THURSDAY, April 24, 2003 (HealthDayNews) -- A drug-releasing stent that helps keep unclogged arteries from re-blocking has been approved by the U.S. Food and Drug Administration (FDA).
The Cypher stent -- a drug-coated metal tube that is inserted into a patient's artery to prop it open -- was introduced in April 2002 and is available in almost 60 other countries, according to its manufacturer, Cordis Corp.
Every year, more than 5 million Americans are treated for coronary artery disease, and about 200,000 of them must be treated again within a year for recurring blockage. In clinical trials involving 1,400 patients, the drug-treated stent reduced the incidence of re-blockage (restenosis) by about two-thirds when compared to a metal stent, says Cordis, part of Johnson & Johnson Co.
For every 100 patients treated with the Cypher stent, there were 25 fewer hospitalizations than when a conventional stent was used, Cordis adds.
The drug -- sirolimus -- is used to prevent scar tissue growth, a frequent reaction to original surgery to unclog arteries. The drug is marketed by Wyeth Pharmaceuticals as Rapamune.
People who are allergic to stainless steel or sirolimus should not receive the new stent, the FDA says. The agency is requiring Cordis to conduct additional studies to evaluate the product's long-term effectiveness.
More information
Here is the FDA Talk Paper announcing the approval. For more on coronary artery disease, visit the National Institute of Medicine.
