Standard Guide for Radial Loading of Balloon-Expandable and Self-Expanding Vascular Stents

Importancia y uso:

4.1 Upon deployment, at the site of the vascular stenosis, the stent establishes the patency of the lumen until vascular remodeling occurs. The radial load acting upon the stent is imparted by vessel and lesion stretch. Additionally, the vessel might be affected by excursions due to pulsation (systolic and diastolic variation), muscle-skeletal interactions due to patient movement, as well as external sources (e.g., patient is struck in the neck during a car accident). The excursions vary in magnitude and type based on the location of the vessel.

4.2 In order to maintain vessel patency, the stent has to withstand the forces acting on it without experiencing excessive deformation, migration, or sustained collapse; therefore, it is required that the stent possess adequate resistance to these loads.

4.3 Depending on the type of device and the clinical concern, the resistance to these loads can be presented through multiple test outputs: radial strength, collapse pressure, or chronic outward force.

4.4 The guidelines presented here can be used in the development of test methods to determine the radial loading properties of stents. This guide provides examples of different test apparatus (equipment and tooling), radial loading curves, and calculations. Although the apparatus and methods presented can be used as a reasonable simulation of actual clinical use, they have not been demonstrated to predict the actual in vivo clinical performance of any stent.

Subcomité:

F04.30

Referida por:

F2514-21, F3036-21, F2477-24

Volúmen:

13.02

Número ICS:

11.040.40 (Implants for surgery, prothetics and orthotics)