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.
The carotid Wallstent Monorail endoprosthesis is a self-expanding, flexible, low-profile stent delivery system designed to provide increased scaffolding for improved lesion coverage and a smooth inner lumen.
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.
In the study, the primary endpoints included stroke, death and myocardial infarction, of 4.6%.
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.
"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," Hopkins added.
The findings from the study were presented at the Cardiovascular Research Foundation's annual Transcatheter Cardiovascular Therapeutics scientific symposium in San Francisco, US.