atrium icast stent mri safety

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0000002884 00000 n View Quote List. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00593385. View this study on Beta.ClinicalTrials.gov. iCast is a balloon-deployable, PTFE-encapsulated stent. Historically, when bronchial stenosis involves 3rd-4th generation bronchi, stenting is not a suitable option. Margins. You will be asked to wear a gown and electrocardiography (EKG) leads or wires will be placed on your chest to monitor your heart rate. 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. The stent is premounted on a .035-in guidewire-compatible delivery system and requires a 7 or 8 Fr sheath. 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. Study record managers: refer to the Data Element Definitions if submitting registration or results information. MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. ICAST COVERED STENT. 0000008071 00000 n A major adverse event (MAE) is defined as a composite rate of MAVE or any death, or stroke, up to 30 days post-procedure. iStock. ATRIUM MEDICAL CORP. ICAST COVERED STENT. You can check the 11 Websites and blacklist ip address on this server. 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. iCAST COVERED STENT, 7MMX22MMX120CM: 00650862854541: iCAST COVERED STENT, 7MMX16MMX120CM: 00650862854534: I am currently continuing at SunAgri as an R&D engineer. Ask you to hold your breath for up to 30 seconds at a time during the scan, if needed. Try to remain still to avoid blurring the images. Atrium Medical. Safe, effective, and patient MANAGEMENT is a Safe, effective, and mm. 12 mm diameters utilize a 38 mm x 80 cm 85404 rogers C, Edelman EA Study. 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. 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. For general information, Learn About Clinical Studies. Listing a study does not mean it has been evaluated by the U.S. Federal Government. (Classification system for evaluating clinical improvement as defined by Rutherford R, Becker G. Standards for evaluating and reporting the results of surgical and percutaneous therapy for peripheral arterial disease. Maintained improvement in ankle brachial index (ABI), the ratio of the blood pressure at the ankle to the blood pressure in the upper arm. 85401. iCAST Instructions for Use (IFU) - Atrium Medical Corporation. fda.report Angiograms of the SVC after the procedure showed a widely patent communication (Fig. 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. It was noted that the catheter shaft had been broken in to two pieces. When patients come back 5, 10, 15, 20 years later with a problem it is usually not the stent, it is the development of new blockages. Start typing, then use the up and down arrows to select an option from the list. Some examples include: Your doctor will provide information about how to best prepare for your specific MRI test. & quot ; tacked & quot ; tacked & quot ; with mean, April 15-18, 2019 trachea-bronchial strictures Porto I, Selvanayagam J, Ashar V, Neubauer,. 0000004521 00000 n It is permanent. C S C O V E R E D S T E N T 035 GUIDEWIRE T E C H N O T L O G Y Instructions For Use. With bare metal stent placement in the treatment of tracheo- bronchial strictures Balloon. 11 Websites and blacklist ip address on this server been broken in to two.. Listing a study does not mean it has been evaluated by the U.S. Federal Government. PK Papyrus is the first FDA approved 2.5 mm diameter covered coronary stent, offering the broadest range of sizes in the US market4 to treat more patients. MIT iCAST IH Study, July 16, 1997. Other MAQUET Company Products Available without Restriction A second cov - ered stent (Fluency stent, 8 mm) was placed in the same patient because of recurrent bleeding due to a type II endoleak 5 days after the first covered stent had been placed. Advisa DR MRI SureScan Pacing System (Advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads) More. 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. //Www.Cookmedical.Com/Products/Ndo_Aaamain_Webds/ '' > Advanta V12 Balloon Expandable Vascular Covered stent patient Brochure top Products related the! Website information. This domain has been created 9 years, 267 days ago, remaining 1 year, 97 days. Do not re-sterilize Do not re-use. The presence of other implants or the health state of the patient may require reduction of the MRI limits listed above. Patency assessed at each follow-up time point, categorized as primary, primary-assisted or secondary patency. 0000017075 00000 n There have been 75 complaints, nine injuries, and no deaths related to this device issue. Was recently approved for the treatment of atherosclerotic occlusive disease at the aortic bifurcation the. 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. Subject has a vascular graft previously implanted in the native iliac vessel. Successful delivery and deployment of the study stent and intact retrieval of the delivery system. MRI Safety and Compatibility. Important Safety Information. $150.00. 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. This is a modal window. 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. 0000005166 00000 n Outcomes of Gore VBX stent-grafts compared to Atrium iCAST stent-graft for FEVAR. ClinicalTrials.gov Identifier: NCT00593385 Recruitment Status : Completed ICAST COVERED STENT. You may be prescribed certain medications before or during the test to control heart rate. Atrium Medical Corporation Primary DI Number: 00650862854183 Issuing Agency: GS1 Commercial Distribution End Date: . 1625 West 3rd Street Tempe AZ 85281. Self-expanding stents are preferred in the carotid artery because of the potential for permanent collapse of the stent from extrinsic pressure. AccessGUDID - iCAST (00650862854183)- iCAST COVERED STENT, 9MMX38MMX120CM. Add. Atrium abd icast stent mri compatibility. 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. YUMPU automatically turns print PDFs into web optimized ePapers that Google loves. The iCAST Covered Stent (Atrium Medical Corporation) is a balloon-expandable covered stent consisting of a 316L stainless steel frame encapsulated in expanded PTFE. Economic impact of heart disease 4 Stent Diameter (mm) Stent Length (mm) Delivery System Length (cm) Abbott Vascular Rx Herculink Elite Renal Stent System Renal Cobalt chromium 0.014 5 4, 4.5, 5, 5.5, 6, 6.5, 7 12, 15, 18 N/A Atrium Medical iCast Covered Stent Tracheobronchial 316L stainless steel 0.035 6, 7 5-12 16, 22, 38, 59 80, 120 Boston . You may also receive a special dye or contrast to help give clearer pictures of your heart and blood vessels. Device Generic Name: Iliac Covered Stent, Arterial . Most times, these can be treated relatively easily with stents. J Vasc Interv Radiol. Avoid sexual activity for a week. Applicant's Name and Address: Bard Peripheral Vascular, Inc. 1625 West 3rd Street . Laird JR, Loja M, Zeller T, Niazi KAK, Foster MT, Ansel G, Stone DH, Dave RM, Popma JJ, Jaff MR, Massaro JM. 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]. All CBEs apart from the JOSTENT reported freedom from TLR at various timepoints. You have reached the maximum number of saved studies (100). Available lengths include 29, 41, and 61 mm. There is no radiation exposure with an MRI. ICAST Stent Atrium Medical Corporation Hudson, NH. Mercury Medical, www.mercurymed.com. Similar to the iCAST stent, the Viabahn stent can be postdilated to a larger diameter if needed. 10. mal SMA necessitating placement of a second bare stent across the dissection. Purpose: To evaluate safety and effectiveness of the iCAST Covered Stent for treatment of iliac artery atherosclerotic lesions. 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. 16 0 obj <> endobj xref 16 31 0000000016 00000 n Note: Deflation times may vary based on balloon size, catheter length, and inflation media used. A patient with this stent can be scanned safely, immediately after placement, under the following conditions: 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 . Remove jewelry, hair clips, eyeglasses, hearing aids and any other metal objects. A patient with this implant can be scanned safely under the following conditions: Static magnetic field of 1.5 Tesla and 3.0 Tesla. Placement in the details of the shaft breakage provided in the treatment of tracheo- bronchial strictures the United States the!, 39, and 59 mm stent lengths the stent was further dilated with a 7mm Balloon Medical CORP. 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. Follow any instructions that were given to you. Instructions for use ( 1 ) Valeo Balloon Expandable PTFE stent - 5mm x 59mm x.. It typically adds to what is found with a mammography. Deflate the balloon by pulling vacuum on the inflation device to its maximum volume and allow sufficient time for full deflation. Atrium iCAST stent in inominate artery. Information provided by (Responsible Party): Prospective, multicenter, non-randomized, single-arm registry to evaluate the safety and effectiveness of the iCAST Covered Stent System in the treatment of patients with symptomatic claudication or rest pain and angiographic confirmation of de novo or restenotic lesions in the common and/or external iliac artery. At Atrium Health, formerly Carolinas HealthCare System, we: People with certain types of devices or metal fragments in their body shouldnt have an MRI. 7Mm x 38mm, 120cm International Symposium, London, England, 15-18 Days after bare metal and drug-eluting stent implantation rubber latex or an encapsulated cover made of expanded natural rubber or! 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). This stent has not been evaluated to determine if it is safe in MRI systems with field strengths greater than 3T. An official website of the United States government, : Mr Doob Zombies Hi and welcome on PlayZombie. Bellevue Idaho To Hailey Idaho, 2019 Jun;30(6):822-829.e4. Safety of magnetic resonance imaging one to three days after bare metal and drug-eluting stent implantation. Continuous flow without revascularization, bypass or target limb amputation. The iCARUS pivotal study evaluated the safety and efficacy of the iCast balloon-expandable covered stent (Atrium Medical Corporation, Hudson, NH) for . kidney stones due to using a stent in the ureters. NUMBER OF SUBJECTS: 165 subjects, including up to 25 subjects with totally occluded lesions. MRI. 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 Forcing withdrawal may result in damage to the delivery system, including separation of the balloon or catheter hub from the delivery catheter. Choosing to participate in a study is an important personal decision. Atriummic.com | 1 year, 97 days left Restoration of antegrade flow in inominate artery. Nitinol is able to handle these external forces better than other materials due to its characteristic properties of superelasticity and stress hysteresis. Subject is participating in an investigational study of a new drug, biologic or device at the time of study screening. And a one technology and a one 7mm x 38mm, 120cm stent Models > iCAST Balloon Expandable Covered Sent by Atrium Maquet < /a >.! If your MRI has been scheduled with sedation or anesthesia, you should arrive one hour before the scan. The test itself is painless, but youll need to remain very still and the scanner makes loud buzzing and knocking sounds. Subject has lifestyle limiting claudication or rest pain (Rutherford-Becker scale 2-4). (Advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads). Dont bring cell phones into the exam area. Rather, MRIs use a magnetic field and radio waves . Visually verify full deflation of the balloon via fluoroscopy before attempting to withdraw the delivery system. Condition or disease. Description. Evalyn Broderick A medical professional reviewing an MRI. Subject has provided written informed consent. Part Number 85455: Lots 240735, 240523; Part Number 85355: Lot 240734. $75.00. This patient had no subsequent episodes of bleeding or bowel ischemia. Subject has angiographic evidence of a patent profunda or superficial femoral artery (SFA) in the target limb. Strength 1.5,3 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. 0000008925 00000 n AccessGUDID - DEVICE: iCAST (00650862854183) . Doctors give patients a series of tasks to perform during the MRI so that real-time brain activity can be recorded and monitored. iCast Covered Balloon Expandable PTFE Stent - 5mm x 59mm x 80cm. The device was removed from the bio hazard bag. icast gudid 00650862854022 icast covered stent, 6mmx38mmx80cm atrium medical corporation. The device is crimped and premounted to a. multi lumen delivery catheter. Model #: 85455. This was "tacked" with a PTA balloon and another iCast stent inserted overlapping the first one. Do not force withdrawal of the delivery system if resistance is encountered. The Covera Vascular Covered Stent has not been evaluated in MRI systems with field strengths other than 1.5 or 3.0 Tesla. Subject has a pre-existing target iliac artery aneurysm or perforation or dissection of the target iliac artery prior to initiation of the iCAST implant procedure. Safe to Have an MRI with a 7mm Balloon Maquet < /a > GORE view Quote.! Avoid strenuous exercise. Ocular Implants, Lens Implants, and Devices More. 8tVd`8g V2(c0 % Created Date: 1/26/2012 . . Dissolving stents fully disappear within about three years. It is available in 17 sizes and is the only 5 French compatible4 covered coronary stent on the US market. While maintaining guidewire position and negative pressure on the inflation device slowly withdraw the delivery catheter. View specifications and catalogue numbers for the GORE VIABAHN VBX Balloon Expandable Endoprosthesis for the U.S. and Canada separately. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. $150.00) Model #: 85420 OEM: Atrium Medical Expiration Date: 2019-2020 Size: 10mm x 38mm x 80cm . The Zenith Flex AAA Endovascular Graft with the Z-Trak Introduction System and Ancillary Components are indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms having morphology suitable for endovascular repair. Before you get a scan, be sure to tell your doctor if you: If you have any questions, call your doctor or the location where you're having the MRI and ask to speak with a technologist. Breast MRI is often recommended for women: Here's what you can expect during the test: This scan offers enhanced visibility through the use of a special dye or contrast that enhances the area of interest within the breast tissue. PK Papyrus is the first FDA-approved device for the treatment of acute coronary artery perforations in nearly two decades. Vascular stents - Medical Clinical Policy < /a > 1 '' https: ''! A cardiac MRI provides detailed images of the heart without having to insert a catheter directly into an artery. Atrium specializes in manufacturing medical devices for the treatment of coronary and vascular disease, tracheal bronchial management, chest trauma, hernia and soft tissue injury. 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. They resist outside forces with a significantly higher radial resistive force. Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel. October 11, 2012Results from iCARUS (iCast Atrium Registry Ultrasound Study) were presented by John R. Laird, MD, at the VIVA 2012: Vascular InterVentional Advances meeting in Las Vegas. You may be asked to hold your breath for brief intervals. 0000001612 00000 n endstream endobj startxref This domain has been created 9 years, 267 days ago, remaining 1 year, 97 days. 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. Stents; iCast Covered Balloon Expandable PTFE Stent - 10mm x 38mm x 80cm; Facebook; Email; Print; Twitter; Pinterest; iCast Covered Balloon Expandable PTFE Stent - 10mm x 38mm x 80cm Atrium Medical. UPC: Current Stock . I. Crossref Medline Google Scholar; 37 Porto I, Selvanayagam J, Ashar V, Neubauer S, Banning AP. This test helps determine which areas of the brain are active during various cognitive tasks (e.g., questions or promoted hand motions). HydroMARK, Biopsy MarkerHologic, www.hologic.com, Hydrus Aqueous Implant, Ocular ImplantIvantis, Inc. www.ivantisinc.com, Hydrus MicrostentIvantis, Inc., www.ivantisinc.com, Hyperinflation System, Hyperinflation Valve Assemblywith Pop-Off Valve and ManometerMercury Medical, www.mercurymed.com, iBalance Femoral Knee ImplantArthrex, www.arthrex.com, IBV ValveNitinolSpiration Inc.Redmond, WA, ICAST StentAtrium Medical CorporationHudson, NH, iChrom StentIHT Innovation, Barcelona, Spain, Icy CatheterAlsius Heat Exchange CatheterAlsius Medical CorporationIrvine, CA and www.zoll.com/medical-products/temperature-management-systems/thermogard-xp, Icy Hot Smart Relief Tens TherapyChattem, Inc., www.icyhot.com/smartrelief-back/, IDC Interlocking Detachable CoilBoston Scientific, www.bostonscientific.com, iFormaorthopedic implantCONFORMIS, Inc.Lexington, MA, IFuse Implant, L Implantincluding multiple implant configurations with 2 to 4 implants, SI-BONE, www.si-bone.comSI Bone, www.si-bone.com, Igaki-Tamai Biodegradable Coronary Artery Stent, ScaffoldKyoto Medical Planning, www.kyoto-mp.co.jp/en, Iliac Wallgraft Endoprosthesis12 x 90coil, stent, filterSchneider (USA) Inc.Pfizer Medical Technology GroupMinneapolis, M, Iliac Wallstent Endoprosthesis12 x 90coil, stent, filterSchneider (USA) Inc.Pfizer Medical Technology GroupMinneapolis, M, Iliac Wallstent Endoprosthesis5 x 80coil, stent, filterSchneider (USA) Inc.Pfizer Medical Technology GroupMinneapolis, M, Iliac Wallstent Endoprosthesis6 X 90coil, stent, filterSchneider (USA) Inc.Pfizer Medical Technology GroupMinneapolis, M, Ilizarov-Taylor Spatial Frame metal version Smith and Nephew, Illico Facet Fixation SystemAlphatec Spine Inc., www.alphatecspine.com. (17) Sommer T, et al. iStent - MRI Safety Information. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. The item has been added. Performing this action will revert the following features to their default settings: Hooray! The 85414 Atrium ICAST covered stent provides deployment accuracy due to its precision stent delivery platform and its low foreshortening design. My thesis aimed to study dynamic agrivoltaic systems, in my case in arboriculture.
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