December 18, 2008 - Boston Scientific Corp. today announced enrollment of the first patient in the CABANA post-market approval study of the company’s Carotid WALLSTENT Monorail Endoprosthesis used in conjunction with its FilterWire EZ Embolic Protection System.
The first patient was enrolled in the CABANA Study by Rajesh M. Dave, M.D., chairman, endovascular medicine, Pinnacle Health Heart and Vascular Institute, Harrisburg Hospital, Harrisburg, PA.
The CABANA Study is a multi-center, U.S. surveillance registry designed to enroll a minimum of 1,000 patients at up to 150 sites. The objective of the study is to compile early clinical outcomes data for the Carotid WALLSTENT Monorail Endoprosthesis and FilterWire EZ Embolic Protection System in routine clinical practice. The FDA approved the Carotid WALLSTENT in October. The FilterWire EZ Embolic Protection System received FDA clearance for use in carotid artery stenting procedures in December 2006.
“We are pleased to be part of this study, which follows recent FDA approval of the Carotid WALLSTENT with the use of the FilterWire EZ Embolic Protection System,” said Christopher J. White, M.D., chairman, department of cardiovascular diseases, Ochsner Clinic Foundation, New Orleans, and principal investigator of the study. “We expect that the user-friendly design and ease of use will contribute to improved outcomes in patients with carotid artery stenosis who are at increased risk for carotid surgery.”
The Carotid WALLSTENT Monorail Endoprosthesis is a self-expanding stent with a closed-cell design to promote increased scaffolding for excellent 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 Endoprosthesis and Filter Wire EZ System is the only carotid artery stent system indicated in the United States for the treatment of certain patients at high risk for surgery with either ipsilateral or bilateral carotid artery disease (blockages in carotid arteries on one or both sides of the neck).
The BEACH Trial was a prospective, non-randomized, single-arm clinical trial with 480 patients, which demonstrated the safety and efficacy of the Carotid WALLSTENT Monorail Endoprosthesis and FilterWire EZ Embolic Protection System. These patients were considered high risk for carotid endarterectomy (CEA), the surgical treatment for carotid artery disease, because they had either anatomical issues (related to the anatomy of the neck, such as tight, tortuous vessels) or co-morbidity (multiple risk factors such as age, angina and heart failure). The primary endpoint in the BEACH trial was one-year morbidity and mortality defined as the cumulative incidence of non Q-wave myocardial infarction within 24 hours of the index procedure, peri-procedural (less than or equal to 30 days) death, stroke and Q-wave myocardial infarction and late ipsilateral stroke and neurological death from 31 days through 12-month follow-up. The one-year morbidity and mortality rate reported in the BEACH trial was 8.9 percent. The reported BEACH ipsilateral stroke rate (a stroke occurring on the treated side) was 3.3 percent, while the major ischemic stroke rate was 1.1 percent at 30 days.
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