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ASTM F2477: In Vitro Pulsatile Durability Testing of Vascular Stents


By Engaged Expert

Maciej Jakucki

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Maciej Jakucki has performed and managed a wide variety of medical testing projects and programs to meet FDA and CE requirements.

Since the first angioplasty in 1977, stents have become commonly used in airways, arteries, and veins throughout the human body. Testing according to ASTM F2477 helps ensure vascular stents are fit for purpose.  

There are several types of stents, such as bare metal stents, drug-eluting stents, and bioresorbable stents. Stent grafts are used to seal aneurysms by providing a new pathway for blood flow. Stent grafts typically consist of a self-expanding stent frame that is covered with a material such as fabric to reduce pressure on the aneurysm.

While there are many types of stents with varying clinical outcomes, all are tested using the ASTM F2477 methodologies.

Pulsatile durability testing according to ASTM F2477

ASTM F2477 is the standard test method for the in vitro pulsatile durability testing of vascular stents, applicable to balloon-expandable and self-expanding stents made from metals and metal alloys, and is an FDA recognized consensus standard. The test methods evaluate stent durability when samples are deployed into a mock vessel subjected to hydrodynamic loading that simulates the loading and/or change in diameter that the device will experience in vivo.

Element has extensive expertise in pulsatile durability testing and has pioneered the field through the patented development of the ElectroForce Stent/Graft Tester.

To learn more about testing stents according to ASTM F2477, please complete the form below and download our free article. 

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