Abbott receives FDA approval to expand use of the RX ACCULINK® Carotid Stent System

Abbott 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.

About RX ACCULINK Carotid Stent System

The RX ACCULINK Carotid Stent System, used in conjunction with the RX ACCUNET Embolic Protection System, is indicated for the treatment of patients at high risk and standard risk of adverse events from carotid endarterectomy who require carotid revascularization (a procedure to restore blood flow) and meet certain criteria. Additional information about the RX ACCULINK Carotid Stent System, including important safety information, is available online at www.abbottvascular.com/static/cms_workspace/pdf/ifu/carotid_intervention/RX_Acculink_Carotid_Stent_System.pdf.

About Stroke and Carotid Artery Disease

Stroke is the third leading cause of death in the U.S. and the number one cause of disability in adults, according to the American Heart Association. An ischemic stroke, the most common type, can occur when the carotid artery becomes narrowed and when small particles of atherosclerotic plaque become dislodged from the diseased artery wall. This embolic material can travel through the bloodstream and block blood vessels in the brain. More than 795,000 Americans will have new (610,000) or recurrent (185,000) strokes each year. On average, every four minutes someone in the U.S. dies of stroke.1

Carotid artery disease is the leading cause of stroke in the U.S., with more than 60 percent of all stroke occurrences known to be linked to carotid artery disease.2 Carotid artery disease involves the buildup of plaque in one or both carotid arteries in the neck. The carotid arteries supply oxygen and blood to the parts of the brain where thinking, speech, personality, and sensory and motor functions reside.

Patients with carotid artery disease have three treatment options: carotid artery stenting, carotid surgery (known as carotid endarterectomy) or medical therapy. The traditional surgical treatment for carotid artery disease usually requires general anesthesia and involves an incision in the patient’s neck and artery to remove plaque from inside the vessel wall. In contrast, during a carotid stenting procedure, an embolic protection system is positioned in the carotid artery and a stent is deployed using a catheter inserted into a small puncture in the patient’s groin. The patient usually remains conscious while the stent is implanted at the site of the blockage. The embolic protection system is designed to capture particles of plaque that might be dislodged during the procedure, which could potentially lead to stroke and other complications.

About Abbott Vascular

Abbott Vascular is a global leader in cardiac and vascular care with market-leading products and an industry-leading pipeline. Abbott Vascular offers a comprehensive cardiac and vascular devices portfolio, including products for coronary artery disease, vessel closure, endovascular disease, and structural heart disease.

References

1. Circulation “Heart Disease and Stroke Statistics 2010 Update. A Report from the American Heart Association.” January 26, 2010
2. New Technology Brief “Carotid Stenting”. A Report from the Health Care Advisory Board. 2006