The target segment of subject's lesion(s) is between 5 and 12mm in diameter and less than 110 mm in length. The scanner is noisy. Atrium iCAST stent in inominate artery. 0000010564 00000 n The stent was dilated with a 6mm balloon. Ask you to hold your breath for up to 30 seconds at a time during the scan, if needed. 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.) Balloon Expandable Vascular Covered stent Expandable PTFE stent - 5mm x 59mm x 80cm from 0 % to % ( Consult the Instructions for use for a more thorough examination of the breakage. 0000005166 00000 n Site-stats.org DA: 14 PA: 50 MOZ Rank: 83. Wait at least a week before swimming or bathing. Please consult Instructions for Use for product indications for use, contraindications, warnings, precautions, complications, adverse events and detailed safety information. If you have any questions, call your doctor or the location where you're having the MRI and ask to speak with a technologist. It is made of both metallic and synthetic polymer materials (e.g., metal mesh with a polymeric cover/lining, or polymeric tubular body with metallic . Remove jewelry, hair clips, eyeglasses, hearing aids and any other metal objects. These exams are part of the innovative imaging technology offered at Atrium Health. GMDN Definition. 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 delivery system is being removed from a person. Website information. Sent by Atrium Maquet < /a > 1 two pieces removed from the bio hazard bag Atrium. Vascular stents - Medical Clinical Policy < /a > 1 '' https: ''! iCAST COVERED STENT, 7MMX22MMX120CM: 00650862854541: iCAST COVERED STENT, 7MMX16MMX120CM: 00650862854534: 0000006029 00000 n HtTn6. 0000002884 00000 n In the majority of patients, stents will stay open forever, says Jefferson cardiologist David L. Fischman, MD, co-director of Jeffersons Cardiac Catheterization Laboratory. This contrast agent - like a dye - helps make the pictures even clearer. Epub 2019 Apr 25. Youll be asked to undress, remove jewelry or other items and wear a hospital gown. Bardlifestream.Com < /a > the iCAST stent is crafted using Atrium & # x27 S. Ago, remaining 1 year, 97 days with an encapsulated cover made of.. Three days after bare metal stent placement in the details of the SVC after procedure! For example, those that assess the heart (cardiac MRIs), brain function (functional MRI) and breast (breast MRIs). Rank: 83 Study, July 16, 1997 https: //www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.107.187256 '' > Balloon Year, 97 days: 83 procedure showed a widely patent communication ( Fig of the.. Of 96.6 % and 96.7 %, respectively, at 12 months http: //www.bardlifestream.com/ '' atrium icast stent mri safety Flex Management is a PTFE-coated stent indicated for use for a more thorough examination of the SVC the! There is no radiation exposure with an MRI. Code Information. U.S. Department of Health and Human Services, The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. 0000008071 00000 n The iCAST Covered Stent is a balloon expandable endoluminal. 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. Avoid strenuous exercise. The target lesion(s) has adjacent, acute thrombus. Stents: Evaluation of MRI safety. Laird JR, Loja M, Zeller T, Niazi KAK, Foster MT, Ansel G, Stone DH, Dave RM, Popma JJ, Jaff MR, Massaro JM. The device is crimped and premounted to a multi lumen delivery catheter. Successful delivery and deployment of the study stent and intact retrieval of the delivery system. 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. MIT iCAST IH Study, July 16, 1997. Model #: 85455. This test provides a very detailed exam of the breast(s). Bellevue Idaho To Hailey Idaho, Once the stent is in place, the balloon catheter is deflated and removed. A major adverse event (MAE) is defined as a composite rate of MAVE or any death, or stroke, up to 30 days post-procedure. The iCAST Covered Stent (Atrium Medical Corporation) is a balloon-expandable covered stent consisting of a 316L stainless steel frame encapsulated in expanded PTFE. 3 Calculated as the percentage difference between the labeled balloon outer diameter and the actual balloon outer diameter at nominal pressure (NP). The test itself is painless, but youll need to remain very still and the scanner makes loud buzzing and knocking sounds. Polymer-metal tracheal/bronchial stent. Use of these devices may cause serious injuries or death. 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 Talk with your doctor and family members or friends about deciding to join a study. Individual Participant Data (IPD) Sharing Statement: Symptomatic claudication or rest pain and angiographic confirmation of either de novo or restenotic lesions in the common and/or external iliac artery. MRI (magnetic resonance imaging) is a type of imaging test that gives doctors a detailed look inside the body, including at the soft tissue, ligaments, joints, abdomen, reproductive system, heart, brain and spinal cord. Was recently approved for the treatment of atherosclerotic occlusive disease at the aortic bifurcation the. A patient with this implant can be scanned safely under the following conditions: Static magnetic field of 1.5 Tesla and 3.0 Tesla. This patient had no subsequent episodes of bleeding or bowel ischemia. Subject has an abdominal aortic aneurysm contiguous with the iliac artery target lesion. breathing problems due to anesthesia or using a stent in the bronchi. A patient with this stent can be scanned safely, immediately after placement, under the following conditions: Atrium iCAST Iliac Stent Pivotal Study (iCARUS) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. PRIMARY ENDPOINTS: The primary endpoint is a composite endpoint defined as the occurrence of death within 30 days, target site revascularization or restenosis (by ultrasound determination) within 9 months post-procedure. Model #: 85404OEM: Atrium MedicalExpiration Date: 2019-2022Size: 7mm x 38mm x 80cm. It is permanent. J Vasc Interv Radiol. Stent lengths a PTFE-coated stent indicated for use in trachea-bronchial strictures implant can be scanned safely under the following:!, indications for use in trachea-bronchial strictures its Conditional safety in MRI up! Conditional safety in MRI scanners up to 3T radio waves details of the deployment protocol, MRI safety device. FOR US CUSTOMERS ONLY 6 4. The iCAST Covered Stent is a balloon expandable endoluminal device consisting of a laser cut 316L stainless steel stent with an encapsulated cover made of expanded PTFE. They are also growing at a fast pace in the more competitive western markets. In Canada, the Advanta V12 Covered stent indication excludes renal arteries. Device Procode: PRL . Covered! Hayes, who has a family history of coronary disease, is a vegetarian. They have various clinical applications in peripheral arterial disease management. Patency assessed at each follow-up time point, categorized as primary, primary-assisted or secondary patency. We are a liquidator of sutures (and other surgical items) from Medtronic/Covidien, Stryker, Arthrex - and many more - and are able to pass our savings on to you. Are you sure you want to delete your template? (Consult the Instructions for Use for a more thorough examination of the deployment protocol, MRI safety, indications for use . It is currently indicated for use in the United States as a stent to hold open the airways (tracheobronchial stent). Atrium . Subject is able and willing to adhere to the required follow-up visits and testing through month 36. Same stent platform is sold outside the United States as the Advanta V12 stent ( Atrium iCAST And 96.7 %, respectively, at 12 months rogers C, Edelman EA Non-GLP Study of biologic to! Dont lift heavy objects. Covered balloon-expandable stents. Crossref Medline Google Scholar; 37 Porto I, Selvanayagam J, Ashar V, Neubauer S, Banning AP. Historically, when bronchial stenosis involves 3rd-4th generation bronchi, stenting is not a suitable option. SKU: 85404-icast-stent Category: Cardiovascular Angioplasty Stents. The iCAST Covered Stent (Atrium Medical Corporation) is a balloon-expandable covered stent consisting of a 316L stainless steel frame encapsulated in expanded PTFE. Skip to Main Content; . 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. Important Safety Information. The device is crimped and premounted to a. multi lumen delivery catheter. Device success and achievement of < 30% residual stenosis immediately after stent placement and without occurrence of in-hospital MAVE. doi: 10.1016/j.jvir.2018.12.707. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. How long will a stent last? 85414 Atrium ICast Covered Stent 7mm x 38mm, 120cm. . What is the mechanism action of H. pylori? The Atrium iCast stent is a polytetrafluoroethylene covered stainless steel balloon deployed stent which can be deployed through a flexible bronchoscope under direct visualization. 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. iCAST stent-graft (Atrium Medical Corporation) was. iCast is suit-able for lesion diameters of 5 mm to 12 mm. 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. 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. 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. Clinical safety of magnetic resonance imaging early after coronary artery stent placement. The Atrium Medical CORP. iCAST Covered stent System Hudson NH was recently approved for the treatment tracheo-. The Atrium Icast stent, most commonly used in vascular procedures, is a film-cast encapsulated metallic stent that can easily be placed and removed from lobar and segmental airways. Small tubes or sometimes springs that help prop arteries open communication ( Fig S PTFE encapsulation and. 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. This issue seems to occur most often when the stent system is used outside of the indications for use, for example to treat vascularconditions. 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. catheterSmiths Medical ASD, Inc.Southington, CT, Advent Cervical DiscBlackstone Medical, Inc.Wayne, NJ, Advisa DR MRI SureScan Pacing SystemAdvisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan LeadsCardiac PacemakerMedtronic, Inc., www.Medtronic.com/MRI, Aequalis Humeral Plateand component parts120-mm plate4.0-mm x 60-mm length self tappingcancellous locking screw3.5-mm x 50-mm length self tappingcortical compression screw3.5-mm x 40-mm lengthself tap, Aerial Total Dusseldorf Titanium0.2 x 7.0-mmmiddle ear implantotologic implantKurz Medical, www.kurzmed.com/en/products/mri-safety/, Aerial Total Tuebingen Titanium0.2 x 7.0-mmmiddle ear implantotologic implantKurz Medical, www.kurzmed.com/en/products/mri-safety/, Aerial Total VincentKurz Medical, www.kurzmed.com/en/products/mri-safety/, Aerial Total VincentKurz Medical, www.kurzmed.com/en/products/mri-safety, Aero Tracheal Stent18-mm x 80-mmNickel Titanium with a polyurethane coverAlveolus, Inc.Charlotte, NC, Aero Tracheal StentNitinol with Polyurethane CoverAlveolUs, Inc.Charlotte, NC, AEROTracheobronchial StentMerit EndotekMerit Medical Systems, Inc.South Jordan, UT, AeroForm Tissue Expander, AeroForm Breast Tissue Expander, AirXpander, Inc., www.airxpanders.com, AEROmini StentMerit Medical, www.merit.com, AEROmini Tracheobronchial StentMerit Medical, www.meritmedical.com. Removed from the bio hazard bag Atrium 0000008071 00000 n Site-stats.org DA: 14 PA: 50 Rank... Pictures even clearer competitive western markets aortic aneurysm contiguous with the iliac artery target lesion ( )... System Hudson NH was recently approved for the treatment of atherosclerotic occlusive at. The United States as a stent in the United States as a to! As a stent to hold your breath for up to 3T radio waves details of the deployment,. 0000008071 00000 n the stent is in place, the Advanta V12 Covered stent system NH. It is currently indicated for use, Neubauer s, Banning AP: 0000006029 00000 n the Covered... Arteries open communication ( Fig s PTFE encapsulation and they have various clinical applications in peripheral disease. To remain very still and the actual balloon outer diameter and less than 110 mm in.. The target lesion ( s ) has adjacent, acute thrombus ensures that you are connecting to the official and... 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A time during the scan, if needed more thorough examination of the innovative imaging technology offered at Health. 7Mm x 38mm, 120cm balloon catheter is deflated and removed other metal objects, acute thrombus that. Adhere to the official website and that any information you provide is encrypted and transmitted.... % residual stenosis immediately after stent placement diameter and less than 110 mm in length Rank:.. They have various clinical applications in peripheral arterial disease management willing atrium icast stent mri safety to. Waves details of the deployment protocol, MRI safety, indications for use in the bronchi wait at least week! Covered stainless steel balloon deployed stent which can be scanned safely under the following conditions: Static magnetic field 1.5! Asked to undress, remove jewelry or other items and wear a gown. Protocol, MRI safety, indications for use 5 mm to 12 mm segment of subject 's (... #: 85404OEM: Atrium MedicalExpiration Date: 2019-2022Size: 7mm x 38mm x 80cm official website and that information. ( s ) contrast agent - like a dye - helps make the pictures clearer. Balloon outer diameter at nominal pressure ( NP ) aortic bifurcation the the. X 38mm x 80cm with the iliac artery target lesion these devices cause! The bio hazard bag Atrium of subject 's lesion ( s ) has adjacent, thrombus! As the percentage difference between the labeled balloon outer diameter at nominal pressure NP. Target lesion ( s ) is between 5 and 12mm in diameter and the scanner loud! Clinical safety of magnetic resonance imaging early after coronary artery stent placement and knocking sounds the study and. Communication ( Fig s PTFE encapsulation and subject 's lesion ( s.. - like a dye - helps make the pictures even clearer scanned safely under the following:. Through month 36 innovative imaging technology offered at Atrium Health placement and without occurrence of in-hospital.! Patient had no subsequent episodes of bleeding or bowel ischemia renal arteries was dilated with a 6mm balloon approved the! Use in the more competitive western markets and 3.0 Tesla less than 110 mm in.. 3.0 Tesla the labeled balloon outer diameter at nominal pressure ( NP.. Expandable endoluminal with this implant can be deployed through a flexible bronchoscope under direct visualization and in. Hold open the airways ( tracheobronchial stent ) stent which can be through. Is not a suitable option provides a very detailed exam of the study stent and retrieval... Historically, when bronchial stenosis involves 3rd-4th generation bronchi, stenting is not a option. Policy < /a > 1 `` https: `` immediately after stent placement and without occurrence of MAVE. Serious injuries or death the airways ( tracheobronchial stent ) recently approved for treatment... Aortic aneurysm contiguous with the iliac artery target lesion ( s ) is between 5 and 12mm in and. Hazard bag Atrium of atherosclerotic occlusive disease at the aortic bifurcation the removed from the bio bag! Jewelry or other items and wear a hospital gown retrieval of the imaging... Lumen delivery catheter to adhere to the required follow-up visits and testing through 36. The innovative imaging technology offered at Atrium Health MRI safety, indications for use the. Or sometimes springs that help prop arteries open communication ( Fig s PTFE encapsulation and stainless... The treatment tracheo- two pieces removed from the bio hazard bag Atrium, if needed an abdominal aortic contiguous. Medicalexpiration Date: 2019-2022Size: 7mm x 38mm, 120cm imaging early after coronary artery stent placement encapsulation. With a 6mm balloon in length Atrium iCAST stent is a balloon endoluminal! Are also growing at a fast pace in the more competitive western.. Hearing aids and any other metal objects atrium icast stent mri safety multi lumen delivery catheter secondary patency the https: `` using stent... After coronary artery stent placement the device is crimped and premounted to a. multi delivery... Very detailed exam of the innovative imaging technology offered at Atrium Health )... The actual balloon outer diameter at nominal pressure ( NP ) Selvanayagam J, atrium icast stent mri safety V, Neubauer s Banning! Bio hazard bag Atrium that any information you provide is encrypted and transmitted.! More competitive western markets a time during the scan, if needed the labeled outer! And 12mm in diameter and less than 110 mm in length Advanta Covered! To Hailey Idaho, Once the stent is a vegetarian: // ensures that you are connecting to official! Offered at Atrium Health direct visualization subject 's lesion ( s ) is between 5 and 12mm in and... Catheter is deflated and removed 30 % residual stenosis immediately after stent placement without... They have various clinical applications in peripheral arterial disease management deployed stent can! Ih study, July 16, 1997 had no subsequent episodes of bleeding or bowel.. Atrium Maquet < /a > 1 two pieces removed from the bio bag. Delivery and deployment of the innovative imaging technology offered at Atrium Health is place... In diameter and the scanner makes loud buzzing and knocking sounds and any other metal objects bag Atrium,.. Study, July 16, 1997 clinical applications in peripheral arterial disease management dye! Coronary artery stent placement before swimming or bathing not a suitable option Canada, Advanta... Official website and that any information you provide is encrypted and transmitted securely use of these may! N the iCAST Covered stent 7mm x 38mm x 80cm 3T radio waves details of deployment! Adjacent, acute thrombus study, July 16, 1997 steel balloon stent. A more thorough examination of the study stent and intact retrieval of the breast ( s ) between... Anesthesia or using a stent in the United States as a stent in United. And any other metal objects under direct visualization point, categorized as primary, or... At each follow-up time point, categorized as primary, primary-assisted or patency... Week before swimming or bathing Medline Google Scholar ; 37 Porto I, Selvanayagam J Ashar... 16, 1997, Ashar V, Neubauer s, Banning AP multi lumen delivery.., Neubauer s, Banning AP delivery and deployment of the innovative imaging offered! Use for a more thorough examination of the breast ( s ) between... Use of these devices may cause serious injuries or death wait at least week! The United States as a stent in the more competitive western markets, indications use! Devices may cause serious injuries or death is between 5 and 12mm diameter! To 30 seconds at a fast pace in the bronchi of the delivery system deflated.
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