ASTM F2081-06
(Guide)Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents
Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents
SIGNIFICANCE AND USE
Vascular stents are intended for permanent implant in the human vasculature (native or graft) for the purposes of maintaining vessel patency. The dimensional attributes of vascular stents are critical parameters that aid clinicians in the selection of devices for individual patients. This guide contains a listing of those dimensional attributes that are directly related to the clinical utility and performance of these devices, along with recommendations for consistent methods of measuring these attributes and presenting the information for use in clinical decision making. This guide can be used by the manufacturers and researchers of stents to provide consistency of measurement and labeling of these dimensional characteristics. It may have use in the regulation of these devices by appropriate authorities.
The dimensional attributes included in this guide are those that are deemed related to or possibly predictive of successful clinical performance of the stent, based on prior clinical experience; however, because of the myriad patient and medical factors that influence the clinical outcome of any individual treatment, conformance of a stent and delivery system with the recommendations in this guide should not be interpreted as a guarantee of clinical success in any individual patient or group of patients.
SCOPE
1.1 This guide covers the identification of and recommended measurement methods for those dimensional attributes of vascular stents that are deemed relevant to successful clinical performance. The delivery system packaged with and labeled specifically for use during the placement of the stent is also included within the scope of this guide.
1.2 This guide addresses only the dimensional characteristics of stents. Material property and stent functional characteristics are not addressed herein. All dimensional characteristics described in this guide refer to in vitro ("bench-top") characterization. Because of variable patient factors, for example, vessel compliance, the actual in vivo characteristics may be slightly different.
1.3 This guide includes recommendations generally applicable to balloon-expandable and self-expanding stents fabricated from metals and metal alloys. It does not specifically address any attributes unique to coated stents or polymeric or biodegradable stents, although the application of this guide to those products is not precluded.
1.4 While they are not specifically included within the scope of this guide, stents indicated for placement in nonvascular locations, such as the esophagus or bile duct, also might be characterized by the methods contained herein. Likewise, this guide does not include recommendations for endovascular grafts ("stent-grafts") or other conduit devices commonly used to treat aneurysmal disease or peripheral vessel trauma or to provide vascular access, although some information included herein may be applicable to those devices.
1.5 This guide does not include recommendations for balloon catheters sold as stand-alone angioplasty catheters, even though some of those catheters may be used for the delivery of unmounted stents supplied without a delivery system. Requirements for angioplasty catheters are contained in standards ISO 10555-1 and ISO 10555-4.
1.6 The units of measurements used throughout this guide reflect the hybrid system in common clinical use in the United States as of the time of the original approval of this guide. Since a primary purpose of this guide is to promote uniformity of labeling to facilitate the selection of devices by clinical users, the units most preferred by users were selected for this guide. Where those units are not SI units, or derivatives thereof, SI units are provided in parentheses.
General Information
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Standards Content (Sample)
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Designation: F2081 − 06
StandardGuide for
Characterization and Presentation of the Dimensional
1
Attributes of Vascular Stents
This standard is issued under the fixed designation F2081; 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 1.6 The units of measurements used throughout this guide
reflect the hybrid system in common clinical use in the United
1.1 This guide covers the identification of and recom-
States as of the time of the original approval of this guide.
mended measurement methods for those dimensional attributes
Since a primary purpose of this guide is to promote uniformity
of vascular stents that are deemed relevant to successful
of labeling to facilitate the selection of devices by clinical
clinical performance. The delivery system packaged with and
users, the units most preferred by users were selected for this
labeled specifically for use during the placement of the stent is
guide. Where those units are not SI units, or derivatives
also included within the scope of this guide.
thereof, SI units are provided in parentheses.
1.2 This guide addresses only the dimensional characteris-
tics of stents. Material property and stent functional character- 2. Referenced Documents
istics are not addressed herein. All dimensional characteristics
2.1 ISO Standards:
described in this guide refer to in vitro (“bench-top”) charac-
ISO 10555-1, Sterile, Single-Use Intravascular Catheters,
terization. Because of variable patient factors, for example,
2
General Requirements
vessel compliance, the actual in vivo characteristics may be
ISO 10555-4, Sterile, Single-Use Intravascular Catheters—
slightly different.
2
Balloon Dilation Catheters
1.3 This guide includes recommendations generally appli-
3. Terminology
cable to balloon-expandable and self-expanding stents fabri-
cated from metals and metal alloys. It does not specifically
3.1 Definitions of Terms Specific to This Standard:
address any attributes unique to coated stents or polymeric or
3.1.1 balloon-expandable stent, n—a stent that is expanded
biodegradable stents, although the application of this guide to
at the treatment site by a balloon catheter. The stent is altered
those products is not precluded.
permanently by the balloon expansion such that the stent
remains expanded after deflation of the balloon.
1.4 Whiletheyarenotspecificallyincludedwithinthescope
of this guide, stents indicated for placement in nonvascular
3.1.2 bridge, n—a connecting element between the radial
locations, such as the esophagus or bile duct, also might be
support aspects of a stent. A bridge may have unique design
characterized by the methods contained herein. Likewise, this
features, as compared to a strut, to enhance longitudinal
guide does not include recommendations for endovascular
flexibility and minimize shortening.
grafts (“stent-grafts”) or other conduit devices commonly used
3.1.3 crimp, v—tosecurethestentonthedeliverysystemby
to treat aneurysmal disease or peripheral vessel trauma or to
compressing the stent onto the balloon. Stents sold unmounted
provide vascular access, although some information included
must be crimped manually by the clinical staff before use.
herein may be applicable to those devices.
3.1.4 crossing profile, n—a linear measure of the maximum
1.5 This guide does not include recommendations for bal-
breadth of the stent/delivery system over the distal-most region
loon catheters sold as stand-alone angioplasty catheters, even
of the delivery system.
though some of those catheters may be used for the delivery of
3.1.5 delivery system, n—asystemthatisusedtodeliverand
unmounted stents supplied without a delivery system. Require-
deploy a stent at the target site. A delivery system may be
ments for angioplasty catheters are contained in standards ISO
similar to a balloon dilatation catheter; a delivery system for a
10555-1 and ISO 10555-4.
self-expanding stent might not have a balloon.
3.1.6 diameter, n—refers to the inside diameter (ID) of the
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and
stent unless otherwise noted.
Surgical Materials and Devicesand is the direct responsibility of Subcommittee
F04.30 on Cardiovascular Devices.
Current edition approved Sept. 1, 2006. Published September 2006. Originally
2
approved in 2001. Last previous edition approved in 2001 as F2081 – 01. DOI: Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
10.1520/F2081-06. 4th Floor, New York, NY 10036, http://www.ansi.org.
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