Drug-Coated Stents Overview
What is a Stent?
A stent is a small,lattice-shaped, metal or plastic tube inserted permanently into an artery orblood vessel. A stent is used to open anartery that has become too narrow due to atherosclerosis, a condition in whichplaque builds up on the artery's inner walls blocking blood flow. Stents aretypically placed inside a coronary (heart) artery after a balloon angioplastyprocedure in order to prevent "restenosis"(re-closing or re-blocking of the artery).
What is a Drug-CoatedStent?
A drug-coated (also called "drug-eluting") stent slowly releases drugs that potentially prevent arterialscarring, and reduce the possibility of restenosis.
The U.S. Food and Drug Administration has approved twobrands of drug-coated stents, among others: the Cypher Sirolimus-Eluting CoronaryStent manufactured by CortisCorporation (a division of Johnson & Johnson), and the TaxusExpress Paclitaxel-Eluting Coronary Stent System manufactured by Boston ScientificCorporation. Click herefor a list of recently-approved medical devices from the FDA, with links toconsumer information.
Drug-Coated Stents Recent News
In a recent statement (updated September 14, 2006), the FDAsaid that it has been closely monitoring drug-coated stentssince they entered the U.S.market in 2003 and 2004, and will continue to do so. New data suggests that there is a small butsignificant risk of stent thrombosis (blood clottingin the stent). However, the FDA does not yet haveenough information to draw any conclusions regarding the risk and causes of stent thrombosis.
The FDA believes that coronary drug-coated stents remain safe and effective when used for the FDA-approvedindications. A public panel meeting of outside scientific experts is scheduledto review all the data and to make recommendations about what steps should betaken. Click here to read the FDA'sstatement on coronary drug-coated stents.
Drug-Coated Stents Risks
Risks of stentsand stent placement may include:
- Infection
- Blood clot
- Bleeding
- Rupture of the duct or vessel when the stent is inserted
- Stent migration (stent moving out of place)
- Allergic reaction to stent material
- Allergic reaction to the drug used in a drug-coated stent
- In-stent restenosis (the inside of the stent becomes clogged) -- the risk is higher in those with non-drug-coated stents
Other rare complications of coronary stentsinclude chest pain, heart attack, or tearing of the blood vessel.
Drug-coated stents may haveadditional risks. Ask your healthcareprofessional about the risks associated with stentsand drug-coated stents.
When Should Drug-CoatedStents Not Be Used?
Drug-coated stents may not beadvised for patients who have had recent heart surgery, or women who arenursing or pregnant. Patients who receive a drug-coated stentmay need anti-platelet drugs for at least several months.
Stents should not be used inpatients who cannot tolerate angioplasty, or who are sensitive (allergic) tothe stent materials. They should not be used inpatients who cannot be placed on blood-thinning (anti-platelet) medication.
The safety and effectiveness of a drug-coated stent have not been studied in patients who have a blockagein a heart bypass graft, who are actually having a heart attack, or who hadprevious intravascular radiation treatment.
Drug-coated stents have additionalrestrictions. Your healthcare professional can tell you more about whether ornot you are an appropriate candidate for this technology.
Drug-Coated Stents - GettingLegal Help
A medical device manufacturer has a duty to make itsproducts as reasonably safe as possible, and to inform the medical communityand the public of any known risks associated with its products. If amanufacturer fails to do so, it can be held legally responsible if patients areinjured as the result of inadequate warnings or the unreasonably dangerousnature of the medical device, under a legal theory called "productliability."
If you or a loved one have been implanted with a drug-coatedstent and are experiencing any unusual healthproblems or medical conditions, you should contact your doctorimmediately. You may also wish to meet with an experienced attorney todiscuss your options and to protect your right to a legal remedy for anyinjuries caused by a drug-coated stent.