Pulsatile durability testing is a time-consuming part of the vascular stent approval process. Accelerated test designs can deliver a high throughput when every specimen counts.
Pete Bailey, Instron
There are many quality controls applied to the design and release of coronary and other vascular stent devices, but a proof test of pulsatile durability, such as those laid out in ASTM F2477-19 (i.e. fatigue in diametral distension), is probably one of the most unavoidably time-consuming.
This is a simple “test to success” methodology, but it ensures a clear benchmark result of pass/fail. The test must simulate the dilational loading of 10 years of service at 72 B.P.M., meaning that the device must survive 380 million cycles in saline or simulant fluid. To demonstrate statistical confidence that this is a guaranteed safe life, it is generally considered necessary to test a representative sample of 30 specimens, all of which must pass.