FDA Sanctions Wider Use of Carotid Stent
Now approved for all individuals with carotid artery stenosis at risk for stroke
FRIDAY, May 6 (HealthDay News) -- More people with carotid artery stenosis 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 carotid artery stenosis who are at risk for stroke, not just those who don't qualify for artery-clearing surgery, the agency said in a news release.
In 2004, the RX Acculink stent was first FDA-approved for people at high risk of complications if they underwent 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 that 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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