WALLSTENT™ Endoprosthesis - Boston Scientific

Ordering Information Carotid WALLSTENT Monorail Endoprosthesis UPN/Order Code Catalog No.

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Important Safety Information Thoracic Aortic Aneurysm (TAA) Overview. This therapy is not for everyone. Please consult your physician. MRI Safety and Compatibility.

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Boston Scientific Gets FDA Clearance for Carotid WALLSTENT

Age, sex, vascular risk factors, list of current medications, clinical and imaging data were collected for all patients. Stroke severity was assessed by the NIH Stroke Scale (NIHSS) at the following time points: before rtPA treatment, at the end of rtPA infusion, at 24 hours, at discharge, and 3 and 12 months after stroke onset. Severity of the stenosis was assessed by the NASCET criteria []. CAS was performed as soon as possible (but >24 hours) by an experienced team of interventional radiologists (EP, RG). No stent was placed within the first 24 hours after IV rtPA administration due to the absolute contraindication to start double antiplatelet treatment during this time frame. Prior to CAS procedure, ASA (100mg/day) and clopidogrel (75mg/day) were administered to all patients. During the procedure, intravenous heparin (5000IU) was administered. To prevent bradycardia and hypotension during balloon inflation and stent deployment, prophylactic atropine (0.5–1mg) was administered in all patients 1 minute before stent deployment. Following the CAS procedure, ASA (100mg/day) and clopidogrel (75mg/day) were administered to all patients during 6 weeks, later only ASA (100mg/day) was prescribed. All procedures were performed in an angiographic room; patients were assisted by an anaesthesiologist for invasive arterial pressure measurement and oximetry monitoring. The patients, under light sedation, were kept conscious. The procedure adopted in our institution has been previously described []. A single self-expandable stent was implanted to cover the entire lesion in all patients. The stent used was the Cristallo Ideale (Carotid Self-Expanding Stent System; Medtronic) and the WALLSTENT Monorail Endoprosthesis (Boston Scientific, US). Protection devices were the EPI Filter Wire EZ Embolic Protection System (Boston Scientific Corporation, USA) or The SPIDER Embolic Protection Device (ev3, Plymouth, MN). All stent were postdilated with noncompliant balloons (range 5-6mm). In all patients, after stent deployment, a postprocedural angiography was performed to evaluate the eventual residual stenosis and intracranial circulation.

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WALLSTENT™ Endoprosthesis 40412

In 2008, the Gore Viabahn received FDA indication foruse in iliac occlusive disease treatment. This indication wasobtained from data that were collected as part of theGore Viabahn Endoprosthesis Feasibility Study, which tookplace between 1996 and 1999 in the United States andEurope. Forty-five limbs in 42 subjects with Rutherfordcategory 3 or less and iliac arterial occlusive disease weretreated with the first-generation Viabahn endoprosthesis. Technical success was achieved in 100% of patients, withprocedural success in 93.2%. The primary outcome of12-month patency was 86.1%.7

WALLSTENT ® Colonic & Duodenal Endoprosthesis:

Both the balloon-expandable iCast and the self-expandingViabahn have an important role in treating occlusiveiliac artery disease. Balloon-expandable stents have classicallybeen the therapy of choice for aortoiliac bifurcationdisease, but evolving data suggest that the iCast could be asuitable alternative. The iCARUS trial will further definethe role of stent grafts in aortoiliac occlusive disease. TheViabahn endoprosthesis is the only currently availableFDA-approved covered stent for the iliac artery and is aviable alternative to self-expanding nitinol stents in theexternal iliac vessel. Future trials will provide additionaldata on appropriate patient selection, as well as the safetyand efficacy of these devices.