FDA Sanctions Wider Use of Carotid Stent
FRIDAY May 6, 2011 -- 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.
To learn more about carotid artery disease, visit Medline Plus.
Posted: May 2011