ASTM F3036-13
(Guide)Standard Guide for Testing Absorbable Stents
Standard Guide for Testing Absorbable Stents
SIGNIFICANCE AND USE
4.1 Absorbable cardiovascular stents provide temporary support to the vasculature and are intended to degrade and absorb over time after being implanted into the vasculature.
4.2 The test methods used to evaluate the mechanical performance of absorbable devices are similar to those used to evaluate permanent (non-absorbable) cardiovascular devices. The absorbable-specific pre-test conditioning requirements, handling requirements before and during the test, and time-dependent mechanical property evaluations for absorbable devices are addressed here.
4.3 As the absorbable implant degrades, the mechanical performance of the device also deteriorates. The key to achieving effective revascularization with absorbable devices is to provide an adequate level of luminal support for the time frame needed for vessel stabilization.
SCOPE
1.1 This Guide covers select physical and mechanical characterizations of vascular stents with one or more absorbable components. Such absorbable stents (also referred to as vascular scaffolds) are used to provide temporary luminal support of the coronary and peripheral vasculature following interventional revascularization procedures. This Guide covers devices that are fabricated from one or more degradable polymers and/or metals (from this point on referred to as “absorbable”). This Guide provides a framework for evaluating the change in select physical and mechanical characteristics of absorbable stents from manufacture through their intended degradation in vivo. Specific testing recommendations are limited to existing ASTM standards for stent evaluation.
1.2 Recommendations specific to non-absorbable stents with absorbable coatings are not within scope.
1.3 Recommendations specific to testing absorbable stent grafts are not provided here, however this standard has many elements applicable to testing absorbable stent grafts.
1.4 Clinical need dictates that absorbable stents initially possess the same general dimensions and mechanical function as their non-absorbable counterparts. Thus, utilization of already established mechanical stent evaluation methods is possible when absorbable test specimens are previously conditioned under physiologically relevant temperature and humidity. As a result, this standard addresses absorbable-specific testing issues related to the mechanical and physical evaluation of these devices. This standard is limited to providing absorbable-specific testing recommendations for evaluations where an ASTM method for durable (i.e., non-absorbable) stents is already available. Specifically, this standard provides testing recommendations for adapting the elastic recoil (ASTM F2079), securement/dislodgement (ASTM F2394), and three-point bending (ASTM F2606) tests to fully absorbable devices. This guide generally describes specimen conditioning, as appropriate, for absorbable devices, which can range from none to extensive – depending on the measured attribute and relevant clinical exposure conditions, including time in the in-use environment. There are additional stent evaluation methods that are not addressed explicitly in this guide, e.g., chronic durability, that may require absorbable-specific provisions. The user should justify the appropriate testing for the specific polymer and device.
1.4.1 While the primary purpose of this guide is to address absorbable stent-related issues specific to the tests described in Section 1.3, additional testing (e.g., radial strength) will likely also be needed. Thus, aspects of what is presented herein may be applicable to additional relevant device attributes, such as those described in ISO 25539-1 and/or 25539-2.
1.5 This Guide may not be appropriate for all absorbable devices, for example those that possess limited hydrolytic or corrosion susceptibility and degrade in vivo primarily through enzymatic action. The user is cautioned to consider the appropriateness of the standard in view of ...
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Designation: F3036 − 13
Standard Guide for
1
Testing Absorbable Stents
This standard is issued under the fixed designation F3036; 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 relevant clinical exposure conditions, including time in the
in-use environment. There are additional stent evaluation
1.1 This Guide covers select physical and mechanical char-
methods that are not addressed explicitly in this guide, e.g.,
acterizations of vascular stents with one or more absorbable
chronic durability, that may require absorbable-specific provi-
components. Such absorbable stents (also referred to as vas-
sions. The user should justify the appropriate testing for the
cular scaffolds) are used to provide temporary luminal support
specific polymer and device.
of the coronary and peripheral vasculature following interven-
1.4.1 While the primary purpose of this guide is to address
tional revascularization procedures. This Guide covers devices
absorbable stent-related issues specific to the tests described in
that are fabricated from one or more degradable polymers
Section 1.3, additional testing (e.g., radial strength) will likely
and/or metals (from this point on referred to as “absorbable”).
also be needed. Thus, aspects of what is presented herein may
This Guide provides a framework for evaluating the change in
be applicable to additional relevant device attributes, such as
select physical and mechanical characteristics of absorbable
those described in ISO 25539-1 and/or 25539-2.
stents from manufacture through their intended degradation in
vivo. Specific testing recommendations are limited to existing 1.5 This Guide may not be appropriate for all absorbable
ASTM standards for stent evaluation. devices, for example those that possess limited hydrolytic or
corrosion susceptibility and degrade in vivo primarily through
1.2 Recommendations specific to non-absorbable stents
enzymatic action. The user is cautioned to consider the
with absorbable coatings are not within scope.
appropriateness of the standard in view of the particular
1.3 Recommendations specific to testing absorbable stent
absorbable device and its potential application.
grafts are not provided here, however this standard has many
1.6 This Guide does not address the methods necessary to
elements applicable to testing absorbable stent grafts.
characterize the chemical degradation of the absorbable stent
1.4 Clinical need dictates that absorbable stents initially
(e.g., changes in mass, molecular weight, or degradants).
possess the same general dimensions and mechanical function
However, this type of characterization does represent an
as their non-absorbable counterparts. Thus, utilization of al-
important component of the degradation profile and mecha-
ready established mechanical stent evaluation methods is
nism of the device. These characterizations are addressed in
possible when absorbable test specimens are previously con-
ASTM F1635.
ditioned under physiologically relevant temperature and hu-
1.7 The values stated in SI units are to be regarded as
midity.As a result, this standard addresses absorbable-specific
standard. No other units of measurement are included in this
testing issues related to the mechanical and physical evaluation
standard.
of these devices. This standard is limited to providing
1.8 This standard does not purport to address all of the
absorbable-specific testing recommendations for evaluations
safety concerns, if any, associated with its use. It is the
where an ASTM method for durable (i.e., non-absorbable)
responsibility of the user of this standard to establish appro-
stents is already available. Specifically, this standard provides
priate safety and health practices and determine the applica-
testingrecommendationsforadaptingtheelasticrecoil(ASTM
bility of regulatory limitations prior to use.
F2079), securement/dislodgement (ASTM F2394), and three-
pointbending(ASTMF2606)teststofullyabsorbabledevices.
2. Referenced Documents
This guide generally describes specimen conditioning, as
2
appropriate, for absorbable devices, which can range from 2.1 ASTM Standards:
none to extensive – depending on the measured attribute and D618 Practice for Conditioning Plastics for Testing
E6 Terminology Relating to Methods of Mechanical Testing
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This test method is under the jurisdiction ofASTM Committee F04 on Medical
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and Surgical Materials and Devices and is the direct responsibility of Subcommittee For referenced ASTM standards, visit the ASTM website, www.astm.org, or
F04.30 on Cardiovascular Standards. contact ASTM Customer Service
...
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