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E-LUMINEXX Vascular Stent - P080007

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 Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: E-LUMINEXX Vascular Stent
PMA Applicant: Bard Peripheral Vascular, Inc.
Address: 1415 W. 3rd Street, Tempe, AZ 85281
Approval Date: December 4, 2008
Approval Letter: http://www.fda.gov/cdrh/pdf8/P080007a.pdf

What is it? The E-LUMINEXX Vascular 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 E-LUMINEXX stent acts like a scaffold by holding an iliac artery open to maintain adequate blood flow.

When is it used? The E-LUMINEXX Vascular Stent 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 E-LUMINEXX Vascular Stent is mounted onto a stent delivery catheter and held in place by an outer sheath until it is positioned in the artery. The delivery catheter and stent are inserted and positioned in the narrowed iliac artery.
• The stent is deployed by retracting the outer sheath 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 deployed, 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? Use of the E-LUMINEXX Vascular Stent is contraindicated in the following cases:

• Stenoses that cannot be dilated to permit passage of the delivery system.
• Stenting of an arterial vessel where leakage from the artery could be exacerbated by placement of a stent.
• Patients with bleeding disorders.

Additional information: The Summary of Safety and Effectiveness and Labeling will be available online.

Other:

• FDA information on stents with illustrations on stent placement
• FDA information on atherosclerosis
• American Heart Association information on peripheral heart disease (PVD)

Updated December 11, 2008

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