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The New England Journal of Medicine Publishes Results of Landmark CREST Study, Showing Similar Positive Outcomes for Abbott's Carotid Stent System and Surgery
Date:5/26/2010

ABBOTT PARK, Ill., May 26 /PRNewswire-FirstCall/ -- Data from the CREST (Carotid Revascularization Endarterectomy vs. Stenting Trial) study were published today in The New England Journal of Medicine. In this trial, stenting and surgery had similar initial safety and longer-term outcomes for symptomatic and asymptomatic men and women. Adverse event rates of death, stroke and heart attack were also similar for both therapies. Abbott's ACCULINK® Carotid Stent System and ACCUNET® Embolic Protection System were used in the study, which was sponsored by the National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health (NIH), and partially funded by Abbott.

"As the worldwide market leader in the interventional treatment of carotid artery disease, we are proud of our long-standing commitment to expanding treatment options for patients and to advancing clinical evidence in the field, including our support of the landmark CREST study," said Robert Hance, senior vice president, vascular, Abbott. "Based on the strength of the CREST data, we plan to file an application in the U.S. by the end of this year seeking an expanded indication for the ACCULINK Carotid Stent System to treat patients with carotid artery disease who are at standard risk for surgery."

All carotid stent systems in the United States are currently indicated only for patients who are considered to be at high risk for surgical treatment due to anatomical factors, age or other considerations. The majority of patients with carotid artery disease are not part of this high-risk group, and therefore are not within the current U.S. Food and Drug Administration (FDA) indications for carotid stenting.

Abbott will submit the results of a pre-agreed-upon
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