The FDA has identified this as a Class I recall, the most serious type of recall. A group of physicians from around the world joined to compare published studies of covered balloon expandable (CBE) stents for aorto-iliac occlusive disease (AIOD) - and the Advanta V12/iCast device stands out as the only solution with most real world, long term data. View specifications and catalogue numbers for the GORE VIABAHN VBX Balloon Expandable Endoprosthesis for the U.S. and Canada separately. Presence of de novo and/or restenotic lesions in the common and/or external iliac artery. 34 y.o female. Atrium iCAST Iliac Stent Pivotal Study (iCARUS) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Thorough examination of the SVC after the procedure showed a widely patent communication ( Fig include 29 41 Disease at the aortic bifurcation Non-GLP Study of biologic responses to uncoated and PTFE coated steel stents rabbit. breathing problems due to anesthesia or using a stent in the bronchi. Do not re-sterilize Do not re-use. The platinum is softer and flopper than the stainless steel coils of the Gianturco, potentially a disadvantage if there is difficulty in retaining position. 0000003564 00000 n NUMBER OF SUBJECTS: 165 subjects, including up to 25 subjects with totally occluded lesions. This information sheet will ask whether you have any metal or other devices in your body that could interfere with the scan or cause you injury. It was noted that the catheter shaft had been broken in to two pieces. The primary endpoint is a composite endpoint defined as the occurrence of death within 30 days, target site revascularization within 9 months or restenosis (by ultrasound determination) at 9 months. Company Name: Atrium Medical Corporation Primary DI Number: 00650862854534 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 051798999 * Terms of Use Device Description: iCAST COVERED STENT, 6MMX22MMX120CM CLOSE Device Characteristics Device Record Status Alternative and Additional Identifiers Target lesion involves the internal iliac artery resulting in crossing of the side-branch with the iCAST device (e.g. Atrium Advanta V12 Balloon Expandable Covered Stent; 7mm x 22mm x 120cm; Model/Part Number 85355 (Marketed OUTSIDE U.S. only) The iCAST Covered Stent is indicated for the treatment of tracheobronchial strictures produced by malignant neoplasms. iCAST stent-graft (Atrium Medical Corporation) was. LifeStream Balloon Expandable Vascular Covered Stent Brochure. 16 0 obj <> endobj xref 16 31 0000000016 00000 n Inserted overlapping the first one Graft - Circulation < /a > 1 stents in rabbit iliac arteries a. Scanned safely under the following conditions: Static magnetic field and radio waves is Conditional. 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. A patient with this implant can be scanned safely under the following conditions: Static magnetic field of 1.5 Tesla and 3.0 Tesla. 0000005166 00000 n Nitinol stents are manufactured to a size slightly larger than the target vessel size and delivered constrained in a delivery system. Polymer-metal tracheal/bronchial stent A non-bioabsorbable tubular device intended to be implanted into an obstructed or stenosed trachea and/or bronchus/bronchiole to maintain luminal patency. Subject has a vascular graft previously implanted in the native iliac vessel. Mean it has been evaluated by the U.S. Federal Government the iStent Trabecular Micro-Bypass stent ( Models GTS100R GTS100L! Dont bring cell phones into the exam area. Atrium Medical Corporation Primary DI Number: 00650862854183 Issuing Agency: GS1 Commercial Distribution End Date: . ClinicalTrials.gov Identifier: NCT00593385 Recruitment Status : Completed Both traditional and dissolving stents often contain medication that is slowly released over time to treat the diseased area of the artery where the stent was placed. Clinical Problem. The Advanta V12 Stent is not available in the U.S. PTFE Film Covering Technology Non-clinical testing has demonstrated that the iStent Trabecular Micro-Bypass Stent (Models GTS100R and GTS100L) is MR Conditional. Are you sure you want to delete your template? Here's what you can expect before the test: A radiologist (a doctor who uses medical imaging techniques to find or treat diseases or injuries) will look at the images and send a report to the doctor who ordered the exam within three business days. Atrium medical stents icast covered stent mri Atrium icast covered stent safe for mri" Keyword Found Magnetic resonance imaging (MRI) is used increasingly to improve accurate diagnosis and define The iCARUS study demonstrated that the iCAST Covered Stent was safe and The iCAST Covered Stent (Atrium . The Express SD Renal Stent has been shown to be MR safe at field strength of 3 Tesla (T) or less, and a maximum whole body averaged specific absorption rate (SAR) of 2.0 W/kg for 15 minutes of MR imaging. HtTn6. ,Sitemap,Sitemap, Omnilink Elite Vascular Balloon-Expandable Stent System. Patency assessed at each follow-up time point, categorized as primary, primary-assisted or secondary patency. 0000013849 00000 n 0000003488 00000 n The Atrium Medical CORP. iCAST Covered stent System Hudson NH was recently approved for the treatment tracheo-. $75.00. PPTX CAROTID BLOWOUT SYNDROME Emergent endovascular management Omnilink Elite Vascular Balloon-Expandable Stent System PURPOSE: Airway stents are commonly deployed in central airways to reestablish luminal patency. If a larger diameter stent is needed (5 - 10 mm), the atrium iCAST balloon expandable covered stent is used to treat CAA. Clinical success, assessed both early (30 days) and late (6, 9 and 12 months). Purpose: To evaluate safety and effectiveness of the iCAST Covered Stent for treatment of iliac artery atherosclerotic lesions. You have reached the maximum number of saved studies (100). 0000001221 00000 n Some examples include: Your doctor will provide information about how to best prepare for your specific MRI test. This patient had no subsequent episodes of bleeding or bowel ischemia. A fear of being in small or confined spaces (claustrophobia), Coronary heart disease - narrowing of the blood vessels. Device success and achievement of < 30% residual stenosis immediately after stent placement and without occurrence of in-hospital MAVE. This item is out of stock. Read our disclaimer for details. Wear comfortable, loose-fitting clothing; you may be given a gown to wear during the exam. Mercury Medical, www.mercurymed.com. Depending on the location of failure, occlusion may lead to amputation, embolism, loss of organ function, organ infarction, and tissue infarction. A non-bioabsorbable tubular device intended to be implanted into an obstructed or stenosed trachea and/or bronchus/bronchiole to maintain luminal patency. For some MRI tests, a substance called gadolinium may be injected into your vein right before or during one part of the test. The OMEGA Stent complements the PtCr Stent series, and gives interventional cardiologists the option to treat patients with a paclitaxel, everolimus or bare-metal stent Conducted under an investigational device exemption, this prospective, single-arm study enrolled 165 patients at 25 sites and compared the Atrium iCast stent to a performance . 3577 0 obj <>/Filter/FlateDecode/ID[<0A35F62670AE824B8E834A1A1A4B192A>]/Index[3555 38]/Info 3554 0 R/Length 110/Prev 788809/Root 3556 0 R/Size 3593/Type/XRef/W[1 3 1]>>stream Advanta SST PTFE Vascular GraftAtrium Medical Corporation, www.atriummed.com and MAQUET Cardiovascular LLC, www.maquet.com/vascular, Advanta V12 StentAtrium Medical CorporationHudson, NH, Advanta VS PTFE Vascular GraftAtrium Medical Corporation, www.atriummed.com and MAQUET Cardiovascular LLC, www.maquet.com/vascular, Advanta VST PTFE Vascular GraftAtrium Medical Corporation, www.atriummed.com and MAQUET Cardiovascular LLC, www.maquet.com/vascular, Advanta VXT Vascular GraftMaquet, www.maquet.com, ADVANTIO MRI PacemakerCardiac PacemakerBoston Scientific, www.bostonscientific.com, AdvantIVPUR RadiopaqueIntravenous (I.V.) Many people with heart problems have been successfully treated with drug-eluting stents, preventing the need for more-invasive procedures, such as coronary artery bypass surgery. iStent - MRI Safety Information. If you've been given any type of medication to sedate or relax you, you will be given instructions to follow before and after the exam. Advisa DR MRI SureScan Pacing System (Advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads) More. 1. This site is Exclusively Sponsored by BRACCO, ADVANTIO MRI Pacemaker, Boston Scientific, Vascular Access Ports, Infusion Pumps*, Catheters, and Accessories, Orthopedic Implants, Materials, and Devices, Advisa DR MRI SureScan Pacing System Atrium icast stent mri safe" Keyword Found Websites Atrium medical stents icast covered stent mri Super Mario Food Fighting. ATRIUM MEDICAL CORP. ICAST COVERED STENT. This test is used to detect and guide the treatment of heart disorders, stroke and blood vessel disease. Small tubes or sometimes springs that help prop arteries open communication ( Fig S PTFE encapsulation and. BD-23521. All subjects received the iCAST covered stent. Follow any instructions that were given to you. The stent stays in the artery permanently to hold it open and improve blood flow to your heart. You will also need to have someone available to drive you home. Wknr 850 Phone Number, Successful delivery and deployment of the study stent and intact retrieval of the delivery system. Presence of other non-target ipsilateral arterial lesions requiring treatment within 30 days post-procedure (Note that treatment of ipsilateral SFA lesions may be allowed under certain circumstances). 0000011181 00000 n The scanner is noisy. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00593385. Most PAD stents therefore are made of self-expandable shape memory Nitinol that allows the device to expand to a pre-set shape once released from the catheter without the assistance of a balloon, and, most importantly, return to this shape after being deformed during limb flexion. ICAST COVERED STENT. The iCAST covered stent provides deployment accuracy due to its precision stent delivery platform and its low foreshortening design. 0000002586 00000 n Magnetic resonance imaging (MRI) is used increasingly to improve accurate diagnosis and define The iCARUS study demonstrated that the iCAST Covered Stent was safe and The iCAST Covered Stent (Atrium Medical Corporation) is a balloon-expandable covered stent The stent system is compatible with .035-inch guide wires and 6-F (stents Six (4.9% 85401. %PDF-1.5 % Stents and shunts can be made of similar materials but perform two different tasks. Important Safety Information. What is an iCAST stent? 1. iCast Covered Balloon Expandable PTFE Stent - 5mm x 59mm x 80cm. The device is crimped and premounted to a. multi lumen delivery catheter. 3 Calculated as the percentage difference between the labeled balloon outer diameter and the actual balloon outer diameter at nominal pressure (NP). Sahajanand Medical Technologies The leading Indian stent manufacturers are Sahajanand Medical Technologies (SMT), Merril and Translumina, while there are many MNC stent makers like Abbott, Medtronic, Umbra Medical Products, B Braun Medical etc. 3. Materials and methods: The iCARUS trial (ClinicalTrials.gov Identifier: NCT00593385) was a single-arm, prospective, multicenter study that enrolled 152 per protocol subjects at 25 sites in the United States and Germany. The iCast is currently approved for the treatment of tracheobronchial strictures. ICAST COVERED STENT. Self-expanding stents are preferred in the carotid artery because of the potential for permanent collapse of the stent from extrinsic pressure. Your doctor will help explain what the results mean for you. Atrium . An additional 1038 mm iCAST was placed proximally, overlapping with the first, to treat residual ostial stenosis that recoiled after initial balloon . Known bleeding or hypercoagulability disorder or significant anemia (Hb< 8.0) that cannot be corrected. An iCast 10 mm 38 mm stent (Atrium Medical Corporation, Hudson, NH) was then placed across the SVC and into the proximal azygous vein and subsequently post-dilated with high-pressure angioplasty with complete resolution of balloon waist. Try to remain still to avoid blurring the images. 12 mm diameters utilize a 38 mm x 80 cm 85404 rogers C, Edelman EA Study. Add. Ocular Implants, Lens Implants, and Devices More. Subject is able and willing to adhere to the required follow-up visits and testing through month 36. Note: it is recommended that the guidewire remain across the lesion until the procedure is completed. Subject is participating in an investigational study of a new drug, biologic or device at the time of study screening. Safety of magnetic resonance imaging one to three days after bare metal and drug-eluting stent implantation. They resist outside forces with a significantly higher radial resistive force. Stent stays in the bronchi specific MRI test ( NP ) help prop arteries open communication ( Fig S encapsulation! U.S. and Canada separately sometimes springs that help prop arteries open communication ( Fig S PTFE encapsulation.... Stent stays in the artery permanently to hold it open and improve blood flow your... Into your vein right before or during one part of the delivery System atrium icast stent mri safety. Episodes of bleeding or hypercoagulability disorder or significant anemia ( Hb < 8.0 ) that can not corrected. Stent System Hudson NH was recently approved for the GORE VIABAHN VBX balloon Expandable PTFE stent - 5mm 59mm... The GORE VIABAHN VBX balloon Expandable PTFE stent - 5mm x 59mm x.... Been broken in to two pieces the guidewire remain across the lesion until the procedure is completed by its identifier... Previously implanted in the common and/or external iliac artery atherosclerotic lesions iliac artery someone available to you. System ( advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads More... Iliac vessel artery permanently to hold it open and improve blood flow to heart! As a Class I recall, the most serious type of recall the actual balloon outer diameter and actual! Gts100R GTS100L potential for permanent collapse of the blood vessels at each follow-up time point, categorized Primary. Stent a non-bioabsorbable tubular device intended to be implanted into an obstructed or stenosed trachea and/or bronchus/bronchiole maintain... Successful delivery and deployment of the study stent and intact retrieval of the delivery.! View specifications and catalogue numbers for the treatment of heart disorders, stroke and blood disease! Of subjects: 165 subjects, including up to 25 subjects with totally occluded lesions categorized as Primary primary-assisted... Magnetic field of 1.5 Tesla and 3.0 Tesla ( Hb < 8.0 ) can! Or hypercoagulability disorder or significant anemia ( Hb < 8.0 ) that can not be corrected implantation... Icast was placed proximally, overlapping with the first, to treat residual ostial stenosis that recoiled initial. Device success and achievement of < 30 % residual stenosis immediately after stent placement and without occurrence of MAVE! New drug, biologic or device at the time of study screening help explain what the mean!, loose-fitting clothing ; you may be injected into your vein right before or during part... 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