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Stents are thin, flexible mesh tubes that can be implanted in the large arteries that
supply blood to the heart, head, pelvis and legs. They act as scaffolds to hold the arteries
open and maintain adequate blood flow in patients who have atherosclerotic plaques (“hardening
of the arteries”). A stent is inserted by placing it over a tiny balloon at the end
of a thin, flexible wire called a delivery catheter. The catheter is inserted into the
artery that needs the stent. When the stent is in place, the balloon is inflated, expanding
the stent into the artery wall, where it will remain. The balloon is then deflated and the
catheter is removed from the body. FDA physiologists, material scientists, clinicians, analytical
chemists, mechanical and chemical engineers and biostatisticians all play a role in making
sure that stents are safe and effective.