A stent is a small, lattice-shaped, metal tube that is inserted permanently into an artery. The stent helps hold open an artery so that blood can flow through it.

Drug-eluting stents are mesh tubes that prop open narrowed arteries in the heart while slowly releasing a medication that prevents the build-up of scar tissue inside the stent.

A stent is used to hold open an artery that has become too narrow due to atherosclerosis. In atherosclerosis, plaque builds up on the inner walls of arteries, the blood vessels that carry oxygen-rich blood throughout the body.

As the artery walls thicken, the pathway for blood narrows. This can slow or block blood flow.

The Society for Cardiovascular Angiography and Interventions (SCAI) has released a clinical alert advising physicians on practical steps for reducing the risk of a rare but serious complication associated with the use of drug-eluting stents. The document follows hearings held by the Food and Drug Administration's Circulatory Systems Device Panel regarding the use of these devices. The panel supported the continued use of these devices but also suggested more research to determine whether the devices contribute to an increased likelihood of heart attack and death in complex heart disease patients who receive these stents (see http://www.fda.gov/cdrh/news/010407.html).

SCAI's clinical alert, published online in SCAI's official journal, Catheterization and Cardiovascular Interventions, focuses on the importance of careful patient selection, meticulous stent implantation, and consistent use of medications to prevent the delayed formation of blood clots that can block blood flow to the heart, a condition known as late stent thrombosis.

Lawyers are currently investigating the numbers of stent-related cardiac events linked to drug eluting stents. Drug eluting stents are also known as medicated or drug-coated stents. Medicated stents are, unlike bare metal stents, coated in drugs intended to inhibit cell growth to prevent restenosis (re-blocking of the artery).

Manufacturers of these stents include Boston Scientific (Taxus stent) and Cordis, a subsidiary of Johnson & Johnson (Cypher stent). Medicated stents are increasingly common, projected to represent 88% of all stents sold in the US in 2005.

The CYPHER® and TAXUS® Stents are drug eluting stents (DES), also known as medicated stents.   Unlike bare metal stents they are coated in medications intended to prevent restenosis (reblocking of the artery).   Medicated stents are increasingly common, representing approximately 90% of all stents sold in the U.S. in recent years.

Since the CYPHER® Sirolimus-eluting stent first received approval for use on April 24, 2003 and the TAXUS® Express Paclitaxel-eluting stent received approval for use by the FDA on March 4, 2004, over 1.5 million CYPHER® stents have been implanted in patients worldwide and over 3 million TAXUS® stents have been implanted in patients worldwide for treatment of coronary artery disease.  This has generated $5 billion in sales revenue to the manufacturers. 

Drug Eluting Stents have been linked to side effects such as thrombosis and severe allergic reactions.

How does it work?

The stent acts as a scaffold, remaining in place permanently to help keep the artery open.

A stent is inserted through a main artery in the groin (femoral artery) or arm (brachial artery) and threaded up to the narrowed section of the artery with a tiny catheter (balloon catheter.)

When it reaches the right location, the balloon is slightly inflated to push the plaque out of the way and expand the artery (balloon angioplasty). Some stents are stretched open (expanded) by the balloon at the same time as the artery. Other stents are inserted into the artery immediately after the angioplasty procedure.

Once in place, the stent helps holds the artery open so that the heart muscle gets enough blood.

FDA Statement

On September 14, 2006, the FDA released a Statement in response to inquiries asking for the agency’s position on adverse events related to Coronary Drug-Eluting Stents (DES).  The FDA confirmed that it was aware of recent data suggesting a significant increase in the rate of death and myocardial infarction (heart attack) possibly due to stent thrombosis (a blood clot in the stent) in patients treated with DES.

Recent studies have linked medicated stents with side effects such as thrombosis (blood clotting) and the need for long-term costly antiplatelet medication therapy in order to prevent thrombosis. The studies also found that the drug-coated stents may result in a higher death rate due to cardiac events such as heart attack when compared to metal stents without a drug coating.

If you or a loved one has suffered injuries or have legal concerns related to these products, please contact us via our Free Claim Evaluation via this Contact Us link.  You may be legally entitled to recover medical expenses, lost earnings, as well as compensation for physical pain and suffering, mental anguish and physical impairment.  For persons who have died, their surviving spouse or other family members often can bring a wrongful death action.

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