FDA approves Abbott's RX ACCULINK Carotid Stent System

Abbott (NYSE: ABT) today announced that the U.S. Food and Drug Administration (FDA) approved the RX ACCULINK® Carotid Stent System for the treatment of patients with carotid artery disease who are at standard risk of adverse events from carotid endarterectomy (surgery). RX ACCULINK was previously indicated for patients at high risk of adverse events from surgery. This expanded indication is supported by the results of the CREST (Carotid Revascularization Endarterectomy vs. Stenting Trial) study. RX ACCULINK, used with the RX ACCUNET® Embolic Protection System, represents an important option for standard-risk patients for the treatment of carotid artery disease.

"The CREST data demonstrated that carotid artery stenting is a safe, effective and minimally invasive treatment for standard-risk patients with carotid artery disease," said L. N. Hopkins, M.D., Professor and Chairman, Department of Neurosurgery, and Professor of Radiology, State University of New York at Buffalo. "With this broader indication, the RX ACCULINK Carotid Stent System will become an important option for physicians as they determine the most appropriate treatment approach for their patients."

As part of its submission for an expanded indication, Abbott submitted the results of the CREST study, which is the largest prospective study conducted to date comparing carotid artery stenting to surgery. CREST was sponsored by the National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health (NIH), and was partially funded by Abbott. The trial demonstrated that carotid artery stenting and carotid surgery had similar safety and long-term outcomes for standard-risk patients with symptomatic and asymptomatic carotid artery disease.

"FDA approval of the RX ACCULINK Carotid Stent System for patients at standard risk of surgery has the potential to significantly impact the treatment of patients with carotid artery disease," said Charles A. Simonton, M.D., FACC, FSCAI, divisional vice president, Medical Affairs, and chief medical officer, Abbott Vascular. "More than 60 percent of U.S. patients with carotid artery disease are at standard surgical risk, many of whom require a procedure to open the narrowed arteries that lead to the brain. This expanded indication for Abbott's RX ACCULINK provides these patients with an additional treatment option."

Abbott intends to seek expanded Medicare coverage for carotid stenting based on the CREST trial results. In addition, the company plans to initiate a post-approval study of the RX ACCULINK Carotid Stent System in patients at standard surgical risk later this year. The study is planned to assess clinical outcomes at 30 days and annually for three years.