FDA approves Boston Scientific's carotid artery stent
According to Boston Scientific, the CABANA study enrolled 1,097 patients at 99 sites in the United States. Within the patient population, 32.7% were symptomatic and 67.3% were asymptomatic for carotid artery disease. All patients were high risk for carotid endarterectomy because of prespecified anatomical criteria and/or medical comorbidities.
Carotid Wallstent Monorail Endoprosthesis
Trial investigator Nelson Hopkins said data from the post-approval study show low rates of stroke, death, and myocardial infarction, 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.
The multicentre CABANA post-approval study enrolled 1,097 patients and showed that carotid artery stenting with the carotid Wallstent and FilterWire EZ is a safe alternative to carotid endarterectomy in patients with carotid artery stenosis.
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The company stated that the multicenter registry results showed that carotid artery stenting with the Wallstent and FilterWire EZ is a safe alternative to carotid endarterectomy in patients with carotid artery stenosis who are at increased risk for surgery.
Endovascular Today - Buyer's Guide > Self-Expanding …
Boston Scientific advised that the carotid Wallstent Monorail endoprosthesis is a self-expanding stent with a closed-cell design, which provides increased scaffolding for improved lesion coverage and a smooth inner lumen. The device features a highly flexible, low-profile stent delivery system that is designed to track through difficult anatomy. The FilterWire EZ embolic protection system is designed to capture plaque debris that may be released during a procedure. The US Food and Drug Administration approved the device in 2008, and it is available in all major markets worldwide. The FilterWire EZ received US Food and Drug Administration clearance for use in carotid artery stenting procedures in 2006.
Iliac vein stenting is an extension of arterial stent technology
According to the manufacturer, this closed-cell low-profile device is designed to provide tracking through tortuous anatomy. The monorail delivery system allows rapid catheter exchanges. They say that the Carotid Wallstent is the only carotid stent indicated for use in high...
United States (English) - Boston Scientific- US
November 8, 2011—Boston Scientific Corporation (Natick, MA) announced positive outcomes from the postapproval study of the company’s carotid Wallstent Monorail endoprosthesis used in conjunction with its FilterWire EZ embolic protection system in routine clinical practice. L. Nelson Hopkins, MD, presented the analysis at the annual Transcatheter Cardiovascular Therapeutics scientific symposium in San Francisco.
Endoluminal Stent–Grafts for Infrarenal Abdominal Aortic Aneurysms
Boston Scientific’s carotid Wallstent Monorail endoprosthesis with FilterWire EZ Embolic protection system has been found to be safe for high surgical risk patients in routine clinical practice.