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: MULTI-LINK VISION™ RX Coronary Stent System
MULTI-LINK VISION™ OTW Coronary Stent System
Manufacturer: Guidant Corporation
Address: 3200 Lakeside Drive, Santa Clara, CA 95054
Approval Date: July 16, 2003
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf2/p020047a.pdf
What is it? The MULTI-LINK VISION™ Coronary Stent Systems (CSS) are composed of two main components: the stent and the delivery system. The MULTI-LINK VISION™ stents are small, latticed metal tubes made from L-605 cobalt chromium (CoCr) alloy. The delivery system, used to deliver the stent through a blood vessel, is a catheter, a thin, flexible wire-like tube with a small balloon attached.
How does it work? The catheter is inserted into a blood vessel in the patient’s groin area and threaded up into the affected artery, where it is maneuvered across the area of blockage (called a lesion). The balloon is then inflated, causing the stent to expand and press against the artery wall. Once the balloon has been deflated and withdrawn, the stent stays in place permanently. For a drawing of the heart please go to: http://www.nlm.nih.gov/medlineplus/ency/imagepages/1056.htm
When is it used? Coronary artery disease (CAD) is caused by a build-up of fatty substances like cholesterol that cause the artery to narrow and blood flow to slow. When the coronary arteries become partially blocked by fatty deposits, the heart does not receive enough oxygenated blood. To alleviate this problem, a physician will recommend the most appropriate form of treatment. If medical therapy or bypass surgery is not deemed appropriate at this stage, angioplasty (insertion of a balloon to open the artery) or the implantation of a stent like this one are the most likely alternatives.
What will it accomplish? The stent is intended to stay in place permanently and help hold the blood vessel open, improving the flow of blood and relieving the symptoms of coronary heart disease.
When should it not be used? The Guidant MULTI-LINK VISION™ Stent is not intended for use
- in patients who cannot tolerate blood-thinning medications (also called anti-platelet or anti-coagulant therapy), or
- for patients judged to have a lesion that prevents complete inflation of an angioplasty balloon.
Additional information: Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p020047