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U.S. Department of Health and Human Services

Medical Devices

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S.M.A.R.T.™ Nitinol Stent System / S.M.A.R.T.™ Control™ Nitinol Stent System - P020036

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: S.M.A.R.T.™ Nitinol Stent System and S.M.A.R.T.™ Control™ Nitinol Stent System
Manufacturer: Cordis Corporation
Address: 14201 N.W. 60th Avenue, Miami Lakes, FL 33014
Approval Date: August 12, 2003
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf2/P020036a.pdf

What is it and when is it used? The stent systems include a small, thin, flexible, metal, mesh tube (a stent), and a long flexible tube (a delivery catheter) used to deliver the stent to a specific area inside an artery (the iliac artery) that runs through the pelvic area. This stent is used to treat atherosclerotic disease of the iliac arteries. The disease causes the buildup of material (plaque) in the artery wall causing the opening in the artery to close down and slow the normal flow of blood.

How does it work? The stent is mounted on the end of the delivery catheter in a compressed state. The delivery catheter and stent are inserted into an artery in the leg and moved through the artery to the blocked area of the iliac artery. The compressed stent is then released from the delivery catheter in the artery. The stent expands and pushes the area with plaque outward against the walls of the artery. This opens the iliac artery to aid in the normal flow of blood. The delivery catheter is then removed, leaving the stent within the patient's artery.

What will it accomplish? The expanded stent within the blocked area of the artery helps to open the blocked area and keep it open, so that more blood can flow to the lower limb.

When should it not be used? It is recommended that these stents not be used in patients with a history of sensitivity to x-ray contrast or to nickel.

Additional information: The Summary of Safety and Effectiveness and labeling is available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=P020036