Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents

Importancia y uso:

4.1 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.

4.2 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.

Subcomité:

F04.30

Referida por:

F3036-21, F3067-14R21

Volúmen:

13.01

Número ICS:

11.040.20 (Transfusion, Infusion)

Palabras clave:

angioplasty; coronary artery; dimensional characteristics; dimensions; vascular stent;