English to Russian Medical Medical: Instruments In vitro testing

Accelerated Durability Testing was performed to meet the objective of FDA 1545 “Non-Clinical Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems” requirements for in vitro mechanical fatigue testing. Fatigue testing was performed to demonstrate durability of the 3.5x25mm Shield when subject to 40 million cycles of simulated physiological conditions. A 3.5x25mm Shield was chosen for this test since it was determined to be the worst case mean and cyclic strain condition in the finite element analysis. This testing was performed in 37C saline in a curved radius of 15 mm to simulate an equivalent 1year life test.

• Finite Element Analysis
Finite element analysis of the 3.5mm and 4.0mm diameter Shields was performed to determine safety from a theoretical perspective for their respective operational range of expansion diameters. The results indicate the 3.5mm and 4.0mm Shields are fatigue safe.