Consumer Information on: Assurant® Cobalt Iliac Balloon-Expandable Stent System - P110011
Posted Nov 04 2011 12:00am
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: Assurant® Cobalt Iliac Balloon-Expandable Stent System Manufacturer: Medtronic Vascular Address: 3576 Unocal Place, Santa Rosa, CA 95403 Approval Date: October 26, 2011 Approval Letter:http://www.accessdata.fda.gov/cdrh_docs/pdf11/p110011a.pdf
What is it? The Assurant® Cobalt Iliac Balloon-Expandable Stent is a thin, flexible metal mesh tube that is implanted in the large arteries that supply blood to the pelvis and legs (iliac arteries).
How does it work?
The Assurant® Cobalt Iliac Balloon-Expandable Stent is mounted onto a stent delivery catheter and held in place by an outer cover until it is positioned in the artery.
After the catheter is positioned in the narrowed area of the artery, the stent is then inserted into the artery by inflating the nylon balloon that is attached to the end of the catheter.
The stent holds open the arteries to increase blood flow.
Once the stent is inserted, the balloon is deflated and stent delivery catheter is removed.
The stent remains permanently implanted in the iliac artery and acts as support for the newly opened section of the artery.
When is it used? The Assurant® Cobalt Iliac Balloon-Expandable Stent is used to treat patients with narrowing of an iliac artery caused by atherosclerosis , the collection of plaque, a sticky substance made up of fat, cholesterol, calcium and other substances found in the blood, along the lining of the arteries.
What will it accomplish? The inside lining of the artery will grow over the stent approximately eight weeks after it is implanted. Once in place, the stent holds open a narrowed iliac artery and improves blood flow to the legs.
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: Assurant® Cobalt Iliac Balloon-Expandable Stent System
Manufacturer: Medtronic Vascular
Address: 3576 Unocal Place, Santa Rosa, CA 95403
Approval Date: October 26, 2011
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf11/p110011a.pdf
What is it? The Assurant® Cobalt Iliac Balloon-Expandable Stent is a thin, flexible metal mesh tube that is implanted in the large arteries that supply blood to the pelvis and legs (iliac arteries).
How does it work?
When is it used? The Assurant® Cobalt Iliac Balloon-Expandable Stent is used to treat patients with narrowing of an iliac artery caused by atherosclerosis , the collection of plaque, a sticky substance made up of fat, cholesterol, calcium and other substances found in the blood, along the lining of the arteries.
What will it accomplish? The inside lining of the artery will grow over the stent approximately eight weeks after it is implanted. Once in place, the stent holds open a narrowed iliac artery and improves blood flow to the legs.
Additional information: Summary of Safety and Effectiveness and labeling are available online.
Other Resources: