Standard Guide for Testing Absorbable Stents

Importancia y uso:

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.

Subcomité:

F04.30

Referida por:

F3510-21, F0561-19

Volúmen:

13.02

Número ICS:

11.040.40 (Implants for surgery, prothetics and orthotics)

Palabras clave:

absorbable; bend testing; conditioning; degradable; elastic recoil; fatigue; radial loading; securement; stent; stent graft; vascular scaffold;