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Boston Scientific Carotid WALLSTENT® Found Safe in Study of High Surgical Risk Patients in Routine Clinical Practice
Date:11/8/2011

NATICK, Mass. and SAN FRANCISCO, Nov. 8, 2011 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) 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 Instit
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