Abbott's Neck Stent Met Primary Goals in Study, FDA Staff Says in Report
January 24, 2011
By Molly Peterson
Abbott Laboratories’s carotid stent met primary study goals for wider use, according to U.S. regulators weighing whether to expand the device’s approved use beyond patients who are too sick for surgery.
Clinical trials on the RX Acculink Carotid Stent “met the pre-specified criteria for study success,” Food and Drug Administration staff said in a preliminary review released today on the agency’s website. Outside advisers to the FDA will meet Jan. 26 to discuss the findings.
Abbott, based in Abbott Park, Illinois, is seeking to expand use of the device after a study last year concluded that carotid stents are as safe and effective as surgery. The FDA cleared its use in 2004 as an alternative treatment for patients at a high risk for complications from surgery to remove plaque from arteries that carry blood to the brain. Such blockages can lead to strokes if left untreated.
The advisory panel “will be asked to fully assess the significance” of the study findings, “and comment on the risk- to-benefit ratio,” the FDA staff said in today’s report.
Last year’s study, known as Crest and conducted in the U.S. and Canada, found that a stroke, heart attack or death occurred within 30 days in 4.5 percent of patients treated with Abbott’s stent, compared with 5.2 percent of surgery patients, researchers said. Strokes were more likely to occur in patients who received the stent, while heart attacks were more likely to occur in patients who had surgery, the study found.
Study Indicates Risks
The North American study, published in July in the New England Journal of Medicine, followed research in Europe that found carotid stenting to be riskier than surgery. Abbott’s Acculink competes with stents sold by Boston Scientific Corp., Johnson & Johnson, and Ev3 Inc.
The total U.S. market for carotid stents was about $70 million last year, Karene Dumoulin, an analyst with Millennium Research Group in Toronto, said Jan. 21 in an interview. The market may increase to $104 million in 2015 if the FDA approves the devices for more patients and Medicare coverage expands, she said.
About 795,000 people in the U.S. suffer a stroke each year, according to the Atlanta-based Centers for Disease Control and Prevention.
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