FDA Clears Self-Expanding Peripheral Stent System

Oct. 27, 2014 — The U.S Food and Drug Administration (FDA) cleared the EverFlex Self-Expanding Peripheral Stent System. The stent was developed by ev3, which is now a part of Covidien.

The thin, flexible stent is indicated for the iliac arteries that supply blood to the pelvis and legs. The stent is an implant made of a nickel-titanium alloy (nitinol) tubing and laser cut into a mesh shape. The stent is mounted in a long, thin, tube-like device called the delivery

The FDA said generally, patients who are not suitable candidates for balloon angioplasty are also not suitable candidates for stent placement. The EverFlex Self-Expanding Peripheral Stent System should also not be used in patients who:

• Have known allergies to the metals in the stent.
• Have a blockage that will not allow complete inflation of the angioplasty balloon or proper placement of the stent.
• Cannot take medicines that thin the blood or prevent blood clots.
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?For more information: www.accessdata.fda.gov