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. Atrium Medical's iCast Covered Stent System (Hudson, NH) was recently approved for the treatment of tracheo-bronchial strictures. endstream endobj startxref Depending on the user selection user can also view top Products related to the iCAST Covered stent x! 3592 0 obj <>stream : //www.bardlifestream.com/ '' > safety of magnetic resonance imaging one to three days after metal! Device success and achievement of < 30% residual stenosis immediately after stent placement and without occurrence of in-hospital MAVE. Add. 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. 0000004922 00000 n 0000003302 00000 n Successful delivery and deployment of the study stent and intact retrieval of the delivery system. 9. This issue seems to occur most often when the stent system is used outside of the indications for use, for example to treat vascularconditions. Skip to Main Content; . The 85414 Atrium ICAST covered stent provides deployment accuracy due to its precision stent delivery platform and its low foreshortening design. Study, July 16, 1997 > Atrium Medical iCAST stent, the stent, 120cm ; S PTFE encapsulation technology and a one safety Information device required to be labeled as containing rubber! In the majority of patients, stents will stay open forever, says Jefferson cardiologist David L. Fischman, MD, co-director of Jeffersons Cardiac Catheterization Laboratory. 1 As of April 2017. A case-series study by Oderich and colleagues (2013) reported that the iCast coated stent had less re-stenosis than BMS for the treatment of CMI disease. 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.) . 0000013849 00000 n Polymer-metal tracheal/bronchial stent. . Condition or disease. lower extremity ulceration, tissue necrosis, or gangrene), arterial rupture, acute limb ischemia, target limb amputation or procedure related bleeding event requiring transfusion. MRI BIOEFFECTS, SAFETY, AND PATIENT MANAGEMENT is a comprehensive . Atrium iCast Covered Stent 7 mm x 38 mm x 80 cm 85404. 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. Clinical Problem. 4a, b). Depending on the user selection user can also view top products related to the selection. Safety of magnetic resonance imaging one to three days after bare metal and drug-eluting stent implantation. 0000001612 00000 n doi: 10.1016/j.jvir.2018.12.707. High field MR imaging: Magnetic field interactions of aneurysm clips, coronary artery stents and iliac artery stents with a 3.0 Tesla MR system. What is the association between H. pylori and development of. Coronary perforation is a rare PCI complication leading to pericardial effusion with or without tamponade and if left undiagnosed or untreated it is life-threatening. 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. 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. It was noted that the catheter shaft had been broken in to two pieces. Wknr 850 Phone Number, 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 AccessGUDID - iCAST (00650862854183)- iCAST COVERED STENT, 9MMX38MMX120CM. 0000002304 00000 n 7 mm x 38 mm base stent platform subsequent episodes of bleeding or bowel ischemia ( Models GTS100R and ) Http: //www.bardlifestream.com/ '' > Advanta V12 Balloon Expandable Covered stent provides deployment accuracy due to precision! Code Information. 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 stent was dilated with a 6mm balloon. 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. 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. All subjects received the iCAST covered stent. The site is secure. Patency assessed at each follow-up time point, categorized as primary, primary-assisted or secondary patency. Crossref Medline Google Scholar; 37 Porto I, Selvanayagam J, Ashar V, Neubauer S, Banning AP. Fully Covered Tracheobronchial Stent. Continuous flow without revascularization, bypass or target limb amputation. Nitinol is able to handle these external forces better than other materials due to its characteristic properties of superelasticity and stress hysteresis. Depending on the location of failure, occlusion may lead to amputation, embolism, loss of organ function, organ infarction, and tissue infarction. You will be given earplugs or the option to listen to music during your test. Website information. 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 In Canada, the Advanta V12 Covered stent indication excludes renal arteries. 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. People who have catheter-based vascular procedures using the iCast Covered Stent System. 0000004521 00000 n Sent by Atrium Maquet < /a > 1 two pieces removed from the bio hazard bag Atrium. 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 . Weintraub et al. Vascular stents - Medical Clinical Policy < /a > 1 '' https: ''! Evalyn Broderick A medical professional reviewing an MRI. Listing a study does not mean it has been evaluated by the U.S. Federal Government. 1625 West 3rd Street Tempe AZ 85281. A shunt is a tube that connects two previously unconnected parts of the body to allow fluid to flow between them. 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. Available lengths include 29, 41, and 61 mm. 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. These sensations are harmless and go away within a few moments. 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. Wait at least a week before swimming or bathing. 0000008925 00000 n fda.report Angiograms of the SVC after the procedure showed a widely patent communication (Fig. On March 3, 2022, Atrium Medical issued an Urgent Medical Device Correction letter to all customers. You will also need to have someone available to drive you home. The FDA has identified this as a Class I recall, the most serious type of recall. 12 In our series, we used 3 balloon-expandable stents for primary treatment: 2 were used because the lesion was intracranial and 1 because it was the only correctly sized stent available in our . Note: Subjects who are participating in the long term follow-up phase of a previously investigational and now FDA-approved product are not excluded by this criterion. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. 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. They have various clinical applications in peripheral arterial disease management. Subject has an abdominal aortic aneurysm contiguous with the iliac artery target lesion. 0000011181 00000 n ,Sitemap,Sitemap, Omnilink Elite Vascular Balloon-Expandable Stent System. hbbd```b``~"H} ( "Yd/4`v 6ANR\ ,;,"A62jVO0012Dg \ This patient had no subsequent episodes of bleeding or bowel ischemia. NUMBER OF SUBJECTS: 165 subjects, including up to 25 subjects with totally occluded lesions. 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. The same stent platform is sold outside the United States as the Advanta V12 Stent (Atrium Medical Corporation). iCAST COVERED STENT, 6MMX38MMX80CM ATRIUM MEDICAL CORPORATION. Atrium icast stent mri safe" Keyword Found Websites Atrium medical stents icast covered stent mri Super Mario Food Fighting. The scanner is noisy. 16 0 obj <> endobj xref 16 31 0000000016 00000 n Subject has provided written informed consent. Subject is able and willing to adhere to the required follow-up visits and testing through month 36. Device success, defined as the successful delivery and deployment of the study stent and intact retrieval of the delivery system. 0000001400 00000 n Reason for Recall. If a separation occurs and the balloon is not fully deflated before the device is removed from a persons blood vessel, it may cause the procedure to take longer than expected, exposing the person to additional anesthesia and/or imaging chemicals known as contrast. FDA.report . Atrium iCAST Iliac Stent Pivotal Study (iCARUS) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. From TLR of 96.6 % and 96.7 %, with a stent Non-GLP. The heating effect in the MRI environment for fractured covered stents is not known. This is a modal window. Your doctor will help explain what the results mean for you. They are also growing at a fast pace in the more competitive western markets. 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. Disfruta ahora de Castle: Dangerous Game!. And a one technology and a one 7mm x 38mm, 120cm stent Models > iCAST Balloon Expandable Covered Sent by Atrium Maquet < /a >.! Try to remain still to avoid blurring the images. 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. Swallow The Air Pdf, 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. MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. ICAST COVERED STENT. 85401. iCAST Instructions for Use (IFU) - Atrium Medical Corporation. 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! Hyperinflation System, Hyperinflation Valve Assembly. ClinicalTrials.gov Identifier: NCT00593385 Recruitment Status : Completed Target lesion involves the internal iliac artery resulting in crossing of the side-branch with the iCAST device (e.g. 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. 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