FRIDAY, May 6 (HealthDay News) -- More people with a clogged
neck artery are now candidates for the RX Acculink carotid stent,
the U.S. Food and Drug Administration said Friday.
The agency widened approval for the device to include all people
with a clogged carotid artery who are at risk for stroke, not just
those who don't qualify for artery-clearing surgery, the agency
said in a news release.
Carotid arteries on both sides of the neck feed blood to the
brain. If clogged with fatty deposits called plaque, the resulting
lack of blood could lead to a stroke.
In 2004, the RX Acculink stent was first FDA-approved for people
at high risk of complications if they had artery-clearing surgery
known as carotid endarterectomy.
Earlier this year, an expert panel advising the FDA concluded
that RX Acculink was generally safe and effective for the new group
of candidates. But the panel recommended long-term studies to
evaluate the stent's use when combined with another device designed
to capture any debris that might break away from the clogged area,
the FDA said.
The agency said as a condition of approval, it's requiring
device maker Abbott Vascular to conduct a post-approval trial of at
least three years. The company is based in Santa Clara, Calif.
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