THURSDAY, July 3 (HealthDay News) -- The Xience drug-coated stent, used to prop open a blocked or narrowed artery in people with coronary artery disease, has been approved by the U.S. Food and Drug Administration, maker Abbott Laboratories said.
A stent is a metal-mesh tube that's inserted into the artery. The drug, everolimus, helps prevent the blood vessel from becoming blocked again with plaque. A blocked or narrowed artery reduces blood flow to the heart, which can cause chest pain and heart attack.
Studies released two years ago concluded that drug-coated stents could promote a greater number of dangerous blood clots than use of the stents by themselves. Although Abbott said clinical testing on its stent found no such issue, the company will be required to monitor 5,000 patients in whom the stent is implanted for five years or longer, the Bloomberg news service reported.
In a statement, Abbott said clinical testing showed its stent reduced by 45 percent the risk of a major cardiac event such as heart attack, compared with a competing stent.
The product will be made available in the United States immediately, the company said.
The Society for Vascular Surgery has more information about stents.