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