterization and coating inspection are not included herein.
1.4 Coating systems specifically designed to degrade or otherwise intentionally separate themselves from the permanent stent structure may not be fully addressed herein.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.
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Designation: F2743 − 11
Standard Guide for
Coating Inspection and Acute Particulate Characterization of
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Coated Drug-Eluting Vascular Stent Systems
This standard is issued under the fixed designation F2743; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope vascular Stents and Associated Delivery Systems, April
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18, 2010
1.1 This guide describes recommended in vitro test proce-
AAMITIR42:2010Evaluation of Particulates Associated
dures for coating inspection and acute particulate characteriza-
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with Vascular Medical Devices
tion of coated drug-eluting vascular (balloon-expandable and
self-expanding) stent systems.
3. Terminology
1.2 Recommended practices for coating inspection and 3.1 Definitions:
acute particulate characterization include baseline (deploy- 3.1.1 mock vessel—physicalsimulationofthevasculatureat
ment) testing and simulated use testing. This guide describes the intended clinical deployment site.
the capture and analysis of particulates. This guide describes
3.1.2 stent system—a system comprised of a vascular stent
the inspection of the coated stent surface. This guide was
and its delivery system.
developed for characterization and not intended for production
3.1.3 tracking—navigation of a guide wire, guide catheter,
release testing of coated drug-eluting vascular stent systems
and/or stent system through either actual or simulated vascular
although some sections may be appropriate.
anatomy.
1.3 Chronic particulate characterization and coating inspec-
3.1.4 tracking fixture—a model that simulates or replicates
tion are not included herein.
thegeometryofarepresentativevasculaturethroughwhichthe
stent system will be passed.
1.4 Coating systems specifically designed to degrade or
otherwise intentionally separate themselves from the perma-
3.2 Definitions of Terms Specific to This Standard:
nent stent structure may not be fully addressed herein.
3.2.1 acute—a test timeframe intended to include stent
delivery and deployment beginning with the initial insertion of
1.5 The values stated in SI units are to be regarded as
stent system until full removal of the delivery system and its
standard. No other units of measurement are included in this
accessory devices.
standard.
3.2.2 baseline—coating inspection and acute particulate
1.6 The values stated in inch-pound units are to be regarded
characterizationafterstentexpansiontothedesireddiameterin
as standard. The values given in parentheses are mathematical
an unconstrained environment and without tracking.
conversions to SI units that are provided for information only
3.2.3 chronic—a test timeframe intended to mimic the
and are not considered standard.
implantation time after full removal of the delivery system and
its accessory devices.
2. Referenced Documents
3.2.4 constrained environment—a deployment site in which
2.1 Other Standards:
the stent is deployed into a mock vessel.
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USP <788> Particulate Matter in Injections
3.2.5 simulated use—coating inspection and acute particu-
FDA Guidance for Industry and FDA StaffNon-Clinical
late characterization after tracking in simulated anatomy and
Engineering Tests and Recommended Labeling for Intra-
aqueous environment. It may also include deployment in bent
configuration, deployment in overlapped configuration, post-
dilatation,orotherscenariosthatcanreasonablybeexpectedin
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This guide is under the jurisdiction of ASTM Committee F04 on Medical and clinical use.
Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.30 on Cardiovascular Standards.
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Current edition approved Oct. 1, 2011. Published November 2011. DOI: Available from Food and DrugAdministration (FDA), 10903 New Hampshire
10.1520/F2743-11. Ave., Silver Spring, MD 20993-0002, http://www.fda.gov.
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Available from U.S. Pharmacopeia (USP), 12601Twinbrook Pkwy., Rockville, Available from Association for the Advancement of Medical Instrumentation
MD 20852-1790, http://www.usp.org. (AAMI), 4301 North Fairfax Dr., Suite 301, Arlington, VA 22203-1633.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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F2743 − 11
3.2.6 unconstrained environment—a deployment site in 5. Significance and Use
which the stent is not constrained by a mock vessel. Compare
5.1 The shedding of the coating from a vascular stent can
to “Constrained Environment”.
alter its clinical safety and/or therapeutic benefit. Clinical
performance (for example, drug elution) may be affected by
4. Summary of Practice
particulategenera
...
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