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The ultra-thin iCAST covered stent utilizes the latest developments in PTFE film lamination technology. Atrium’s Film-Cast Encapsulation Technology protects the 316L stainless steel struts from contacting the luminal wall and is designed to expand uniformly to prevent tissue from prolapsing through the expanded stent.
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We found at least 10 Websites Listing below when search with icast stent sizes on Search Engine
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Atrium iCAST™ Balloon expandable Covered Stent
atrium iCAST™ Balloon expandable Covered Stent. Atrium’s iCAST™ balloon expandable covered stent is FDA 510(k) cleared for the treatment of tracheobronchial strictures.. The iCAST covered stent provides deployment accuracy due to its precision stent delivery platform and its low foreshortening design. The iCAST stent is crafted using Atrium’s PTFE encapsulation technology and a one ...
DA: 17PA: 28MOZ Rank: 45
Mri Machine
Balloon-Expandable Covered Stents - Endovascular Today
Endovascular Today (ISSN 1551-1944 print and ISSN 2689-792X online) is a publication dedicated to bringing you comprehensive coverage of all the latest technology, techniques, and developments in the endovascular field.
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MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. ICAST ...
The icast was being used to intervene. The procedure could not be completed and when removing the undeployed icast stent from the body, it was noted that the stent was no longer on the balloon through fluoroscopy. It was determined that the stent was in the right internal iliac vein per the physician. The decision was made by the physician to ...
DA: 22PA: 39MOZ Rank: 61
ICast Covered Stent - 9mm x 38mm x 80cm - Medical Materials
Mri Safety List
iCast Covered Stent - 9mm x 38mm x 80cm Atrium Medical Was ... Current Stock: This item is out of stock. Please email or call us at 877-663-8686 and we will try to locate the product with our suppliers. Email Me When In Stock Add to Wish List. Create New Wish List ...
DA: 20PA: 50MOZ Rank: 74
Atrium iCast Covered Stent - bmctoday.net
sue. Atrium comments that iCast has the lowest crossing profile com-pared to other commercially available stents, providing for a more effi-cient delivery. For 5-mm to 10-mm sizes, iCast is 7-F compatible; the 12-mm version is 8-F compatible. Atrium iCast Covered Stent GE Healthcare (Milwaukee, WI) has launched the
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Covered Stents for Treating Aortoiliac Occlusive Disease ...
All iCast stents are 0.035-inch guidewire compatible and are mounted on a 5-F catheter shaft size with available lengths of 80 and 120 cm. Devices are compatible with either a 6- or 7-F introducer sheath. The iCast is currently approved for the treatment of tracheobronchial strictures.
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ICast Balloon Expandable Covered Stent | DAIC
A comparison of stent strut thickness between the Orsiro stent, pictured, and the market-leading stents on the U.S. and European markets. Vendors have been working toward reducing strut thickness to help improve overall clinical outcomes. Orsiro is now the smallest strut stent available on the market.
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Catalogue Numbers for GORE® VIABAHN® VBX Balloon ...
1. Secondary balloon required to post-dilate the stent beyond its nominal deployed diameter (secondary balloon not included). 2. Technical limit of the device. Expansion beyond 13 mm is outside of the indication − see Instructions For Use.
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Safety Information - AFX - Endologix
The artifacts that appeared on the MR images were shown as localized signal voids (i.e., signal loss) that were moderate in size relative to the size and shape of these implants. The gradient echo pulse sequence produced larger artifacts than the T1 -weighted, spin echo pulse sequence for the Endologix Stent Graft. MR imaging quality may be ...
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Download Icast Covered Stent Mri Safety For Machines
Class 2 Device Recall iCAST and Advanta
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated.
DA: 22PA: 34MOZ Rank: 56
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› Icast stent mri
TopCovered-stent Grafts
Self-expanding polyethylene terephthalate and polytetrafluoroethylene (PTFE)-covered stents have been shown to decrease the need for repeat procedures in the iliac artery.[33] Similar to surgical bypass, minimal luminal diameter may affect the patency of these stents.
The Gore Viabahn® endoprosthesis (originally marketed under the name Hemobahn®) and the Gore Viabahn endoprosthesis with heparin bioactive surface (WL Gore & Associates, AZ, USA) are FDA approved for use in patients with symptomatic iliac artery lesions, with reference vessel diameters ranging from 4.0 to 12 mm, and are also FDA approved for use in patients with symptomatic superficial femoral artery lesions with reference vessel diameters ranging from 4.0 to 7.5 mm. The Viabahn is a flexible, self-expanding endoluminal endoprosthesis, consisting of an expanded PTFE lining, with an external nitinol support extending along its entire length. The device is also available with a heparin bioactive surface, where the surface of the endoprosthesis is modified with covalently bound, bioactive heparin. The endoprosthesis is compressed and attached to a dual-lumen delivery catheter. The larger central catheter lumen is used for flushing and guidewire introduction. The smaller lumen contains elements of the deployment mechanism. The delivery catheter hub assembly has one port for the deployment system, and one port for flushing and guidewire insertion. To facilitate accurate endoprosthesis placement, two radiopaque metallic bands are attached to the catheter shaft, marking the ends of the compressed endoprosthesis. The device is available in 5–13 mm diameters, and the delivery sheath ranges from 7 to 12 Fr.
The most extensive prospective multicenter data on the Hemobahn endograft comes from a trial conducted in Europe and the USA, treating 61 iliac and 80 femoral arteries for superficial femoral artery occlusive disease between 1996 and 1998.[34] The purpose of this study was to investigate the safety and efficacy of the Hemobahn endograft. Clinical category status, ABI and color-flow duplex imaging results were recorded before treatment, at discharge, and 1, 3, 6 and 12 months after treatment. Clinical effectiveness was determined by using the chronic limb ischemia categories, proposed by the Society of Vascular Surgery and the International Society of Cardiovascular Surgery. Limb ischemia categories were scored from grade 0 for asymptomatic, to grade 6 for major tissue loss with a functional foot that can no longer be salvaged. Clinical effectiveness was defined as improvement by at least one clinical category level over the pretreatment level. Aspirin was administered throughout the study, and heparin was administered during, and 2 days after, the procedure. The Clinical Status Scale is a functional grading scale, from -3 (markedly worse), to 0 (baseline), to +3 (markedly better).
In 53 patients (61 limbs), an iliac arterial obstruction (stenosis or occlusion) was treated. The common iliac artery was treated in 32 limbs, and the external iliac artery was treated in 29 limbs. Complications occurred in ten iliac procedures, and included one major complication (infection). Early thrombosis (within 30 days) occurred in one iliac artery. Late restenosis or reocclusion was observed in five iliac arteries within the first year.
Mri Room Safety
The 1-year primary and secondary patency rates in this patient population, based on color-flow duplex ultrasound findings, were 91 and 95% in the iliac arteries. In the iliac group, the mean ABIs were 0.59 before treatment and 0.92, 0.91, 0.93 and 0.85 at 1, 3, 6 and 12 months after treatment, respectively. During follow-up, early occlusion of the prosthesis (within 30 days) occurred in one limb in the iliac-treatment group, and late occlusions (30 days–12 months) occurred in an additional five limbs in the iliac group. Pretreatment chronic limb ischemia categories for the 53 patients in the iliac arterial-treatment group were as follows: no patients with grade 0, five with grade 1, 22 with grade 2, 21 with grade 3, two with grade 4 and three with grade 5. At 1 year after treatment, chronic limb ischemia grades were reported for 46 patients in the iliac-treatment group as follows: 29 with grade 0 ischemia, seven with grade 1, seven with grade 2, three with grade 3, and none with grades 4–6. In addition, Clinical Status Scale scores at 1 year after treatment were reported for 44 patients in the iliac-treatment group: one patient showed a mild decline (score: 21), four showed no change or minimal improvement (score: 0 or 11), ten showed moderate improvement (score: 12) and 29 showed marked improvement (score: 13). The authors concluded that the Hemobahn endoprosthesis can be implanted without additional risks to the patient and provided encouraging patency rates up to 1 year.
Voyager Heart Stent
The Covered Balloon-Expandable Stent (COBEST) trial is a randomized, multicenter, prospective trial, being conducted in Australia, comparing Atrium's (Atrium Medical Corporation, NH, USA) proprietary balloon-expandable covered-stent technology (Advanta V12® covered stent; iCAST® in the USA) to bare-metal stents, commonly prescribed for iliac occlusive vessel disease.[35] The Advanta V12 covered stent is a low-profile premounted covered stent, made of a radial-expandable stainless steel stent, which is completely encapsulated with a patented microporous layer of expanded PTFE film.
The study randomized 167 limbs (123 patients) from 12 hospital centers across Australia. Patients were included if they had TransAtlantic Inter-Society Consensus (TASC) B, C or D iliac occlusive disease. A total of 83 limbs were randomized to the Atrium Advanta V12 covered-stent group, and 84 limbs were randomized to the bare-metal stent group. All patients were administered clopidogrel and aspirin postprocedurally. Patient characteristics were similar in all groups, except for a greater percentage of patients with hypertension in the bare-metal stent group, and a greater number of challenging TASC D lesions in the Atrium covered-stent group.
The primary objective of COBEST is to compare the outcome benefits of balloon-expandable covered-stent technology to the current standard of care with bare-metal stents. This clinical study comparison included binary restenosis (renarrowing of the vessel within the treated stent region), and freedom from stent occlusion (a complete blockage), primarily assessed through duplex ultrasonography up to 18 months. Secondary objectives included comparing amputation rates, noninvasive tests, including ABIs, and symptomatic patient outcomes, based on type-of-lesion classification (TASC B, C and D), target vessel revascularization, as well as patient relief at each time interval up to 18 months. The interim data represented 160 limbs with a full 12-month follow-up, with 132 limbs having reached the 18-month time frame. Of note, there were fewer patients with TASC D lesions in the bare-metal stent group (7%) compared with the covered-stent group (16.1%).
Mri Side Effects
The Atrium covered-stent group had significantly less binary restenosis than the bare-metal stent group (p < 0.0175), and greater freedom from stent occlusion compared with bare-metal stents (p < 0.0173). At 18 months, 95.4% of the covered-stent group were free of binary restenosis, compared with 82.2% for the bare-metal stent group. Of the covered-stent patients, 94.2% showed a clinical improvement at 18 months compared with 76.7% in the bare-metal stent group (p < 0.008). The covered-stent group also experienced a lower amputation rate (1.2 vs 3.6%) and a lower complication rate (4.8 vs 10.7%). No deaths were reported in the study.
Icast Stent Sizes
Analysis of the lesion classification showed superiority of the Advanta V12 covered stent in type C and D lesions over bare-metal stents. While no significant difference was observed in the overall patency rate of the randomized clinical trial in patients with type B lesions, the interim results of the COBEST trial demonstrated that there is a significant benefit when using the covered stent in type C and D lesions with regard to binary restenosis, freedom from occlusion and clinical improvement. Bare-metal stents in this clinical study experienced a fivefold increase in target lesion revascularization.