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Drug Coated Stents
Blood Clots Four to Five Times More Likely With Drug Coated Stents Than Older Bare Metal Stents
A study published in the December 2006 issue of the American Journal of Medicine, found that blood clotting is four to five times more likely to occur with the newer drug eluting coronary heart stents than with the older bare metal stents. The increased risk of blood clotting (thrombosis) is associated with an increased risk of heart attack and death. The two FDA approved drug eluting stents are Johnson & Johnson’s Cypher Stent (emited sirolimus) and Boston Scientific’s Taxus Stent (emits paclitaxel).As a result of this study, the researchers have recommended that patients with Johnson & Johnson Cypher stents should take anti-clotting drugs for two to three months following implantation, and those patients with the Boston Scientific Taxus stents should take anti-clotting drugs for six months or more following implantation. Anti-clotting or anti-platelet drugs such as Plavix (clopidogrel) and aspirin are often prescribed after the stent procedure.
Drug Coated Stents and Heart Attacks
A second study published in 2007 found that drug coated stents posed a particular risk to patients with a history of heart attacks. The Drug Coated Stents study, conducted by researchers at the Bichat-Claude Bernard Hospital in Paris, France, analyzed a patient database from 94 hospitals in 14 countries. The patients involved in this research had heart attacks that had resulted from a blood clot that completely blocked blood flow to the heart – the most damaging type of heart attack. Patients with the drug coated stents were five times more likely to die than patients who received the bare metal stents. The researchers hypothesize that heart attack victims might have problems with the drug coated stents because blood vessels narrow following such a cardiac episode. This can lead to a gap around the stent – an ideal place for a blood clot to form.
Legal Help for Drug Coated Stent Patients
If you or a loved one suffered blood clotting (thrombosis) after having a drug-eluting stent implanted following angioplasty surgery, you are encouraged to contact Parker & Waichman, LLP for a FREE case evaluation by a qualified defective medical device attorney. Call 1-800-LAW-INFO (1-800-529-4636) or fill out our form at the right. Our defective medical device lawyers are working with patients injured by Boston Scientific TAXUS Express Stents and Johnson Johnson Cypher Stents.
Angioplasty Procedure
Drug coated stents were developed to address the problem of restenosis, or reclosure of an artery following angioplasty. In angioplasty, a balloon is inserted through an incision in the groin or arm and moved to the place of the blockage. It is inflated in order to expand the opening and allow for more regular blood flow. Following this, a stent is then inserted through the vessel to the place cleared by the balloon. The stent holds the artery open, acting as a scaffolding supporting the vessel walls. With the older bare metal stents, the artery would heal around the device, and the resulting scar tissue would sometimes reblock the artery (restenosis). Drug coated stents were then developed. The drugs that are emited from the polymer are intended to suppress the formation of scars and prevent the arteries from closing again. Because the drugs prevent the artery lining from healing around the device, the device creates a location for blood clots to form. Heart attacks are often the result of blood clots in stent patients. Other companies, Abbott Laboratories and Medtronic, are developing stents designed to gain a piece of the $6 billion annual stent market. Stents which dissolve are also under development.
Drug Coated StentsRSS Feed
Cypher Stent Ad Criticized
May 15, 2008 | Parker Waichman Alonso LLP
A 60-second television ad for the Cypher drug coated stent—made by the Cordis subsidiary of Johnson & Johnson—is under fire. It seems the ad failed to fully warn consumers about the potential dangers of receiving a stent, according to an article published by The New England Journal of Medicine. The Journal says the ad promotes the Cypher stent’s potential benefits but minimizes its risks and this may be deceptive and should be reviewed by federal regulators.The...
Drug Coated Stent Debate Yet to be Resolved
May 12, 2008 | Parker Waichman Alonso LLP
Experts continue to disagree on the usefulness and safety of drug coated stents. Stents are an important element in heart-disease treatment. Tiny wire-mesh tubes, stents prop open arteries once doctors clear them of blockages. Some stents have a drug coating meant to keep vessels from re-clogging following balloon angioplasty procedures. Bare-metal stents tend to re-clog more often than drug-coated stents, so physicians are quick use drug-coated stents, even in...
Why the Rush to Approve Drug Coated Stents?
Apr 25, 2008 | Parker Waichman Alonso LLP
The new Xience heart stent out-performed the more popular Taxus heart stent in a one-year trial; however, experts disagree on whether stent science is moving too fast and doctors are concerned over the recent discovery that blood clots can form at the site of drug-coated stents long after implantation.Stents are tiny wire-mesh tubes used to prop open arteries after doctors clear them of blockages. Some stents have a drug coating meant to keep vessels from re-clogging following balloon...
FDA Releases Drug Coated Stent Guidelines
Mar 27, 2008 | Parker Waichman Alonso LLP
Drug coated stents should be subject to more stringent clinical trials before approval, and makers of such devices should conduct long-term follow-up studies after drug coated stents are brought to market, according to the Food & Drug Administration (FDA). Those recommendations were part of the FDA's proposed guidelines for drug coated stents that were released yesterday. While the proposal is not binding, companies often seek the FDA's advice during product development, and...
Bypass More Effective than Drug Coated Stents For Clogged Arteries
Jan 24, 2008 | Parker Waichman Alonso LLP
Drug Coated Stents don’t work as well as traditional bypass surgery. A new study, published in The New England Journal of Medicine states that patients with multiple clogged arteries are better off going through bypass surgery than being implanted with heart stents. While the findings are not likely to settle the ongoing dispute between cardiac surgeons, who perform bypasses, and the interventional cardiologists who implant stents, it does provide additional fodder to those...
Drug Coated Stents
Quick Facts
Drug Coated Stents Reference Guide
Manufacturers
Johnson & Johnson
Boston Scientific
Status
Express recalled 6/13/04
Taxus recalled 7/04 & 8/04
Cypher FDA warning 7/03 & 10/03
Approved Uses
Angioplasty procedures
Complications
Death
Blood clots
Thrombosis
Heart attacks
Stroke
Boston Scientific Express Stent
Boston Scientific Taxus Stent
Johnson Johnson Cypher Stent
Blood Clots
Heart Attacks
Stroke
Diseases
Defective Medical Devices
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