U.S. panel backs Abbott carotid stent for more patients
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U.S. health advisers backed Abbott Laboratories’ RX Acculink carotid stent on Wednesday as another option for a wider group of patients whose clogged neck arteries put them at risk for a stroke.
While there are concerns about side effects such as stroke, the U.S. Food and Drug Administration’s advisory panel said the device was a promising therapy for more potential patients, voting 7-3 to recommend wider approval. One member abstained.
The FDA will consider the panel’s recommendation before later making its final decision, which the company expects in the second half of 2011.
Thomas Simon, the panel’s nonvoting patient representative, said wider use would be “a win-win-win situation” giving patients another choice in addition to the more invasive surgery or diet, exercise and medication.
Acculink is already approved in the United States for patients who face a greater risk of complications with another surgical procedure that opens up the neck and scrapes out built-up fat deposits in the carotid artery.
Abbott is seeking expanded approval to market the stent to a wider group of patients who don’t face more potential for serious side effects from the alternative surgery, known as carotid endarterectomy.
Its chief medical officer, Chuck Simonton, told FDA’s advisers that the stent had “comparable outcomes” to more invasive surgery and worked for about as long to keep arteries clear. Abbott also proposed continuing to study the less risky patients if FDA allows wider use.
Which procedure is better is up for debate.
Carotid stenting is a less invasive procedure that involves threading a wire mesh stent up into the neck, while carotid endarterectomy requires an incision in the neck, cutting open the artery and scrapping off the plaque.
Studies have shown that neck stents are more likely to cause stroke or death while surgery can lead to more nerve damage and heart attacks.
FDA staff scientists told the panel that the company’s data showed Acculink was on par with the surgical alternative although both treatments led to different complications such as stroke and heart attacks seen in other studies.
The data was stronger for patients who exhibited fewer symptoms from their clogged carotid arteries than those who already show signs of cardiac trouble, the FDA scientists added.
Panel members told FDA they thought a longer, larger trial would be needed for additional data and that the stent’s label should mention various precautions about stroke and other potential complications in additional, less risky patients.
Wider approval is not expected to do much to boost Abbott’s bottom line, although Abbott has said it will seek additional Medicare coverage for the device if it wins FDA’s OK.
Globally, the overall carotid stent market is modestly growing and represents just a small part of Abbott’s vascular business, the company said earlier this week.
Shares of Abbott earlier closed down 2.5 percent at $46.75 on the New York Stock Exchange, largely in the wake of its cautious 2011 outlook and job cuts announced earlier on Wednesday.
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By Susan Heavey
GAITHERSBURG, Maryland
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