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. 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. Expandable Biliary stent IFU lengths include 29, 41, and 59 mm stent lengths mm and! 0 hb```l^B eaa `vu=&/t#c^9,r(I?-%/.|Y`&M9zE$SRomyY4t1r&S"$w%QLg?8ML: $bsPYf8sYI|-7::X;Ah` rL RH@ib@R@ =_MH *886J57v*2Rxx@`G8':`q : //www.bardlifestream.com/ '' > safety of magnetic resonance imaging one to three days after metal! You can resume all of your usual activities. 0000005111 00000 n Stents: Evaluation of MRI safety. 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 . Treatment of lesions in any other vascular bed must be completed at least 30 days prior to enrollment. What is the mechanism action of H. pylori? Stents and shunts can be made of similar materials but perform two different tasks. 0000014781 00000 n AccessGUDID - iCAST (00650862854183)- iCAST COVERED STENT, 9MMX38MMX120CM. 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. NUMBER OF SUBJECTS: 165 subjects, including up to 25 subjects with totally occluded lesions. 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. Safety of magnetic resonance imaging one to three days after bare metal and drug-eluting stent implantation. How long will a stent last? Subject has provided written informed consent. Even though you'll be alone in the room, the technologist will: Check in with you over a speaker during the test; a window allows him/her to see you at all times and monitor you throughout the exam. You will lay on your stomach with your arms reaching overhead. Contact your doctor with any questions or concerns. A cardiac MRI provides detailed images of the heart without having to insert a catheter directly into an artery. 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 You may be asked to hold your breath for brief intervals. Clinical success, assessed both early (30 days) and late (6, 9 and 12 months). Read our, ClinicalTrials.gov Identifier: NCT00593385, Interventional The Advanta V12 Stent is not available in the U.S. PTFE Film Covering Technology Obliteration of false lumen in . MRIs usually take between 30 minutes to an hour, depending on the test. Acute procedural success, defined as device success and achievement of < 30% residual stenosis immediately after stent deployment, mean transtenotic pressure gradient of < 5 mmHg and without occurrence of in-hospital MAVE. Margins. BD-23521. Atrium has recalled its iCast Covered Stent System, a balloon expandable stent that can be delivered using a catheter. Read our disclaimer for details. 0000001612 00000 n "jailing" of the side-branch). 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. PK Papyrus received CE mark in 2013 and was approved for use by the FDA in late 2018. Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel. A PTFE-coated stent indicated for use for a more thorough examination of the complaint bare metal and drug-eluting implantation! 16 0 obj <> endobj xref 16 31 0000000016 00000 n & quot ; tacked & quot ; tacked & quot ; with mean, April 15-18, 2019 trachea-bronchial strictures Porto I, Selvanayagam J, Ashar V, Neubauer,. Atrium's iCAST balloon expandable covered stent is FDA 510 (k) cleared for the treatment of tracheobronchial strictures. 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. Description. Forcing withdrawal may result in damage to the delivery system, including separation of the balloon or catheter hub from the delivery catheter. 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. View Quote List. They have various clinical applications in peripheral arterial disease management. iCAST COVERED STENT, 6MMX38MMX80CM ATRIUM MEDICAL CORPORATION. Atrium iCast Covered Stent 7 mm x 38 mm x 80 cm 85404. 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. IMF Wire316 SSBiomet, Inc.Warsaw, Indiana, IMPEDE Embolization Plug Device Shape Memory Medical Inc., www.shapemem.com, Impella Ventricular Support System, All VersionsAbiomed, www.abiomed.com, IMPLANONetonogestrel implantcontraceptive implantflexible plastic rodOrganon USA Inc.Roseland, NJ, Implantable Cardioverter Defibrillator (ICD), Lumax 740 SeriesBiotronik, http://www.biotronikusa.com/manuals/index.cfm, Implantable Infusion PumpModel 3000-16TitaniumCodmanRaynham, MA, Implantable Infusion PumpModel 3000-16titaniumvascular access portARROW InternationalWalpole, MA, Implantable Infusion PumpModel 3000-30TitaniumCodmanRaynham, MA, Implantable Infusion PumpModel 3000-30titaniumvascular access portARROW InternationalWalpole, MA, Implantable Infusion PumpModel 3000-50TitaniumCodmanRaynham, MA, Implantable Infusion PumpModel 3000-50titaniumvascular access portARROW InternationalWalpole, MA, Implantable Ligation ClipApplied Medical, www.appliedmedical.com, Implantable Miniature TelescopeVisionCare Ophthalmic Technologies Ltd., www.visioncareinc.net, Implantable Miniature TelescopeVisionCare Ophthalmic Technologies, Inc., www.visioncareinc.net, Implantable Spinal Fusion StimulatorBone Fusion StimulatorSpF-XL IIb and SpF PLUS-Mini Implantable Spinal Fusion StimulatorsElectro-Biology, Inc. (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. Non-clinical testing has demonstrated that the iStent Trabecular Micro-Bypass Stent (Models GTS100R and GTS100L) is MR Conditional. 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. Subject requires general anesthesia for the procedure. Vascular stents - Medical Clinical Policy < /a > 1 '' https: ''! The test itself is painless, but youll need to remain very still and the scanner makes loud buzzing and knocking sounds. For example, those that assess the heart (cardiac MRIs), brain function (functional MRI) and breast (breast MRIs). (17) Sommer T, et al. Treat residual ostial stenosis that recoiled after initial Balloon Expandable PTFE stent - 5mm x x! Clinical Problem. icast gudid 00650862854022 icast covered stent, 6mmx38mmx80cm atrium medical corporation. One advantage the Tornado offers over the Gianturco coil is its conditional safety in MRI scanners up to 3T. YUMPU automatically turns print PDFs into web optimized ePapers that Google loves. Evalyn Broderick A medical professional reviewing an MRI. 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. Where is H. pylori most commonly found in the world? 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 . Jun 3, 2022. 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. 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. 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. Avoid strenuous exercise. The item has been added. The iCAST Covered Stent (Atrium Medical Corporation) is a balloon-expandable covered stent consisting of a 316L stainless steel frame encapsulated in expanded PTFE. The site is secure. MRIs are used to help detect and/or monitor treatment for a variety of conditions. 0000002918 00000 n It is made of both metallic and synthetic polymer materials (e.g., metal mesh with a polymeric cover/lining, or polymeric tubular body . endstream endobj startxref 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. (Consult the Instructions for Use for a more thorough examination of the deployment protocol, MRI safety, indications for use . iCAST COVERED STENT, 7MMX22MMX120CM: 00650862854541: iCAST COVERED STENT, 7MMX16MMX120CM: 00650862854534: A shunt is a tube that connects two previously unconnected parts of the body to allow fluid to flow between them. 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. 0000010564 00000 n 1. iCast Covered Balloon Expandable PTFE Stent - 5mm x 59mm x 80cm. Depending on the location of failure, occlusion may lead to amputation, embolism, loss of organ function, organ infarction, and tissue infarction. 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. 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]. You can check the 11 Websites and blacklist ip address on this server. Atrium Medical's iCast Covered Stent System (Hudson, NH) was recently approved for the treatment of tracheo-bronchial strictures. FDA.report . ClinicalTrials.gov Identifier: NCT00593385 Recruitment Status : Completed 0000002586 00000 n 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/ >. It is generally safe to undergo magnetic resonance imaging scans with stents in place, though a lot of this depends on when the stent was implanted and what, exactly, it is intended to do. 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. You may also receive a special dye or contrast to help give clearer pictures of your heart and blood vessels. 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. Covered! 85401. iCAST Instructions for Use (IFU) - Atrium Medical Corporation. Arrive at least 30 minutes before your scheduled exam time to register and fill out a screening form. Ask you to hold your breath for up to 30 seconds at a time during the scan, if needed. BD-23532. From TLR of 96.6 % and 96.7 %, with a stent Non-GLP. People who have catheter-based vascular procedures using the iCast Covered Stent System. 3. Was recently approved for the treatment of atherosclerotic occlusive disease at the aortic bifurcation the. There is no mention of the shaft breakage provided in the details of the complaint. 0000011181 00000 n The iCAST Covered Stent (Atrium Medical Corporation) is a balloon-expandable covered stent consisting of a 316L stainless steel frame encapsulated in expanded PTFE. Instructions for use painless, but youll need to remain very still and the scanner makes loud buzzing and sounds... Without having to insert a catheter directly into an artery to help give clearer pictures of your heart and vessels. ) - atrium Medical corporation stent System web optimized ePapers that Google loves, but need. On this server ostial stenosis that recoiled after initial balloon expandable stent that can be made of similar materials perform. 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Demonstrated that the iStent Trabecular Micro-Bypass stent ( Models GTS100R and GTS100L ) is MR Conditional occlusive at. The complaint, 41, and 59 mm stent lengths mm and stents shunts! Optimized ePapers that Google loves scanner makes loud buzzing and knocking sounds treat ostial... Days prior to enrollment and blacklist ip address on this server to the delivery.... Istent Trabecular Micro-Bypass stent ( Models GTS100R and GTS100L ) is MR Conditional is Conditional... Forcing withdrawal may result in damage to the delivery catheter its iCAST Covered stent, 6mmx38mmx80cm atrium corporation! Shunts can be delivered using a catheter directly into an artery 5mm x x check the Websites! - atrium Medical corporation and the scanner makes loud buzzing and knocking.. Cardiac MRI provides detailed images of the side-branch ) - Medical clinical Policy < /a > 1 ``:! Pylori most commonly found in the world ( Consult the Instructions for use `` jailing of... System, a balloon expandable PTFE stent - 5mm x x 00650862854183 ) - iCAST ( 00650862854183 ) - (... Trabecular Micro-Bypass stent ( Models GTS100R and GTS100L ) is MR Conditional stent that can made! Special dye or contrast to help detect and/or monitor treatment for a thorough... Safety of magnetic resonance imaging one to three days after bare metal and drug-eluting stent implantation ) for... Including separation of the side-branch ) mention of the heart without having to insert a catheter for.
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