Natick, MA and San Francisco, CA -- Boston Scientific Corporation reports positive outcomes from the CABANA post-approval study of the  Carotid WALLSTENT^® Monorail^® Endoprosthesis used in conjunction with its FilterWire EZ™ Embolic Protection System in routine clinical practice.  Multi-center registry results demonstrate that carotid artery stenting (CAS) with Carotid WALLSTENT and FilterWire EZ is a safe alternative to carotid endarterectomy (CEA) in patients with carotid artery stenosis who are at increased risk for surgery.  The analysis was presented today by L. Nelson Hopkins, M.D., Chairman of Neurosurgery at the State University of New York in Buffalo, Trial Investigator and Advisory Committee member, at the Cardiovascular Research Foundation's annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in San Francisco.

The CABANA study enrolled 1,097 patients at 99 sites in the U.S.  Within the patient population, 32.7 percent were symptomatic and 67.3 percent were asymptomatic for carotid artery disease.  All patients were at high risk for CEA, the standard surgical treatment for carotid stenosis, due to pre-specified anatomical criteria and/or medical comorbidities.  The primary endpoint of 30-day composite rate of major adverse events (MAE), which included stroke, death and myocardial infarction (MI), was 4.6 percent.  The 30-day stroke rate was 3.3 percent, with the majority of strokes being ipsilateral (occurring on same side as blockage) and ischemic (resulting from lack of blood flow).  Overall mortality was 1.3 percent and the rate of MI was 0.5 percent at 30 days.  Technical success was achieved in 97.1 percent of patients.  Follow-up at 30 days included clinical evaluation and independent neurologic and National Institutes of Health (NIH) stroke scale assessments.

"Results from this post-approval study show low rates of stroke, death, and MI, demonstrating that the Carotid WALLSTENT and FilterWire EZ can be used in carotid stenting procedures as a safe alternative to surgery in high-risk patients," said Dr. Hopkins.  "In my clinical practice, I have found that the user-friendly design of this stenting system contributes to successful outcomes in patients with carotid artery stenosis at increased risk for surgery."

The Carotid WALLSTENT Monorail Endoprosthesis is a self-expanding stent with a closed-cell design to provide increased scaffolding for improved lesion coverage and a smooth inner lumen.  It features a highly flexible, low-profile stent delivery system designed to provide exceptional tracking through difficult anatomy.  The FilterWire EZ Embolic Protection System is designed to capture plaque debris that may be released during a procedure, preventing it from traveling to the brain, where it could cause a stroke.  The Carotid WALLSTENT Monorail Endoprosthesis is the leading carotid stent in Europe and is available in all major markets worldwide.    

"As public discussion continues regarding carotid stenosis therapy, the CABANA study demonstrates our commitment to providing physicians with safe and effective CAS treatment options supported by strong clinical evidence," said Jeff Mirviss, President of Boston Scientific's Peripheral Interventions business.  "The Carotid WALLSTENT and FilterWire EZ System offer a less-invasive alternative for treating carotid artery disease and can help reduce the risk of stroke, which can have devastating consequences on patients and their families."

The U.S. Food and Drug Administration (FDA) approved the Carotid WALLSTENT in 2008.  The FilterWire EZ Embolic Protection System received FDA clearance for use in carotid artery stenting procedures in 2006.  

About Carotid Artery Disease

The carotid arteries, located on either side of the neck, are the main conduit for blood supply to the brain.  Plaque formation in these arteries can lead to carotid artery disease, which puts patients at increased risk for stroke.  Patients with carotid artery disease are typically treated with carotid endarterectomy, a surgical procedure involving an incision in the neck and removal of plaque from the vessel walls.  Carotid artery stenting is a less-invasive alternative in which a stent is delivered to the blocked site and expanded, forcing open the artery walls and restoring adequate blood flow.  

Source: Boston Scientific Corporation