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.
More information
The
Society for Vascular Surgery has more information
about stents.
