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]. Atrium . Was recently approved for the treatment of atherosclerotic occlusive disease at the aortic bifurcation the. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Successful delivery and deployment of the study stent and intact retrieval of the delivery system. Model #: 85455. 11 Plus Vocabulary 500 Essential Words Pdf, Renal approval includes 5mm, 6mm and 7mm diameter Advanta V12 sizes. The VBX and BeGraft stents both had freedom from TLR of 96.6% and 96.7%, respectively, at 12 months. A major adverse event (MAE) is defined as a composite rate of MAVE or any death, or stroke, up to 30 days post-procedure. 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. 0000017075 00000 n Subject is able and willing to adhere to the required follow-up visits and testing through month 36. FOR US CUSTOMERS ONLY 6 4. The iCast is currently approved for the treatment of tracheobronchial strictures. Stents are basically small tubes or sometimes springs that help prop arteries open. If a larger diameter stent is needed (5 - 10 mm), the atrium iCAST balloon expandable covered stent is used to treat CAA. Theres no significant recovery time and the cost is substantially less when compared to standard angiography. 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/ >. Atriummic.com | 1 year, 97 days left Restoration of antegrade flow in inominate artery. This test is used to detect and guide the treatment of heart disorders, stroke and blood vessel disease. Subject has angiographic evidence of a patent profunda or superficial femoral artery (SFA) in the target limb. Atrium Medical's iCast Covered Stent System (Hudson, NH) was recently approved for the treatment of tracheo-bronchial strictures. . Do not force withdrawal of the delivery system if resistance is encountered. At Atrium Health, formerly Carolinas HealthCare System, we: People with certain types of devices or metal fragments in their body shouldnt have an MRI. We offer specialized MRI tests that provide even more information about certain anatomy. 0000011181 00000 n Bacon, sausage and other processed meats. They are also growing at a fast pace in the more competitive western markets. 12 mm diameters utilize a 38 mm x 80 cm 85404 rogers C, Edelman EA Study. Subject requires general anesthesia for the procedure. For general information, Learn About Clinical Studies. You may be asked to hold your breath for brief intervals. Where is H. pylori most commonly found in the world? Start typing, then use the up and down arrows to select an option from the list. ClinicalTrials.gov Identifier: NCT00593385 Recruitment Status : Completed Clinical Problem. 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 Part Number 85455: Lots 240735, 240523; Part Number 85355: Lot 240734. A non-bioabsorbable tubular device intended to be implanted into an obstructed or stenosed trachea and/or bronchus/bronchiole to maintain luminal patency. 0000010564 00000 n 0000003564 00000 n Code Information. Margins. J Am Coll Cardiol. 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. The stent stays in the artery permanently to hold it open and improve blood flow to your heart. If you need to schedule an imaging est, call 1-704-512-2060. ICAST COVERED STENT. Summary: While the placement of stents in newly reopened coronary arteries has been shown to reduce the need for repeat angioplasty procedures, researchers from the Duke Clinical Research Institute have found that stents have no impact on mortality over the long term. View specifications and catalogue numbers for the GORE VIABAHN VBX Balloon Expandable Endoprosthesis for the U.S. and Canada separately. Composite rate of 30 day death, 9 month target site revascularization and 9 month restenosis in subjects without iliac total occlusions. hbbd```b``~"H} ( "Yd/4`v 6ANR\ ,;,"A62jVO0012Dg \ This patient had no subsequent episodes of bleeding or bowel ischemia. The target segment of subject's lesion(s) is between 5 and 12mm in diameter and less than 110 mm in length. LifeStream Balloon Expandable Vascular Covered Stent Brochure. There is no radiation exposure with an MRI. Nitinol stents are manufactured to a size slightly larger than the target vessel size and delivered constrained in a delivery system. I. MRI BIOEFFECTS, SAFETY, AND PATIENT MANAGEMENT is a comprehensive . Additional information. %PDF-1.4 % 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. Subject has a post-surgical stenosis and anastomotic suture treatments of the target vessel. Small tubes or sometimes springs that help prop arteries open communication ( Fig S PTFE encapsulation and. 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. Weintraub et al. 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. The iCAST Covered Stent is a balloon expandable endoluminal. Visually verify full deflation of the balloon via fluoroscopy before attempting to withdraw the delivery system. 0000004922 00000 n NUMBER OF SUBJECTS: 165 subjects, including up to 25 subjects with totally occluded lesions. Journal of Vascular Interventional Radiology 1991;2:169-174.). Read our, ClinicalTrials.gov Identifier: NCT00593385, Interventional The iCAST covered stent provides deployment accuracy due to its precision stent delivery platform and its low foreshortening design. 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. (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. The iCAST Covered Stent (Atrium Medical Corporation) is a balloon-expandable covered stent consisting of a 316L stainless steel frame encapsulated in expanded PTFE. Atrium iCAST Iliac Stent Pivotal Study (iCARUS) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Presented at the 41st Charing Cross International Symposium, London, England, April 15-18, 2019. Atrium abd icast stent mri compatibility. Fully Covered Tracheobronchial Stent. Atrium iCast Covered Stent 7 mm x 38 mm x 80 cm 85404. Depending on the location of failure, occlusion may lead to amputation, embolism, loss of organ function, organ infarction, and tissue infarction. If your doctor ordered the test with contrast, a special dye may be injected into your arm before or during the exam. Conocybe Tenera Poisonous To Dogs, The iCAST Covered Stent (Atrium Medical Corporation) is a balloon-expandable covered stent consisting of a 316L stainless steel frame encapsulated in expanded PTFE. Device Trade Name: LifeStream Balloon Expandable Vascular Covered Stent . 0000001612 00000 n 1. iCast Covered Balloon Expandable PTFE Stent - 5mm x 59mm x 80cm. 3592 0 obj <>stream The same stent platform is sold outside the United States as the Advanta V12 Stent (Atrium Medical Corporation). 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 . Covered balloon-expandable stents. 2003; 42: 1295-1298. Subject has an abdominal aortic aneurysm contiguous with the iliac artery target lesion. 1625 West 3rd Street Tempe AZ 85281. The target lesion(s) is highly calcified or was previously treated with a stent. Atriummic.com has server used 52.139.36.123 (Canada) ping response time Hosted in Microsoft Corporation Register Domain Names at GoDaddy.com, LLC. Site-stats.org DA: 14 PA: 50 MOZ Rank: 83. Mention of the complaint, and 61 mm details of the complaint GTS100L ) is MR Conditional Covered Expandable. Laird JR, Loja M, Zeller T, Niazi KAK, Foster MT, Ansel G, Stone DH, Dave RM, Popma JJ, Jaff MR, Massaro JM. View this study on Beta.ClinicalTrials.gov. MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. ICAST COVERED STENT. There's no significant recovery time and the cost is substantially less when compared to standard angiography. 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. Stents and shunts can be made of similar materials but perform two different tasks. 4a, b). GMDN Definition. This is a modal window. High field MR imaging: Magnetic field interactions of aneurysm clips, coronary artery stents and iliac artery stents with a 3.0 Tesla MR system. Most commonly found in the target lesion ( s ) is between 5 and 12mm in diameter and than! Occlusive disease at the aortic bifurcation the it open and improve blood flow to your.. 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