USFDA approved EverFlex Self-Expanding Peripheral Stent System of ev3, Inc...

Product Name: EverFlex Self-Expanding Peripheral Stent System
Manufacturer: ev3, Inc.
Address: 3033 Campus Drive, Suite #N550, Plymouth, MN 55441
Approval Date: October 10, 2014

What is it?

The EverFlex Self-Expanding Peripheral Stent System is a thin, flexible, metal mesh tube that is implanted in the arteries that supply blood to the pelvis and legs (iliac arteries). The System consists of two parts, the stent and the delivery system. 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 catheter.

How does it work?

• A catheter with a deflated balloon at its tip is inserted into a blood vessel in the groin and advanced within the vessel to the narrowed section of the iliac artery.
• The balloon is inflated within the narrowed artery to open the artery by pushing the fatty material (plaque) against the artery wall (balloon angioplasty).
• The angioplasty balloon and its catheter are removed; then the EverFlex Self-Expanding Peripheral Stent System is advanced through the same blood vessel and positioned within the expanded artery.
• After it is positioned in the artery, the stent opens automatically over the blockage and is placed in the artery by withdrawing the outer tube (sheath).
• The delivery system is removed, and the stent remains permanently implanted in the iliac artery and acts as a support for the newly-opened section of the artery.

When is it used?

The stent is used in patients who have a narrowing in their iliac arteries caused by atherosclerosis - the collection of plaque along the lining of the arteries.

What will it accomplish?
Once in place, the stent permanently holds open a narrowed iliac artery and improves blood flow to the pelvis and legs.

When should it not be used?

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:

• Cannot take medicines that thin the blood or prevent blood clots.
• 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.

Approval Letter: CLICK HERE TO VIEW/DOWNLOAD