The standard “ASTM F2394-07 Standard guide for measuring the fixation of a balloon-expandable vascular stent mounted on a delivery system” developed by the American Society for Testing and Materials (ASTM) provides guidance for the design and development of pretest treatments, tests, and test endpoints to measure the stent fixation of preassembled, unsheathed, balloon-expandable stent delivery systems. This guideline is intended to assist researchers in the design, development, and in vitro characterization of preassembled, unsheathed, balloon-expandable stent delivery systems.
This standard covers the laboratory determination of the shear force required to dislodge or remove a balloon-expandable endovascular stent mounted in a delivery system. This standard recommends a number of options to consider when testing stent fixation. The options cover pretest treatments, possible stent fixation tests, and relevant test endpoints.
This standard covers in vitro bench test characterization only. The measured fixation levels and product design/process differentiation may be affected by, in particular, the choice of pretest procedures, the type of fixation test (e.g., stent retention method), and the test endpoint. In vivo characteristics may also differ from in vitro results.
This standard does not cover all possible pretesting procedures, stent fixation tests, or test endpoints. It is intended to provide a starting point for selecting and investigating fixation testing options. Additionally, this standard does not specify a method for mounting the stent in the delivery system.
The fixation of the endovascular stent on the balloon is a critical parameter to ensure safe delivery of the stent to or from the treatment site. This standard is designed for researchers and manufacturers to develop and select pretest treatments, tests, and test endpoints to measure stent fixation (displacement distances and displacement forces).
This guideline can be used to investigate which practical combinations of in vitro tests best characterize clinical scenarios. Additionally, this standard should be used with discretion when selecting fixation tests and evaluating results due to the numerous possible combinations of clinical conditions, failure modes, and stent delivery system designs.
This guideline can be used to develop a test to meet the requirements of the traceability section of the standard “EN 14299 Non-active surgical implants - Particular requirements for cardiac and vascular implants - Particular requirements for arterial stents”. At the same time, this standard can be used to develop a test to meet section VII-C-8 of the CDRH Guidance document.
There are two failure modes associated with this standard: the stent dislodges from the catheter, or the stent becomes dislodged or deformed on the catheter such that balloon inflation does not produce an acceptable stent shape in the appropriate position. Based on reported clinical events, there are three causes for these two failure modes:
Among the numerous testing, measurement, analysis and evaluation studies that our organization has provided for businesses in various sectors, our organization also provides testing services defined in the standard “ASTM F2394-07 Standard Guide for Measuring the Fixation of Balloon Expandable Vascular Stent Mounted on the Delivery System” with its trained and expert staff and advanced technological equipment.
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