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New Device Approval

IntraStent® DoubleStrut™ Stent- P030045

This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.

Product Name: IntraStent DoubleStrut Stent
Manufacturer: ev3 Inc.
Address: 4600 Nathan Lane North
Plymouth, MN 55442-2920
Approval Date: June 8, 2004
Approval Letter: http://www.fda.gov/cdrh/pdf3/p030045a.pdf

What is it? The IntraStent DoubleStrut Stent is a thin, flexible metal mesh tube that can be implanted in the large arteries that supply blood to the pelvis and legs (iliac arteries). The IntraStent acts like a scaffold by holding an iliac artery open to maintain adequate blood flow.

When is it used? The IntraStent is used to treat patients with narrowing of an iliac artery caused by atherosclerosis, the collection of fatty substances such as cholesterol that forms “plaque” along the lining of the arteries.

How does it work?

• The IntraStent is mounted on a deflated balloon catheter (stent delivery catheter) that holds the stent in place until it is positioned in the artery. The delivery catheter and stent are inserted and positioned in the narrowed iliac artery.
• The balloon on the stent delivery catheter is inflated to expand the stent after it is positioned in the narrowed area of the artery.
• The stent placement increases blood flow by holding the artery wall open.
• Once the stent is fully expanded, the balloon is deflated and the stent delivery catheter is removed.
• The stent remains permanently implanted in the iliac artery and acts as a support for the newly opened section of the artery.

What will it accomplish? The inside lining of the artery will grow over the stent approximately 8 weeks after it is implanted. Once in place, the stent acts as a scaffold to:

• hold open a narrowed iliac artery, and
• improve blood flow to the legs.

When should it not be used? There are no contraindications for this device.

Additional information: Summary of Safety and Effectiveness and labeling will be available at: http://www.fda.gov/cdrh/pdf3/p030045.html

Other:

• FDA information on stents with illustrations on stent placement:
  http://www.fda.gov/hearthealth/treatments/medicaldevices/stent.html
• FDA information on atherosclerosis:
  http://www.fda.gov/hearthealth/conditions/atherosclerosis.html
• American Heart Association information on peripheral heart disease (PVD): http://www.americanheart.org/presenter.jhtml?identifier=4692

Updated June 14, 2004

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