W. L. Gore & Associates, Inc. Medical Products Division 3450 West Kiltie Lane Flagstaff, Arizona 86001 Tel 928.779.2771 • Fax 928.779.3480 goremedical.com GORE® EXCLUDER® Device family MRI information Through non-clinical testing, the GORE ® EXCLUDER AAA Endoprosthesis, GORE® EXCLUDER® Conformable AAA Endoprosthesis, and GORE® EXCLUDER® Iliac Branch Endoprosthesis … 3 Isayama H, Mukai T, Itoi T, et al. Key Resources Patient Information Guide Indications, Safety and Warnings Directions for Use The effect of heating in the MRI environment for devices with fractured stent struts is not known. Percutaneous Palliation of Pancreatic Head Cancer: Randomized Comparison of ePTFE/FEP–Covered Versus Uncovered Nitinol Biliary Stents A steel oxygen tank is never permitted inside of the MRI system room. The safety and effectiveness of this device for use in the vascular system has not been established. Flexxus® Biliary Stent Brochure; Flexxus® Endoscopic Biliary Stent Wallchart ; Specifications and Ordering Information Biliary Ln. Read our disclaimer for details. Adverse Events. METHODS: We performed a prospective, single-arm study at six tertiary care centers in Europe. CONTRAINDICATIONS The MERIT ENDOTEK™ EndoMaxx Fully Covered Esophageal Stent is contraindicated in: 1. 2. PMA P160004: FDA Summary of Safety an d Effectiveness Data Page 1 of 43 SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) I. Floor polishers are poor MRI system cleaners! There is significantly improved bile drainage. GORE® VIABIL® Biliary Endoprosthesis with EPTFE GORE® VIABIL® Product Overview Engineered of proprietary design and material, the fully covered GORE ® VIABIL ® Biliary Endoprosthesis has helped the palliation of symptoms caused by malignant biliary obstruction. The safety of the deployment catheter in the MR environment has not been evaluated, and therefore, the deployment catheter should not be used within the MR environment. Familiarity with the imaging patterns will allow proper interpretation of the MRI findings. Hardbound MRI Textbook. AW0165-EN1. The question of whether having an MRI with a stent is safe usually stems from a fear that the magnetic field generated by the MRI will displace the stent. Flagstaff, AZ: W. L. Gore & Associates, Inc; 2017. Stent, the GORE® VIABIL ® Biliary Endoprosthesis has low Af and moderate Rf, the preferred combination for reducing migration and achieving higher patency.4 STRAIGHTENING AXIAL FORCE Higher primary patency Clinical performance demonstrates GORE ® VIABIL Biliary Endoprosthesis maintains higher primary patency than the leading competitor at 3, 6, and 12-months.5,6 Improved … … Flared stent ends provide excellent stent anchoring within the duct, significantly reducing the potential for migration; One-click single handed pistol grip delivery easy-to-use; Documents LITERATURE. OBJECTIVE: The objective of this study was to evaluate the efficacy and safety of this treatment modality using an fcSEMS with a special antimigration design and prolonged stent indwell time. It uses a four stage twist and pull deployment system for easy placement. The majority of modern coronary artery stents are made from materials that do not displace as a result of an MRI, and as such, even the strongest magnetic waves won’t impact them. GORE® VIABIL® Biliary Endoprosthesis Assurance Brochure. Buy (Conmed Gore Viabil Metal Biliary Endoprosthesis Stents)It is a flexible fully covered, self expanding metal stent constructed from nitinol and an integrated ultra-thin, non-porous ePTFE or FEP inner lining. Cholangiogram following covered stent placement. It features exclusive pull-line deployment. GENERAL INFORMATION Device Generic Name: Stent, Superficial Femoral Artery Device Trade Name: GORE TIGRIS Vascular Stent Device Product Code: NIP Applicant’s Name and Address: W.L. Box 2400 … ®– GORE VIABIL® Biliary Endoprosthesis: 10% (3/30) - 2 peritoneal irritation, 1 biloma formation ®– WALLSTENT : 13.3% (4/30) - 3 peritoneal irritation, 1 self limited biliary hemorrhage n Conclusions “In conclusion, Viabil [GORE ® VIABIL Biliary Endoprosthesis] stents have been shown to be safe … For additional information regarding MRI please refer to the product Instructions for Use. AccessGUDID - GORE VIABIL Biliary Endoprosthesis (00733132638826)- No description. An office chair was in the wrong place - at ANY time! The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. MRI of the Viatorr stent-graft is feasible for the initial assessment of the TIPS. MRI BIOEFFECTS, SAFETY, AND PATIENT MANAGEMENT is a comprehensive, authoritative textbook on the health and safety concerns of MRI technology that contains contributions from more than forty internationally respected experts in the field. The catheter provides a means for implanting the GORE® VIABIL® Short Wire Biliary Endoprosthesis at the target site in the biliary tract. Carotid Stent Design Muller-Hulsbeck et al. MRI Safety and Compatibility: Non-clinical testing has demonstrated that the Endurant II Stent Graft is MR Conditional. Comparison of partially covered nitinol stents with partially covered stainless stents as a historical control in a multicenter study of distal malignant biliary obstruction: the WATCH study. T1-weighted gadolinium-enhanced image of Viatorr stent-graft (W. L. Gore & Associates) with phase-encoding gradient oriented perpendicular (A), along (B), and at 45° angle (C and D) to long axis of stent. Note distinct reduction of signal from open segment of stent with stent oriented perpendicular to phase-encoding gradient. Diese sind jedoch für Stents völlig unproblematisch, wie eine Reihe von Studien gezeigt hat. GMDN Preferred Term Name GMDN Definition; Polymer-metal biliary stent A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to … J Endovasc Ther 2009;16:168. A group of researchers in Texas in 1998 reviewed all … • No clinical events related to heating effects of GORE® VIABAHN® Endoprostheses with Heparin Bioactive Surface in the MRI environment have been reported. Flexxus® Biliary Stent 8.00 X 100.00mm. Effect is less pronounced with stent oriented at 45° Following stent placement, intrastent debris was identified and swept into the bowel using a 10-mm angioplasty balloon. Multicenter Study of Removable GORE VIABIL® Biliary Endoprosthesis for Treatment of Benign Biliary Strictures. Patients with significantly abnormal coagulopathy. MRI also allows the depiction of detailed anatomic information concerning stent positioning. The GORE® VIABIL® Short Wire Biliary Endoprosthesis is a flexible endoprosthesis (stent) that is radially compressed and secured onto the distal end of a delivery catheter. Was viele Menschen belastet, ist die Frage, ob MRT-Untersuchungen mit Stents möglich sind. 3). Gore, Flagstaff, AZ) stent was deployed within the previously placed LUMINEXX stent (Fig. Other devices implanted for less than 30 days may interfere with the deployment of the GORE® VIABAHN® Endoprosthesis with Heparin Bioactive … The Wallstent Endoprosthesis Stent has been engineered to combine a unique stent design with a minimal free cell area, and a highly flexible, intuitive delivery system. The GORE® Carotid Stent is used to re-open narrowed regions of the carotid arteries in the neck which supply blood to the brain. Wholey J Endovasc Ther 2009;16:178 Carotid Stent Design Open Cell In Tortuous Bifurcation. [Flyer]. The GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion, a new device configuration developed by W. L. Gore & Associates, Inc. (Gore), may further reduce portal hypertension treatment complications, even compared to the GORE® VIATORR® TIPS Endoprosthesis, Gore’s legacy TIPS device, which has a strong history of patency and proven performance at fixed diameters. Conmed Gore Viabil Metal Biliary Endoprosthesis Stents is a flexible fully covered, self expanding metal stent constructed from nitinol and an integrated ultra-thin, non-porous ePTFE (Expanded Polyetraflourethylene) or FEP (Flourinated Ethylene Propylene) inner lining. The ConMed Gore Viabil Biliary Endoprosthesis is a self expandable metal stent which is used to alleviate the symptoms caused by malignant biliary obstructions. A 10 mm × 4 cm Viabil (W.L. The GORE VIABAHN Endoprosthesis is the only stent or stent-graft to receive U.S. Food and Drug Administration approval for use in the superficial femoral artery (SFA) (including de novo or restenotic lesions and in-stent restenosis of bare metal stents), iliac artery, and arteriovenous (AV) access. Potential Adverse Events: Potential complications may be found in the product labeling supplied with each device. The AAA stent is placed within the aneurysm to provide a permanent, alternative conduit for blood flow within the patient’s vasculature, thereby excluding the aneurysmal sac from blood flow and pressure and preventing the walls of the aneurysm from rupturing. Consult the Directions for Use for additional Warnings. Gore & Associates, Inc. 3250 West Kiltie Lane, P.O. It can be scanned safely in both 1.5T & 3.0T MR systems under certain conditions as described in the product Instructions for Use. Endovascular Aortic Repair (EVAR) EVAR of the abdominal aorta is performed using an AAA stent graft. The stated stent length on the catheter equals the measurement of the delivered stent. Sie befürchten, dass sich durch die Magnetresonanztomografie die Stents verengen könnten, da bei der Untersuchung mit Magnetfeldern und Radiowellen gearbeitet wird. Endoprosthesis with Heparin Bioactive Surface within stents or stent grafts (other than the GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface or the GORE® VIABAHN® Endoprosthesis) that have been implanted for less than 30 days. Patients with necrotic, chronically bleeding or polypoid lesions. MRI Safety and Compatibility MRConditional Endoprosthesis. Increased DW-MRI Hits With Open Cell Stents. Figure 3. Listing a study does not mean it has been evaluated by the U.S. Federal Government. 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