<>stream Flagstaff, AZ: W. L. Gore & Associates, Inc; 2017. The complete line of WallFlex Biliary RX Stents -- Fully Covered, Partially Covered and Uncovered -- have previously received CE Mark and FDA clearance for the palliative treatment of malignant biliary strictures. 0000002120 00000 n "Boston Scientific continues to fulfill our promise to deliver industry-leading, innovative technologies that enable physicians to best diagnose and treat digestive diseases, and enhance quality of life for patients," said Michael Phalen, President, Boston Scientific Endoscopy. Flagstaff, AZ: W. L. Gore & Associates, Inc; 2017. Indication: The EverFlex™ self-expanding peripheral stent system is intended to improve luminal diameter in the treatment of symptamotic de novo or restenotic lesions up to 180 mm in length in the native superficial femoral artery and/or proximal popliteal arteries with reference vessel diameters ranging from 4.5 mm – 7.5 mm. 65 0 obj<>stream Coron Artery Dis 2009; 20:138-42. <> MRI laboratory evaluation demonstrated that no significant image distortion or heating was created by the presence of the stents at scanning sequences commonly used during MRI procedures. Cook Medical Zilver Stent - Independent Reviews by … This device is the biliary version of Boston Scientific's Wallstent. AccessGUDID - WallFlex™ Biliary (08714729759256)- Stent System. Acrobat Distiller 10.1.16 (Windows) The system is available in 150cm shaft length… Formula 418 RX … 1.5,3: Safe More... Coils, Filters, Stents, and Grafts More... Polaris Ultra Dual Durometer Ureteral Stent Boston Scientific Corporation www.bostonscientific.com. endobj Boston Scientific has an exclusive worldwide license to market and distribute the NIR stent. Outside the US MRI safety information - heart valve products. 35 0 obj Polymeric biliary stent, non-bioabsorbable A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. The WallFlex Biliary RX Uncovered Stent System is provided sterile using ethylene oxide and is a single use device. The safety and effectiveness of this device for use in the vascular system have not been established. endstream endobj 37 0 obj<> endobj 38 0 obj<> endobj 39 0 obj<> endobj 40 0 obj<>stream trailer MagneticiResonance Coodillcnal 3.0 Testa Temperature Information Contact the Edwards Lifesciences technical support department at 800-822-9837 (USA) or 949-250-2500 for any additional information regarding MRI safety … 0000004699 00000 n 0000033624 00000 n Precautions. conventional spin echo pulse sequence. 0000006785 00000 n Ultraflex stent (Boston Scientific, Natick, MA, USA) The Ultraflex stent used in the esophagus is a single layer of braided, knitted flexible nitinol and can be either covered (polyurethane) or uncovered. The stent is a laser cut self-expanding stent composed of a nickel titanium alloy (nitinol). Last update. In Spin Echo and Gradient Echo sequence evaluations Neuroform stent image artifact extended approximately 2mm from the device. endobj xref In combinaison with Boston Scientific compatible MRI leads. 0000007958 00000 n RESONATE DAI (D432, D433) Field strength. 79 0 obj <> W. L. Gore & Associates, Inc. Migration Summary for GORE® VIABIL® Biliary Endoprosthesis and Boston Scientific WALLFLEX Biliary RX Fully Covered Stent. Severe ascites. 2017-08-24T20:39:53Z The delivery system is a coaxial tube design. Boston Scientific Corporation The NIR stent was developed and is manufactured by Medinol Ltd. of Tel Aviv, Israel. Professionals . endobj PI-86716-AD 2017-08-16T13:11:22Z 74 0 obj <> Magnetic Resonance Imaging (MRI) Safety for Boston Scientific Peripheral Products The exterior tube is used to constrain the stent before deployment and reconstrain the stent, if stent repositioning is necessary, after partial deployment. Pacemakers and defibrillators that satisfactorily underwent All rights reserved. Biliary stent choice depends on cost, patient prognosis - Both plastic and metal stents used for symptom relief in patients with malignant biliary obstruction have limitations. Thursday, 07 January 2021 . 0000003479 00000 n 0000077680 00000 n The Epic Biliary Endoscopic Stent System is comprised of two components: the implantable stent and the stent delivery system. Animation. The safety and effectiveness of the stent for benign stricture treatment has not been established for indwell periods exceeding 12 months. The physician planned on removing these devices from the patient during a separate procedure on a later date. Advanix™ Biliary Stent with NaviFlex™ RX Delivery System. Eur Radiol 2009;19:2913-8. W. L. Gore & Associates, Inc. Migration Summary for GORE® VIABIL® Biliary Endoprosthesis and Boston Scientific WALLFLEX Biliary RX Fully Covered Stent. PI-86716-AF MRI Compatibility for PI Products h��Z�n�6��S�R*�?�H ŀ���(��v��B�iG�~\IN�G�[�G��%�Nl�M2k�&��!���|�����,��� e>�4t������;A�8q69�Ȑ��:�q69��P� g�� �~B~c�% pf�:K�5����&�3���~�A� @ܙ��x BH�g�_���;� �4/�kͽ�ϒv���GS�Qi 3931 Flexima Biliary Stent System provides external and internal percutaneous drainage of the biliary system. The WallFlex Stent is the most frequently implanted biliary metal stent worldwide. 0000174999 00000 n 0000193213 00000 n The Epic Biliary Endoscopic Stent System is indicated for the palliation of malignant neoplasms in the biliary tree. 0000004125 00000 n H�TP�n�0��[t��v `(��C���D;jJ���_Ipd y�#��h�E�?�M�G�q��3��`W�u&n]�f�d"w�qji�P�B���y���߿�g��l�� y����tK8!EP�4`q��×�d!��~ U�w���8m�5��R굹$�8��΃�h��wՈ��ᙗo��0s�X/F�Gx�M�!��� �5j Part # 3422 Exp 1/13. safe for use in a standard MRI machine. The Express SD Renal Stent should not migrate in this MR environment. 17 0 obj <> endobj The Boston Scientific ELUVIA™ Drug-Eluting Vascular Stent System is a medical device containing an ancillary medicinal substance, which provides a mechanical scaffold for vascular lumen support (the stent component) and a pharmacological agent (paclitaxel) targeted towards reducing the injury response that leads to restenosis after According to Boston Scientific compatible MRI cans. AW0010-EN3. 0000005204 00000 n The results found that the stent was MRI safe with artifact affecting imaging at the location of the stent. 0000033186 00000 n (10) Kaya MG, et al. Clinical safety of cardiac magnetic resonance imaging at 3 T early after stent placement for acute myocardial infarction. <> Eluvia PK results from Boston Scientific data on file. Expiration dates have mostly to do with sterilization and not the … October 6, 2009 - Boston Scientific Corp. announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its WallFlex Biliary RX fully and partially covered stents for the palliative treatment of malignant bile duct strictures. The Herculink Elite stent should not migrate in this MRI environment. Medical Specialties Reimbursement Education Investigator-Sponsored … 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 maintain luminal patency. Bench testing performed by Boston Scientific Corporation. Contraindications The WallFlex Biliary RX Partially Covered Stent System is contraindicated for: • Placement in biliary strictures caused by benign tumors, as the … Manufacturer: Bard Peripheral Vascular. 278485 The Express SD Renal Stent has been shown to be MR safe at field strength of 3 Tesla (T) or less, and a maximum whole body averaged specific absorption rate (SAR) of 2.0 W/kg for 15 minutes of MR imaging. 0000175247 00000 n The covered WallFlex™ Biliary RX Stent should not migrate in this Magnetic Resonance Imaging (MRI) environment, as magnetic force and torque in the non-clinical tests was less than the values exerted by the earth’s gravity. Top. Not for human use in the US. Only Express LD Iliac and Biliary Stent was engineered to provide the perfect balance of compression resistance and conformability—without trade-off. Data on file. While metallic stents have since been approved for specific cardiovascular Boston Scientific Corporation Customer Service: 888‐272‐1001 www.bostonscientific.com Page 1 of 12 PI‐86716‐AG Magnetic Resonance Imaging (MRI) Safety for The WallFlex Biliary RX Partially Covered Stent has a retrieval loop for removal during the initial stent placement procedure, to be used in Not for human use in the US. 0000011068 00000 n Express LD Iliac and Biliary Stent was engineered to provide the perfect balance of compression resistance and conformability—without trade-off. MRI compatibility of the embolic coils used in conjunction with the stent has not been demonstrated by Boston Scientific; refer to the specific embolic coil labeling for MRI … %%EOF 72 0 obj endobj endstream endobj 35 0 obj<> endobj 36 0 obj<>stream 36 0 obj The hypothesis we propose to test is whether metal stents as a primary procedure result in better patency rates, are more cost effective … Where available, MR safety information can be found on each product specification page on the Cook Medical website. On both the proximal and . AW0010-EN3. 0000193409 00000 n US MRI safety information - heart valve products. The FDA said today it is reclassifying Boston Scientific‘s (NYSE:BSX) WallFlex Biliary RX fully covered stent system to a Class II device.. In Perfect sealed condition but past expiration date. Explore … Temporary placement of a biliary stent as a treatment of biliary obstruction resulting from benign bile duct strictures. 0 0000002817 00000 n ... Valeo Balloon Expandable Biliary Stent . application/pdf The WallFlex Biliary RX Fully Covered Stent System RMV is for single-use only. 3e3e17480e6a94efad2b4f46258ee8eb6ddb8512 It is also available in models that deploy from the proximal or distal end. Pete Nicholas, Chairman and Chief Executive Officer of Boston Scientific, said, "The introduction of the NIR stent platform in the 0000006240 00000 n The patient … endstream [Literature Summary]. Express LD Stent System Directions for Use Patient Guide - Understanding Iliac Artery Disease Indications, Safety, and Warnings Sign-up for Product Updates Request a Sales Rep. Email Your Questions. <> 0000193707 00000 n Stent of a duct with total biliary occlusion which cannot be crossed by the delivery catheter. endstream endobj 18 0 obj<> endobj 19 0 obj<> endobj 20 0 obj<>/ColorSpace<>/Font<>/ProcSet[/PDF/Text/ImageC]/ExtGState<>>> endobj 21 0 obj<> endobj 22 0 obj<> endobj 23 0 obj<> endobj 24 0 obj<> endobj 25 0 obj<> endobj 26 0 obj<> endobj 27 0 obj<> endobj 28 0 obj<> endobj 29 0 obj<> endobj 30 0 obj<> endobj 31 0 obj[/ICCBased 48 0 R] endobj 32 0 obj<> endobj 33 0 obj<> endobj 34 0 obj<>stream Ltd. of Tel Aviv, Israel Advanix Biliary Duodenal Bend Biliary stent radiopaque... Of benign Biliary strictures U.S. for the treatment of benign Biliary strictures, MR Conditional these... Extended approximately 2mm from the proximal or distal end Safe, MR Conditional, and MR Unsafe to... T, Itoi T, Itoi T, Itoi T, Itoi,... 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Ends of the Biliary version of Boston Scientific has an exclusive worldwide boston scientific biliary stent mri safety to market and distribute the stent! Is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world not in! Stent image artifact extended approximately 2mm from the proximal end can be a good for! Warnings: the implantable stent and the stent for single-use only been established Epic should. Implantation of the stent to aid in placement - WallFlex™ Biliary ( 08714729759256 ) stent. All items listed are on inventory retrieval, Accessories, stent occlusion with resultant readmission to an ERCP centre.