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Abbott stent approval expanded

The US Food and Drug Administration has approved Abbott's RX Acculink carotid stent for use in patients at standard risk of stroke

The US Food and Drug Administration (FDA) has approved a new use for Abbott's RX Acculink carotid stent, clearing the product for use in patients at standard risk of stroke, a group that represents more than 60 per cent of US patients with carotid artery disease.

The latest FDA approval allows the device to be marketed for all patients at risk of stroke due to clogging of the ceratoid arteries in the neck that carry blood to the brain. The FDA approved the stent in 2004 for patients with clogged carotid arteries who were at high risk of complications if they underwent carotid endarterectomy, a surgical procedure that involves scraping the plaque out of the neck artery.

"Today's action expands the indication for use of the stent to include all patients with clogged carotid arteries who are at risk for stroke, not just those who are not good candidates for surgery," the FDA explained. With the new approval, the product has become the only carotid stent system approved for use in both high-risk and standard-risk patients.

The FDA's decision follows a positive recommendation from an advisory committee that was made at a meeting in late January. The advisors voted that the stent was generally safe and effective for the new indication, but recommended a long-term follow-up study.

Abbott's marketing application included a 10-year study of 2,502 patients who were treated and followed for at least 12 months at 119 clinical sites in the US and Canada.

The study, which was funded partly by the National Institutes of Health, found that patients treated using the RX Acculink had a similar combined rate of death, stroke, and heart attack as patients treated with surgery. Known as the CREST study, the research was the largest prospective study ever conducted to compare carotid artery stenting to surgery.

In line with the advisory committee's recommendation, the FDA is requiring Abbott to conduct a post-approval study following patients for at least three years. The study will also evaluate treatment response in patients aged 80 years and over; determine whether treatment success is linked to physician experience with the product; and observe whether patients who show symptoms of a clogged carotid artery have a different treatment outcome than those who do not.

The post-marketing trial, which Abbott said will begin later this year, will assess clinical outcomes at 30 days and then annually over the study period.

Abbott also said the company will seek expanded Medicare coverage for carotid stenting based on the CREST trial results.

9th May 2011

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