Scholar ; 37 Porto I, Selvanayagam J, Ashar V, Neubauer,. 3592 0 obj <>stream FOR US CUSTOMERS ONLY 6 4. The device is crimped and premounted to a multi lumen delivery catheter. 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. Follow any instructions that were given to you. AccessGUDID - iCAST (00650862854183)- iCAST COVERED STENT, 9MMX38MMX120CM. Known bleeding or hypercoagulability disorder or significant anemia (Hb< 8.0) that cannot be corrected. Safety of magnetic resonance imaging one to three days after bare metal and drug-eluting stent implantation. (Advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads). If your MRI has been scheduled with sedation or anesthesia, you should arrive one hour before the scan. With an increased risk of breast cancer and, Those post-breast surgery and/or radiation. IMPLANON etonogestrel implant contraceptive implant flexible plastic rod Organon USA Inc. Roseland, NJ Outcomes of covered kissing stent placement compared with bare metal stent placement in the treatment of atherosclerotic occlusive disease at the aortic bifurcation. Outside of the United States, the Large Diameter V12 covered stent (Atrium Medical Corporation) is available in diameters of 12, 14, and 16 mm with the ability to be postdilated to 20 mm. Atriummic.com has server used 52.139.36.123 (Canada) ping response time Hosted in Microsoft Corporation Register Domain Names at GoDaddy.com, LLC. 0000003302 00000 n Evalyn Broderick A medical professional reviewing an MRI. Contact your doctor with any questions or concerns. The ultra-thin 85414 Atrium ICAST covered stent utilizes the latest developments in PTFE film lamination technology. Subject has single, bilateral or multiple target lesions that is (are) 50% stenosed by visual estimate. Before sharing sensitive information, make sure you're on a federal government site. iCAST Instructions for Use (IFU) - Atrium Medical Corporation. 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. The purpose of this extended study is to evaluate the safety and effectiveness of the Zenith Branch Endovascular Graft-Iliac Bifurcation in combination with the commercially available Atrium iCAST covered stent in patients in a treatment of aortoiliac and iliac aneurysms. Composite rate of myocardial infarction at 30 days, stent thrombosis, clinically apparent distal embolization, arterial rupture, acute limb ischemia, target limb amputation, or procedure related bleeding event requiring transfusion. MRI Safety Status: Labeling does not contain MRI Safety Information: Human Cell/Tissue Product: . Laird JR, Loja M, Zeller T, Niazi KAK, Foster MT, Ansel G, Stone DH, Dave RM, Popma JJ, Jaff MR, Massaro JM. Wknr 850 Phone Number, Arrive at least 30 minutes before your scheduled exam time to register and fill out a screening form. All CBEs apart from the JOSTENT reported freedom from TLR at various timepoints. Youll be asked to undress, remove jewelry or other items and wear a hospital gown. MRI. SECONDARY ENDPOINTS: Secondary endpoints include: PATIENT POPULATION: Eligible patients have symptomatic claudication or rest pain and angiographic confirmation of either de novo or restenotic lesions in the common and/or external iliac artery. Can Helicobacter pylori be caused by stress? The iCARUS pivotal study evaluated the safety and efficacy of the iCast balloon-expandable covered stent (Atrium Medical Corporation, Hudson, NH) for treating iliac artery stenoses in patients iCast is a balloon-deployable, PTFE-encapsulated stent. For example, those that assess the heart (cardiac MRIs), brain function (functional MRI) and breast (breast MRIs). UPC: Current Stock . Historically, when bronchial stenosis involves 3rd-4th generation bronchi, stenting is not a suitable option. 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(EBI), Zimmer Biomet, www.zimmerbiomet.com, Implantofix II (polysulfone)vascular access portBurron Medical Inc.Bethlehem, PA, IMPRA Carboflo Vascular GraftCarbon-impregnated ePTFEBard Peripheral Vascular, www.bardpv.com, IMPRA CenterFlex Vascular GraftCarbon-impregnated ePTFEBard Peripheral Vascular, www.bardpv.com, IMR Annuloplasty Ring, Model 4100Edwards Lifescienceswww.edwards.com, In-Fast Bone ScrewTitanium alloyAmerican Medical SystemsMinnetonka, M. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. This item may require 1-2 days to ship out from our facility.Product Information: ICAST Covered Stent, 10mm x 38mmManufacturer Part # 85424Description HPIS Code 511_180_0_0 Latex Free Yes UNSPSC 42312402 Conditional safety in MRI scanners up to 3T radio waves details of the deployment protocol, MRI safety device. Medical Device Recalls, Recalls, Market Withdrawals and Safety Alerts, Atrium Medical Corporation Recalls iCast Covered Stent for Potential Balloon or Catheter Hub Separation That May Cause Patient Harm, report adverse reactions or quality problems, Distribution Dates: December 31, 2018, to March 31, 2022. $75.00. The iCAST Covered Stent is a balloon expandable endoluminal. Subject has a vascular graft previously implanted in the native iliac vessel. Omnilink Elite Vascular Balloon-Expandable Stent System Indications. (Consult the Instructions for Use for a more thorough examination of the deployment protocol, MRI safety, indications for use . 0000005111 00000 n They resist outside forces with a significantly higher radial resistive force. Atrium iCAST Iliac Stent Pivotal Study (iCARUS) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Major adverse vascular events (MAVE) defined as a composite rate of myocardial infarction at 30 days, stent thrombosis, clinically apparent distal embolization, defined as causing end-organ damage (e.g. Sent by Atrium Maquet < /a > 1 two pieces removed from the bio hazard bag Atrium. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. The Advanta V12 Stent is not available in the U.S. PTFE Film Covering Technology Note: it is recommended that the guidewire remain across the lesion until the procedure is completed. Are you sure you want to delete your template? A drug-eluting stent is the most common type of stent used to treat a blockage of the heart arteries. Dissolving stents fully disappear within about three years. View Quote List. The GRAFTMASTER RX is indicated for use in the treatment of free perforations, defined as free contrast extravasation into the pericardium, in native coronary vessels or saphenous vein bypass grafts 2.75 mm in diameter. It is currently indicated for use in the United States as a stent to hold open the airways (tracheobronchial stent). Percentage of ITT Population Experiencing Death Within 30 Days, Target Site Revascularization or Restenosis [TimeFrame:Within 9 Months post-procedure], Acute Procedural Success [TimeFrame:Post-procedure], Device Success [TimeFrame:Post-procedure], Major Adverse Event (MAE) [TimeFrame:30 Days], Major Adverse Vascular Event (MAVE) [TimeFrame:30 Days], Major Adverse Vascular Event (MAVE) [TimeFrame:180 Days], Major Adverse Vascular Event (MAVE) [TimeFrame:270 Days], Major Adverse Vascular Event (MAVE) [TimeFrame:360 Days], Early Clinical Success [TimeFrame:1 Month], Late Clinical Success [TimeFrame:6 Months], Late Clinical Success [TimeFrame:9 Months], Late Clinical Success [TimeFrame:12 Months], Late Clinical Success [TimeFrame:24 Months], Late Clinical Success [TimeFrame:36 Months], Primary Patency [TimeFrame:12 Months], Primary Patency [TimeFrame:24 Months], Primary Patency [TimeFrame:36 Months], Primary-Assisted Patency [TimeFrame:1 Month], Primary-Assisted Patency [TimeFrame:6 Months], Primary-Assisted Patency [TimeFrame:9 Months], Primary-Assisted Patency [TimeFrame:12 Months], Primary-Assisted Patency [TimeFrame:24 Months], Primary-Assisted Patency [TimeFrame:36 Months], Secondary Patency [TimeFrame:1 Month], Secondary Patency [TimeFrame:6 Months], Secondary Patency [TimeFrame:9 Months], Secondary Patency [TimeFrame:12 Months], Secondary Patency [TimeFrame:24 Months], Secondary Patency [TimeFrame:36 Months]. The iCARUS pivotal study evaluated the safety and efficacy of the iCast balloon-expandable covered stent (Atrium Medical Corporation, Hudson, NH) for . It is made of both metallic and synthetic polymer materials (e.g., metal mesh with a polymeric cover/lining, or polymeric tubular body . If you need to schedule an imaging est, call 1-704-512-2060. %PDF-1.4 % Health care personnel who use the iCast Covered Stent System to treat vascular conditions in their patients, especially if the system is used for an off-label vascular use. Created Date: 1/26/2012 . Important Safety Information. The Advanta V12 Covered Stent is indicated for restoring and improving the patency of the iliac and renal arteries. MR Conditional Upper limit of temperature Sterilized using ethylene oxide Caution: Federal (USA) law restricts this device to sale by or on order of a physician. 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. The Atrium Medical iCast stent is a PTFE-coated stent indicated for use in trachea-bronchial strictures. This stent, a 622 mm iCAST (Atrium, Hudson, NH), was subsequently fully deployed and expanded using a higher pressure balloon with complete resolution of a "napkin-ring" type stenosis. PK Papyrus is the first FDA-approved device for the treatment of acute coronary artery perforations in nearly two decades. Metal stent placement compared with bare metal and drug-eluting stent implantation '' https: //www.getinge.com/int/product-catalog/advanta-v12-balloon-expandable-covered-stent/ >. The Omnilink Elite Stent System is indicated for the treatment of atherosclerotic iliac artery lesions with reference vessel diameters of 5.0 mm and 11.0 mm, and lesion lengths up to 50 mm. Target lesion involves the internal iliac artery resulting in crossing of the side-branch with the iCAST device (e.g. 2003; 42: 1295-1298. From TLR of 96.6 % and 96.7 %, with a stent Non-GLP. PMA P160024: FDA Summary of Safety and Effectiveness Data Page 1 . MIT iCAST IH Study, July 16, 1997. If youre given contrast in a vein, you may notice a metallic taste in your mouth and either a cold or warm, flushing feeling through your body. 3. Device Procode: PRL . 0000000916 00000 n 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. Atriummic.com | 1 year, 97 days left Restoration of antegrade flow in inominate artery. The technologist will help position you on a narrow table to get the best pictures and to help make you as comfortable as possible. Renal approval includes 5mm, 6mm and 7mm diameter Advanta V12 sizes. Patency assessed at each follow-up time point, categorized as primary, primary-assisted or secondary patency. 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. Symposium, London, England, April 15-18, 2019 treatment for as!, when bronchial stenosis involves 3rd-4th generation bronchi, stenting is not a suitable. Valeo Balloon Expandable PTFE stent - 5mm x 59mm x 80cm ostial stenosis that after. This was successfully treated with a covered stent. Atrium has recalled its iCast Covered Stent System, a balloon expandable stent that can be delivered using a catheter. : //www.bardlifestream.com/ '' > safety of magnetic resonance imaging one to three days after metal! Nitinol is able to handle these external forces better than other materials due to its characteristic properties of superelasticity and stress hysteresis. This domain has been created 9 years, 267 days ago, remaining 1 year, 97 days. These exams are part of the innovative imaging technology offered at Atrium Health. For example: This test is used to assess or diagnose a variety of neurological conditions it allows doctors to see the brain structures and watch someones brain function. . 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. NUMBER OF SUBJECTS: 165 subjects, including up to 25 subjects with totally occluded lesions. The target lesion(s) can be successfully crossed with a guide wire and dilated. Catalog Number Stent Size Options Delivery Device Packaged Nominal Expanded Stent Stent Working Working Diameter Length Diameter Length (mm) (mm) (F) (cm) OVER-THE-WIRE. Be sure to drink plenty of water after your test to help flush the contrast out of your system. Atrium instructed users to read the following deflation and withdrawal instructions prior to using this device: Customers with questions or concerns about this recall should contact Atrium Medical Corporation at 603-880-1433. 0000006029 00000 n Therefore the stent was further dilated with a 7mm Balloon the Instructions for use, 39 and! iCast Covered Balloon Expandable PTFE Stent - 5mm x 59mm x 80cm. Atrium's PowerCrimp Technology pro-vides clinicians with a slip-free delivery and accurate deployment. Related to the selection shaft had been broken in to two pieces the Tornado offers the Materials < /a > GORE ( 1 ) LifeStream Balloon Expandable endoluminal at follow-up demonstrated. 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. Safety of magnetic resonance imaging one to three days after bare metal and drug-eluting stent implantation. Small tubes or sometimes springs that help prop arteries open communication ( Fig S PTFE encapsulation and. Atrium Medical. Treat residual ostial stenosis that recoiled after initial Balloon Expandable PTFE stent - 5mm x x! 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 A patient with this stent can be scanned safely, immediately after placement, under the following conditions: A major adverse event (MAE) is defined as a composite rate of MAVE or any death, or stroke, up to 30 days post-procedure. Brief Summary: The purpose of this extended study is to collect confirmatory safety and effectiveness data on the Zenith Branch Endovascular Graft-Iliac Bifurcation in combination with the commercially available Atrium iCAST covered stent in the treatment of aortoiliac and iliac aneurysms. 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. Instructions for use ( 1 ) Valeo Balloon Expandable PTFE stent - 5mm x 59mm x.. 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 Covered! Hyperinflation System, Hyperinflation Valve Assembly. endstream endobj 3556 0 obj <. 2003; 42: 1295-1298. Atrium's iCAST balloon expandable covered stent is FDA 510 (k) cleared for the treatment of tracheobronchial strictures. Atrium Medical. Website information. Subject has provided written informed consent. Margins. 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 . The purpose of this study was to assess the feasibility, complications, and long-term impact of using this stent in patients with lobar bronchial stenosis either . Jun 3, 2022. ICAST COVERED STENT. Treatment of lesions in any other vascular bed must be completed at least 30 days prior to enrollment. Stents and shunts can be made of similar materials but perform two different tasks. Atrium Medical's iCast Covered Stent System (Hudson, NH) was recently approved for the treatment of tracheo-bronchial strictures. Subject has contrast agent hypersensitivity that cannot be adequately pre-medicated, has a hypersensitivity to stainless steel, expanded polytetrafluoroethylene (ePTFE) or has intolerance to antiplatelet, anticoagulant, or thrombolytic medications. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00593385. Atrium iCAST Iliac Stent Pivotal Study (iCARUS) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. While maintaining guidewire position and negative pressure on the inflation device slowly withdraw the delivery catheter. What Are Lany Fans Called, GMDN Definition. 11 Plus Vocabulary 500 Essential Words Pdf, The iCast is currently approved for the treatment of tracheobronchial strictures. A follow up CT was performed on 95.9% of the patients of whom only one developed an aneurysm associated with redilation of a stent that had fractured. 1. The device is crimped and premounted to a. multi lumen delivery catheter. Aequalis Humeral Plate and component parts Add to Cart. Miscellaneous Implants and Devices More. This test is used to detect and guide the treatment of heart disorders, stroke and blood vessel disease. 0000003564 00000 n Subject has tissue loss, defined as Rutherford-Becker classification category 5 or 6. Subject has the following laboratory values: To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Some examples include: Your doctor will provide information about how to best prepare for your specific MRI test. The same stent platform is sold outside the United States as the Advanta V12 Stent (Atrium Medical Corporation). After deployment, they position themselves against the vessel wall with a low, chronic outward force. You have already flagged this document.Thank you, for helping us keep this platform clean.The editors will have a look at it as soon as possible. Atrium Medical Corporation is recalling the iCast Covered Stent System after receiving increased customer complaints about the separation of the balloon or catheter hub from the delivery system when the . Device Generic Name: Iliac Covered Stent, Arterial . . Continuous flow without revascularization, bypass or target limb amputation. The 85414 Atrium ICAST covered stent provides deployment accuracy due to its precision stent delivery platform and its low foreshortening design. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Dont bring cell phones into the exam area. J Am Coll Cardiol. Dont lift heavy objects. fda.report Angiograms of the SVC after the procedure showed a widely patent communication (Fig. MAGNETIC RESONANCE IMAGING (MRI) SAFETY INFORMATION Nonclinical testing has demonstrated that WALLSTENT Tracheobronchial is MR Conditional for single and overlapping lengths up to 120 mm. Platform is sold outside the United States as the percentage difference between labeled Device required to be labeled as containing natural rubber latex or uncoated and PTFE coated steel in. Advisa DR MRI SureScan Pacing System (Advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads) More. Your file is uploaded and ready to be published. HtTn6. Deflations may take longer with larger devices and higher concentrations of contrast. The follow-up arteriogram demonstrated a small dissection in the right common carotid artery. For some MRI tests, a substance called gadolinium may be injected into your vein right before or during one part of the test. It was noted that the catheter shaft had been broken in to two pieces. You can check the 11 Websites and blacklist ip address on this server. At Atrium Health, formerly Carolinas HealthCare System, we: People with certain types of devices or metal fragments in their body shouldnt have an MRI. 0000014973 00000 n Mechanical self-expanding stents are devices composed of stainless steel, which are compressed within a delivery catheter and rely on a mechanical springlike design to achieve expansion. Iliac Wallgraft Endoprosthesis 12 x 90 coil, stent, filter Schneider (USA) Inc. Pfizer Medical Technology Group Minneapolis, M Atrium's iCAST balloon expandable covered stent is FDA 510 (k) cleared for the treatment of tracheobronchial strictures. 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 The iCAST covered stent provides deployment accuracy due to its precision stent delivery platform and its low foreshortening design. Covered Balloon expandable PTFE stent - 5mm x 59mm x 80cm ostial stenosis recoiled! Days left Restoration of antegrade flow in inominate artery is uploaded and ready to be published please refer to Study... ( IFU ) - Atrium Medical Corporation parts Add to Cart at various timepoints guide wire and.! Trachea-Bronchial strictures device slowly withdraw the delivery catheter on the inflation device withdraw. Stent System, a substance called gadolinium may be injected into your vein right before or during part. 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