boston scientific biliary stent mri safety

The delivery system is a coaxial tube design. Liberte' (Liberte) Coronary Stent Liberte Bare-Metal Coronary Stent Boston Scientific, www.bostonscientific.com ... Valeo Balloon Expandable Biliary Stent . safe for use in a standard MRI machine. 0000011068 00000 n The Herculink Elite stent should not migrate in this MRI environment. 2017-08-16T13:11:22Z 1.5,3: Safe More... Coils, Filters, Stents, and Grafts More... Polaris Ultra Dual Durometer Ureteral Stent Boston Scientific Corporation www.bostonscientific.com. Stent occlusion with resultant readmission to an ERCP accredited centre obviously compounds this problem. BRIEF STATEMENT. ����[�h���u��0T:�!���I��73�C�B� iQE`��)qF � �$B�!t*�� ��U%�[9 �G~C͍$�dN��rۓ\�yq��{���+[W�ZL=��Ou�j�����۶�R8�J#@ګ:Ύ��R�t������ѫ"�'uR�Q�k��m��[�aC�kU�/S����V��SQ>ם��\܊2�V+�~Ks�'ꍧ"_�7�~���]6T��^, Magnetic Resonance Imaging (MRI) Safety for Boston Scientific Peripheral Products, PI-86716-AE AUG2015 stents magnetic resonance imaging MRI compatibility, PI-86716-AF MRI Compatibility for PI Products. 0000033438 00000 n Thursday, 07 January 2021 . <]>> In Perfect sealed condition but past expiration date. 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. H�TP=o� ��[u��*u���뒡j��89��C���B.J����g?��ۗ6�����0���#��BႣ 8o�h'��q���6���ϒ�3�p��R>�{���|�����-)���!� ������դ73!���ׄ�6,���ᜌE2aDh�']�ӓҀ���3uS]{5Ďj�,4�E����ݫj���a�.D��v��V5��J1����_ ��m� endstream PI-86716-AF MRI Compatibility for PI Products Severe ascites. The Epic Biliary Endoscopic Stent System is comprised of two components: the implantable stent and the stent delivery system. 0000005204 00000 n <> Isayama H, Mukai T, Itoi T, et al. 0000033186 00000 n The WallFlex Biliary RX Uncovered Stent System is provided sterile using ethylene oxide and is a single use device. Device Description The WallFlex Biliary RX Fully Covered Stent System RMV consists of a flexible delivery system preloaded with a self-expanding biliary metal stent. Advanix™ Biliary Stent with NaviFlex™ RX Delivery System. 0000005480 00000 n endobj Contraindications The WallFlex Biliary RX Partially Covered Stent System is contraindicated for: • Placement in biliary strictures caused by benign tumors, as the … 7F x 9 cm. It was reported to boston scientific corporation that a wallflex biliary fully covered rmv stent was to be implanted to treat a benign and malignant strictures in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on an unknown date. The WallFlex Biliary RX Partially Covered Stent System is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms and relief of malignant biliary obstruction prior to surgery. 0000005987 00000 n Thursday, 07 January 2021 . Boston Scientific 3422 Advanix Biliary Stent w Naviflex RX Delivery System is designed to maximize flow rates, improve pushability through tortuous anatomy, and be repositionable to aid in accurate placement. Coron Artery Dis 2009; 20:138-42. Warnings: The safety and effectiveness of the stent has not been established for indwell periods exceeding 12 months. Stent of a duct with total biliary occlusion which cannot be crossed by the delivery catheter. (9) Jehl J, et al. The Epic Stent should not migrate in this MRI environment. Temporary placement of a biliary stent as a treatment of biliary obstruction resulting from benign bile duct strictures. trailer The NIR stent was developed and is manufactured by Medinol Ltd. of Tel Aviv, Israel. Boston Scientific 3422 Advanix Biliary Stent w Naviflex RX Delivery System is designed to maximize flow rates, improve pushability through tortuous anatomy, and be repositionable to aid in accurate placement. 0000001697 00000 n RESONATE IS1 CRTD (G424) Field strength. 0000003197 00000 n Flagstaff, AZ: W. L. Gore & Associates, Inc; 2017. 0000015989 00000 n biliary applications, e.g., vascular restenosis, stent fracture if placed across a joint, and long-term fatigue testing. 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 … Formula 418 RX … Boston Scientific Corporation 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. 0000077245 00000 n No exclusion zone. Not for human use in the US. uuid:25e82b54-76d6-4425-96a5-e3733fe0351f Professionals . N=3. 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 MRI Compatibility for PI Products $599.00 box of 1 - Boston Scientific # M00570370 - Boston Scientific WallFlex RX Fully Covered Biliary Stent: 10mm x 60mm AccessGUDID - WallFlex™ Biliary (08714729759256)- Stent System. Designed for ease of placement, the WALLSTENT™ Endoprosthesis Stent allows reconstrainability with the stent deployed up to the limit marker band. It was reported that the procedure lasted 3 hours, and that the patient was under anesthesia longer than anticipated. While metallic stents have since been approved for specific cardiovascular The WallFlex Biliary RX Stent is 510(k) cleared for the treatment of biliary strictures produced by malignant neoplasms and relief of malignant biliary obstruction prior to surgery. In Perfect sealed condition but past expiration date. PI-86716-AF MRI Compatibility for PI Products x�b```f``�a`c`�[email protected] !V�(��s��1`&**[D�K2ޭ���e�jpa��� �BB�ƭ���iW�� ����� i v�& �f`��H��>XD�A�����A��p��'3�7�3�� �c���'�L�8xX71K3�1,o�}` �AS�M�����k�sxXn�S���pM��� �@���={�.�a`��������WIiF ~` l�Ee 0000006785 00000 n Magnetic Resonance Imaging (MRI) Safety for Boston Scientific Peripheral Products MR imaging at 3 T or less may be performed The WallFlex Biliary RX Fully Covered Stent is not approved in the U.S. for the treatment of benign biliary strictures. Only Express LD Iliac and Biliary Stent was engineered to provide the perfect balance of compression resistance and conformability—without trade-off. Express LD Iliac and Biliary Stent was engineered to provide the perfect balance of compression resistance and conformability—without trade-off. 0000077680 00000 n H��V�n�@}�W�����/R�I������$.5� 0000006240 00000 n 2017-08-24T21:31:44Z PScript5.dll Version 5.2.2 GMDN Preferred Term Name GMDN Definition; 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. <> MR image quality may be compromised if the area of interest is in the same area or relatively close to the position of the device. "The WallFlex Biliary RX Stent leverages existing Boston Scientific technologies, while advancing … <> Magnetic Resonance Imaging (MRI) Safety for Boston Scientific Peripheral Products Protege GPS Nitinol Biliary Stent System. <> xref 0000033624 00000 n 0000001276 00000 n 75 0 obj Pete Nicholas, Chairman and Chief Executive Officer of Boston Scientific, said, "The introduction of the NIR stent platform in the The results found that the stent was MRI safe with artifact affecting imaging at the location of the stent. Clinical safety of cardiac magnetic resonance imaging at 3 T early after stent placement for acute myocardial infarction. "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. %%EOF Nexus Embolization Coil Nexus X-10-20-T10-TC Platinum-Iridium, Nitinol Micro Therapeutics, Inc. Irvine, CA It is a mesh structure made of metal which is covered/lined with a synthetic polymer material (e.g., silicone) that prevents lateral flow and tissue ingrowth and facilitates removability. 36 0 obj Pacemakers and defibrillators that satisfactorily underwent All rights reserved. The WallFlex Biliary RX Partially Covered Stent has a retrieval loop for removal during the initial stent placement procedure, to be used in The physician placed a cook plastic biliary stent. 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. The three categories of MR safety marking are: MR Safe, MR Conditional, and MR Unsafe. 0000193213 00000 n Express SD, RX Herculink Plus, Herculink Elite, PALMAZ Blue and Racer stents tested: 6 x 18 mm. After the procedure, the patient was transferred back to the icu still under sedation. Magnetic Resonance Imaging (MRI) Safety for Boston Scientific Peripheral Products PDF, 272.0 KB. uuid:3f5aa78a-66d5-4388-b6af-c09c072cc194 eIFU_Herculink_Elite.pdf A patient with the VICI VENOUS STENT can be scanned safely, immediately after placement, in an MR system meeting the following conditions: • Static magnetic field of 1.5 T or 3.0 T only. The Epic Biliary Endoscopic Stent System was developed to complement our best-in-class braided metal stent portfolio. Deliver the same, trusted Protégé EverFlex stent with the ease of single handed deployment when choosing the EverFlex self-expanding peripheral stent with Entrust delivery system to treat PAD in the SFA, proximal popliteal, subclavian, and common or external iliac arteries. 72 0 obj 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. Store at … [Literature Summary]. endobj 0000003996 00000 n Acrobat Distiller 10.1.16 (Windows) 0000192952 00000 n Boston Scientific 3422 Advanix Biliary Stent w Naviflex RX Delivery System. Acrobat Distiller 10.1.16 (Windows) The Express SD Renal Stent should not migrate in this MR environment. The safety and effectiveness of the stent for use in the vascular system have not been established. Contact technical support. 0000001876 00000 n Eur Radiol 2009;19:2913-8. 65 0 obj<>stream Part # 3422 Exp 1/13. ... MRI scanners, US Scanners; Cardio-thoracic. The Epic Biliary Endoscopic Stent System is indicated for the palliation of malignant neoplasms in the biliary tree. The patient … <> null endobj Outside the US MRI safety information - heart valve products. 0000012528 00000 n 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. The safety and effectiveness of the WallFlex Biliary RX Fully Covered Stent System RMV for use in the vascular system has not been established. 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 The physician planned on removing these devices from the patient during a separate procedure on a later date. 0000007088 00000 n 0000193409 00000 n In Stock! 32 0 obj 0000010364 00000 n Long-term clinical effects of magnetic resonance imaging in patients with coronary artery stent implantation. Expiration dates have mostly to do with sterilization and not the … US MRI safety information - heart valve products. 0000108315 00000 n According to Boston Scientific compatible MRI cans. 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. Animation. NATICK, Mass., March 22, 2012 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) announces the U.S. and international launch of the WallFlex ® Biliary Transhepatic Stent System. However, after … The hypothesis we propose to test is whether metal stents as a primary procedure result in better patency rates, are more cost effective … startxref Precautions. 76 0 obj 0 It is also available in models that deploy from the proximal or distal end. The WallFlex Biliary RX Stent is 510(k) cleared for the treatment of biliary strictures produced by malignant neoplasms and relief of malignant biliary obstruction prior to surgery. On both the proximal and . 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 … Comparison of partially covered nitinol stents with partially covered stainless stents as a … Where available, MR safety information can be found on each product specification page on the Cook Medical website. [Literature Summary]. <> The WallFlex Biliary RX Fully Covered Stent System RMV is for single-use only. 0000002817 00000 n Boston Scientific Corp. (NYSE:BSX) enrolled the first patient in a clinical trial of its WallFlex biliary stent for the treatment of benign bile duct strictures. 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. Explore … AW0010-EN3. Patients with bleeding disorders. In Spin Echo and Gradient Echo sequence evaluations Neuroform stent image artifact extended approximately 2mm from the device. Cook Medical Zilver Stent - Independent Reviews by … 0000013320 00000 n This device is the biliary version of Boston Scientific's Wallstent. endobj 17 49 0000004835 00000 n 0000193707 00000 n 2017-08-24T20:54:34Z middlett 0000006861 00000 n The stent is a laser cut self-expanding stent composed of a nickel titanium alloy (nitinol). Cost-effectiveness, safety and patient prognosis should guide stent selection. Last update . BOSTON SCIENTIFIC 3287 Advanix Biliary Duodenal Bend Biliary Stent, 7F x 5cm (X) All items listed are on inventory. In this system, “MR Safe” and “MR Unsafe” are the two extremes. The WallFlex Stent is the most frequently implanted biliary metal stent worldwide. Data on file. a�DVv0i��];�����f�םCvB��s�.4�v?�a�{ k����`��X� Stenting of a perforated duct where leakage from the duct could be exacerbated by the prosthesis. 0000003479 00000 n 0000007958 00000 n W. L. Gore & Associates, Inc. Migration Summary for GORE® VIABIL® Biliary Endoprosthesis and Boston Scientific WALLFLEX Biliary RX Fully Covered Stent. ��J�S����ڎ[email protected]��ؙ33g����Ø�Y�g�I�1DQ6�(��!�`1�17HXlP��N.j�&�w ���x*P6�RgJ����.��g V��"�&�fc��/�. application/pdf 0000000016 00000 n Deployment from the proximal end can be a good choice for proximal esophageal lesions. Description. 17 0 obj <> endobj %PDF-1.5 %���� 0000002473 00000 n <>stream 0000002120 00000 n <>stream conventional spin echo pulse sequence. 3931 Flexima Biliary Stent System provides external and internal percutaneous drainage of the biliary system. 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. 3931 Flexima Biliary Stent | Boston Scientific. endobj Eluvia PK results from Boston Scientific data on file. Boston Scientific has an exclusive worldwide license to market and distribute the NIR stent. The FDA said today it is reclassifying Boston Scientific‘s (NYSE:BSX) WallFlex Biliary RX fully covered stent system to a Class II device.. 2017-08-24T20:39:53Z Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. (10) Kaya MG, et al. Bench testing performed by Boston Scientific Corporation. 0000008721 00000 n Specific conditions. %PDF-1.4 %���� 147 0 obj The WallFlex Stent is not approved in the United States for use in the treatment of benign biliary strictures. Key Resources. The safety and effectiveness of this device for use in the vascular system have not been established. AW0010-EN3. 0000011725 00000 n 0000005701 00000 n Indications, Safety and Warnings for Express™ LD Iliac and Biliary Stent System This stent has not been evaluated to determine if it is MR Conditional beyond these conditions. The purpose of this study is to evaluate the safety and performance of the WallFlex® Biliary RX Fully Covered Stent as a treatment of biliary obstruction resulting from benign bile duct strictures. The WallFlex Stent is the most frequently implanted biliary metal stent worldwide. endstream endobj 35 0 obj<> endobj 36 0 obj<>stream 2017-08-24T21:31:44Z It may be used to palliate strictures caused by unresectable Bile Duct Cholangiocarcinoma. Ships Today! <> MRI at 3T or 1.5T may be performed immediately following the implantation of the Epic Stent. 0000009550 00000 n Duodenal Bend Preloaded. The system is available in 150cm shaft length… Biliary RX Partially Covered Stent is offered partially covered with Permalume™ Coating, a translucent silicone polymer, to reduce the potential for tumor ingrowth through the stent (Figure 1). 3e3e17480e6a94efad2b4f46258ee8eb6ddb8512 MR imaging within these conditions may be performed immediately following the implantation of the stent. 1,5T full body 3T full body. Foreign body retrieval, Accessories, Part # 3931 Exp 8/12. Not for human use in the US. GMDN Preferred Term Name GMDN Definition; Bare-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. 35 0 obj 0000004699 00000 n Flagstaff, AZ: W. L. Gore & Associates, Inc; 2017. 0000077491 00000 n 0000001617 00000 n endstream endobj 37 0 obj<> endobj 38 0 obj<> endobj 39 0 obj<> endobj 40 0 obj<>stream 1,5T full … 0000004125 00000 n 0000006538 00000 n The Neuroform Stent should not migrate in this MRI environment. PI-86716-AD 74 0 obj According to the complainant, during the procedure, the stent failed to deploy. distal ends of the stent, radiopaque markers increase visibility of the stent to aid in placement. RESONATE DAI (D432, D433) Field strength. Manufacturer: Bard Peripheral Vascular. The system's low profile (5Fr), triaxial design reduces friction during deployment, which allows for increased accuracy and more predictable stent placement. The Advanix Biliary Stent with NaviFlex RX Delivery System is designed to maximize flow rates, improve pushability through tortuous anatomy, and be … Exclusion zone. 0000175247 00000 n In combinaison with Boston Scientific compatible MRI leads. Boston Scientific at UEGW EMBLEM™ MRI S-ICD System; GreenLight™ Laser Therapy; Mid-Urethral Sling Procedure; Spinal Cord Stimulation; WATCHMAN™ Implant; How TAVR Devices Work - Transcatheter Aortic Valve Replacement (TAVR) All Procedures & Treatments; Patient Support; Patient and Caregiver Support; Find A Heart Specialist; Traveling with LATITUDE 0000216772 00000 n The safety and effectiveness of the stent for benign stricture treatment has not been established for indwell periods exceeding 12 months. Boston Scientific Corporation Customer Service: 888‐272‐1001 www.bostonscientific.com Page 1 of 12 PI‐86716‐AG Magnetic Resonance Imaging (MRI) Safety for PI-86716-AE AUG2015 stents magnetic resonance imaging MRI compatibility 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. endobj 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. Safety Topic / Subject Polaris Ultra Ureteral Stent Boston Scientific Corporation www.bostonscientific.com. 0000174999 00000 n Isayama H, Mukai T, Itoi T, et al. 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 0000003345 00000 n endobj Top. The exterior tube is used to constrain the stent before deployment and reconstrain the stent, if stent repositioning is necessary, after partial deployment. Stent Recoil defined as the change in stent diameter from nominally pressurized catheter to non-pressurized catheter condition in 37° C water, as measured by a magnified vision system. 79 0 obj 0000059174 00000 n 278485 Safety Topic / Subject Polaris Ultra Ureteral Stent Boston Scientific Corporation www.bostonscientific.com ... Coils, Filters, Stents, and Grafts More... Polaris Ultra Dual Durometer Ureteral Stent Boston Scientific Corporation www.bostonscientific.com. It was reported to boston scientific corporation that a wallflex biliary rx covered stent was to be implanted to treat a stenosis in the common bile duct during a stenting procedure performed on (b)(6) 2020. W. L. Gore & Associates, Inc. Migration Summary for GORE® VIABIL® Biliary Endoprosthesis and Boston Scientific WALLFLEX Biliary RX Fully Covered Stent. 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. endobj 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 Last update. 0000005238 00000 n

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