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: NIRflex™ Premounted Coronary Stent System
Manufacturer: Medinol Ltd.
Address: PO Box 58165, Kiryad Atridim, Bldg. 3, Entrance 2, 5th Floor, Tel Aviv, Israel
Approval Date: October 24, 2003
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf2/P020040a.pdf
What is it? The NIRflex™ Premounted Coronary Stent System (coronary stent system- CSS) is an expandable stainless steel tube (a stent), attached to a deflated balloon at the end of a long flexible tube (delivery catheter). The stent is used to open an abnormally narrowed vessel (artery) and it becomes permanently implanted to hold open the artery that was once narrowed by the accumulation of plaque in the artery wall.
The device is used for increasing the opening in coronary arteries in patients who do not have enough blood flow to the heart (ischemic heart disease) due to:
- the buildup of cholesterol and plaque in the coronary artery wall, and
- a build up that has happened again in the coronary arteries.
For a picture of a stent placement go to: http://www.nlm.nih.gov/medlineplus/ency/presentations/100160_6.htm
How does it work? The NIRflex™ Premounted Coronary Stent is a small, mesh, metal tube, used to hold open a narrowed artery. The stent is attached to a balloon at the end of a delivery catheter. The delivery catheter delivers the stent to the narrowed area of the artery where the stent is expanded. This action opens the artery, allowing increased blood flow. The stent is a permanent implant and over time is covered by a thin layer from the lining of the artery wall.
When is it used? The CSS is indicated for improving the opening in coronary vessels in patients with symptoms of a lacking oxygen-rich blood flowing to their heart through the coronary vessels
What will it accomplish? After 30 days, patients treated with this CSS show an increase in blood flow to their heart. The long-term outcome (beyond 6 months) for this permanent implant is unknown at present.
In a recent study of 201 patients, early results showed that 196 patients treated with this CSS had a successful delivery and expansion of the stent to the intended site. These 196 patients also achieved less than 50% residual narrowing in the coronary arteries. Success for the device and the procedure is considered when there are no major adverse cardiac events occurring in the hospital, such as death, heart attack, or repeat plaque buildup in the artery at the site of the early narrowing.
When should it not be used?
The CSS should not be used for patients:
- where blood thinning therapy (antiplatelet and/or anticoagulant) is not indicated,
- who are judged to have a condition of the artery that prevents complete inflation of the balloon, or
- who have known allergies to stainless steel.
Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=P020040