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: BridgeÔ Extra Support Over-the-Wire Renal Stent System
Manufacturer: Medtronic, Inc.
Address: 800 53rd Avenue Northeast, Minneapolis, Minnesota 55421
Approval Date: December 18, 2002
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf2/p020007a.pdf
What is it? A metal mesh tube (stent) and a delivery system, used to hold open the main artery in the kidney, called the renal artery, when it is blocked by a buildup of plaque. The delivery system is a guidewire and thin flexible tube (catheter) with a deflated balloon on the end. Using the delivery system, the physician inserts the stent through a small cut in a leg artery and threads it up to the narrowed or blocked renal artery.
When is it used? A physician may use this stent in a patient in whom another procedure, called balloon angioplasty, was not successful in opening up the renal artery.
How does it work? The physician
- inserts a wire to guide the stent to the proper location in the narrowed or blocked renal artery,
- slides the balloon catheter and stent over the guide wire,
- inflates the balloon to expand the stent and push the plaque against the renal artery wall, and
- removes the balloon catheter and guide wire.
The expanded stent opens the artery so blood can flow more freely to the kidney. The stent is permanent and the artery lining will grow over it in about 8 weeks.
What will it accomplish? The increased flow of blood to the kidney should reduce the risk of kidney failure, high blood pressure, stroke and heart attack in patients who have a narrowed or blocked renal artery.
When should physicians not use it? Physicians should not use the Bridge™ Extra Support Over-the-Wire Renal Stent System in patients
- who can be adequately treated with drugs,
- whose blockage is in a branch from the renal artery, where the balloon might not completely inflate,
- who have bleeding disorders, or
- who can be adequately treated by percutaneous transluminal renal artery angioplasty (PTRA), a procedure in which a balloon is used to enlarge the opening in the artery.
Additional information: Summary of Safety and Effectiveness and labeling are available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p020007