| Abdominal aortic aneurysms (AAA) affect 2-3% of the population in the United
States and 15,000 fatalities are attributed to their rupture every year. The current
index used to make clinical decisions about aneurysm management is the diameter.
However, size is only one of many determinants for rupture. The current study
develops techniques to calculate wall normal unit vectors and wall shear stresses in
three models that replicate the complicated in vivo aneurysm geometry of specific
patients. Under mean physiological blood flow (Re = 500), a maximum shear stress
of 0.72 dyne/cm2 occurs at the proximal end of the aneurysm along the right sagittal
wall in model 1. A maximum shear of 3.13 dyne/cm2 is found along the distal right
coronal wall of model 2 under physiological peak blood flow (Re = 2500) simulation.
Management of conditions such as AAA requires the use of specialized medical
devices. Owing to the crucial role of medical devices in ameliorating human lives,
device marketing is subject to stringent regulation. Though the U.S. FDA is viewed
in high regard, the EU system of medical device regulation has become more
prominent in recent years. The EU council promotes free trade by encouraging
member states to uphold the "Internal Market." The economic emphasis of EU
medical device regulation has led to a streamlined, more cost-effective system. However, recent EU legislation threatens the trend of U.S. companies conducting clinical trials in Europe.
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