NATICK, Mass. %��'/8�\��[b�����8��n %PDF-1.7 %���� Model #: 7233 Epic Biliary Endoscopic Stent Systems - 10mm x 80mm. The Wallstent Self-Expanding Stent has been engineered to combine a unique stent design with a minimal free cell area, and a highly flexible, intuitive delivery system. Hardbound MRI Textbook. and SAN FRANCISCO, Nov. 8, 2011 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) reports positive outcomes from the CABANA post-approval study of the Carotid WALLSTENT ® Monorail ® Endoprosthesis used in conjunction with its FilterWire EZ Embolic Protection System in routine clinical practice. Thursday, 07 January 2021 . About Boston Scientific . For Healthcare Professionals For specific information about a Boston Scientific product's MR safety status, please refer to the product's Instructions For Use or contact Boston Scientific Customer Service. Promus ELITE™ Everolimus-Eluting . MRI Safe: The Wallstent Venous Endoprosthesis has shown no deflection or torque in the area of maximum spatial gradient (450 gauss centimeter) of a 1.5 tesla MRI system under conditions that produced a Specific Absorption Rate (SAR) of 1.3 W/kg. $150.00. They continue to innovate in these areas and are extending their innovations into new geographies and high-growth adjacency markets. Below is an excerpt of Section 6.12 from the Directions for Use detailing the safety of performing MRI following the placement of a Promus ELITE™ Stent. Non-clinical testing and MRI simulations were performed to evaluate the entire family (i. Featured stories and the latest news on what it takes to advance science for life. An office chair was in the wrong place - at ANY time! ©2021 Boston Scientific Corporation or its affiliates. Designed for ease of placement, the WALLSTENT™ Endoprosthesis Stent allows reconstrainability with the stent deployed up to the limit marker band. 1,5T full body 3T full body. WALLSTENT and HALO are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. Materials and Methods . AccessGUDID - WALLSTENT™ BILIARY (08714729229872)- Endoscopic Biliary Endoprosthesis. Safety Topic / Subject ProMRI Implantable Cardioverter Defibrillator Systems (ICDs)(Biotronik): Exclusion Zone MRI at 3-T/128 MHz Information applies to the following: ICDs - Iforia 7 DX, Iforia 7 VR-T, Iforia 5 DX, Iforia . Refer to DFU sizing chart for more information. Stryker. Note: Boston Scientific is not responsible for the correct use of codes on submitted claims; this information does not constitute reimbursement or legal advice. Brand Name: WALLSTENT® Endoprosthesis Version or Model: H965403330 Commercial Distribution Status: In Commercial Distribution Catalog Number: H965403330 What MRI safety information does the labeling 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. A steel oxygen tank is never permitted inside of the MRI system room. 9. Exclusion zone. All rights reserved. Boston Scientific develops, manufactures and distributes a wide array of products to meet the needs of a health care professionals and patients globally. Section 6.11 Magnetic Resonance Imaging (MRI) Safety Information . IFuse Implant, L Implant including multiple implant configurations with 2 to 4 implants, SI-BONE, www.si-bone.comSI Bone, www.si-bone.com BOSTON SCIENTIFIC - GALWAY PLACEHIT¿ BILIARY WALLSTENT¿ STENT, CAROTID Back to Search Results Model Number H965SCH650750 Device Problems Stent … Skip to Main Content ; U.S. National Library of Medicine NLM Tools and Resources FDA UDI Home FDA Medical Devices Home Report a Device Problem (MedWatch) Device Recalls Device Safety Communications Home; About; News; Download; API; Help; Customer Support & FAQ; FDA Tools and … AccessGUDID - WALLSTENT™ RX BILIARY (08714729296874)- RX Biliary Endoprosthesis Stent System. GMDN Preferred Term Name GMDN Definition; Multiple peripheral artery stent, bare-metal WallFlex Biliary RX Stent Removability The fully covered stent is indicated for indwell up to 12 months after placement in benign biliary strictures secondary to chronic pancreatitis. WALLSTENT RX BILIARY-Uncovered Endoprosthesis stent system - 10mm x 100mm. Designed to provide excellent compression resistance, WALLSTENT™ Endoprosthesis Stent provides increased scaffolding for optimal lesion coverage. Note: Boston Scientific is not responsible for the correct use of codes on submitted claims; this information does not constitute reimbursement or legal advice. ©2021 Boston Scientific Corporation oder ihre Tochtergesellschaften. Safety Topics Info & Terminology Screening Form Product Testing Lectures Disclaimer About Dr. Shellock Priority Email Accidents An office chair was in the wrong place - at ANY time! The Wallstent Endoscopic Biliary endoprosthesis is premounted on the Unistep Plus delivery system (Boston Scientific, Minneapolis, MN). Boston Scientific, www.bostonscientific.com . Magnetic Resonance Imaging (MRI) Safety for Boston Scientific Peripheral Products PDF, 272.0 KB. See product information table for specific size availability. 1,5T full body. BOSTON SCIENTIFIC - GALWAY WALLSTENT® ENDOPROSTHESIS CATHETER, BILIARY, DIAGNOSTIC Back to Search Results Model Number H965403320 Device … Model #: 3294 Advanix Biliary Duodenal Bend - 8.5Fr x 7cm. Safety Topic / Subject Cortical bone screw small (titanium alloy) orthopedic implant Zimmer Warsaw, I. All other trademarks are the property of their respective owners. Promus PREMIER™ Everolimus-Eluting . Carotid WALLSTENT™ & WALLGRAFT™ Endoprostheses. BOSTON SCIENTIFIC WALLFLEX Biliary RX Fully Covered Stent with a high Af and low Rf straightens the bile duct anatomy, which increases the risk of migration . 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. Specific conditions. Migration Resistance Looped and flared stent ends Thursday, 07 January 2021 . $150.00. This advanced delivery system allows the endoscopist to resheath a partially deployed To evaluate stent lumen visibility of a large sample of different peripheral arterial (iliac, renal, carotid) stents using magnetic resonance angiography in vitro. MRI Safety Information. Note: Boston Scientific is not responsible for the correct use of codes on submitted claims; this information does not constitute reimbursement or legal advice. Brand Name: WALLSTENT BILIARY Version or Model: H965430800 Commercial Distribution Status: In Commercial Distribution Catalog Number: Company Name: BOSTON SCIENTIFIC CORPORATION What MRI safety information '�s�.��K ��9YY��� Q'ʮ�Pm�b���p'B� rn��S��|��kh�j���/�3 E�_w}v[�� �}�\�_�/Zu^�|���8�0s5���Ƅ�x �9AJp�e\;�����Y��p�.�3�?י�JQ�չ��gi:�E���\������,�r��>�~UOz�Hy0á ���ȍ�шo�H-�2��qB鬊K^�)m�Ξe�J����9����Y�DnGZ�6NE�Q�i8&������=�U�^�� Go��k��+]%�x���^���6�c�����r���*��;V)�����"�!�R|�0�P�Q��lj(E�H{��g�=�)]QG���T�}ZG�hoz�<0s�06���Vz�•�o��xG��8��Ť�^=�Hm_�O6V�a���kk�]�p5s���/����6�RQ䵔 "��(?q�V�?���*����My�.��_��̔P��Y�&. $40.00. Non‐clinical testing has demonstrated that WALLSTENT Transhepatic Biliary is MR Conditional for single and overlapping lengths up to 94 mm. It may be a mesh structure or a continuous tube and is made entirely of metal [e.g., high-grade stainless steel, cobalt-chrome (Co-Cr), nickel-titanium alloy (Nitinol)]. Boston Scientific Scimed has not marketed the Wallstent Venous Endoprosthesis for the central vein indication. BOSTON SCIENTIFIC - GALWAY WALLSTENT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM CATHETER, BILIARY, DIAGNOSTIC Back to Search Results Model Number H965404120 Boston Scientific Express LD iliac and Biliary - Independent Reviews by Clinicians for Clinicians. The safety and effectiveness of the WallFlex Biliary RX Stenting System for use in the vascular system have not been established. No exclusion zone. WALLSTENT RX BILIARY-Uncovered Endoprosthesis stent system - 10mm x 60mm. Wallflex Biliary RX Stents Prescriptive Information Refer to the device directions for use for complete instructions on device use. Boston Scientific. This advanced delivery system allows the endoscopist to resheath a partially deployed stent and to reposition either proximally or distally, if desired, after the deployment process is initiated. MRI Safety . In combinaison with Boston Scientific compatible MRI leads. Model #: C171590 ... DA: 2 PA: 61 MOZ Rank: 7 Boston Scientific, www.bostonscientific.com 1.5, 3 Conditional 5 More... Coils, Filters, Stents, and Grafts More... iForma orthopedic implant CONFORMIS, Inc. Lexington, MA … Platinum Chromium Coronary Stent System . Brand Name: WALLSTENT RX BILIARY Version or Model: M00569650 Commercial Distribution Status: In Commercial Distribution Catalog Number: Company Name: BOSTON SCIENTIFIC CORPORATION What MRI safety AccessGUDID - WALLSTENT™ RX BILIARY (08714729456711)- RX Biliary Endoprosthesis Stent System. TrelliX Embolic Coil System, All Versions Shape Memory Medical, Inc., www.shapemem.com MRI Safety Information Non-clinical testing and MRI simulations were performed to evaluate the entire family (i. The safety and effectiveness of the WallFlex Biliary RX Stenting System for use in the vascular system have not been established. For specific information about a Boston Scientific product's MR safety status, please refer to the product's Instructions. Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. 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 Sentinol system expands Boston Scientific's family of high-performance self-expanding biliary stents, which includes the WALLSTENT® Endoprosthesis and the Symphony® Biliary Stent. In 46 patients, a covered Wallstent was preceded by a plastic biliary stent (N = 21) or by a Please email info@medicalmaterials.com or call us at … The $150.00) OEM: Boston Scientific; Model #: 6981; Year: 2016 Size: 10mm x 100mm Current Stock: This item is out of stock. Anwendungsgebiete: Das Boston Scientific Neuromodulation … Disease stages were based on the findings of CT and EUS. About Boston Scientific Boston Scientific is a worldwide developer, manufacturer and marketer of Skip to Main Content ; U.S. National Library of Medicine NLM Tools and Resources FDA UDI Home FDA Medical Devices Home Report a Device Problem (MedWatch) Device Recalls Device Safety Communications Home; About; News; Download; API; Help; Customer Support & FAQ; FDA Tools and … Summary of Preclinical Studies 9.1 Biocompatibility The biocompatibility of the WALLSTENT Venous Intended Use/Indications for Use: The WallFlex Biliary RX Stents are indicated for use in the palliative ** Approximate implanted stent lengths. Listing a study does not mean it has been evaluated by the … Platinum Chromium Coronary Stent System . Trade name WALLSTENT 7F PLACEHIT, SELF-EXPANDABLE METAL STENT FOR BILIARY Product Code H965SCH6507X0 Manufacturer of the medical device BOSTON SCIENTIFIC CORPORATION Category Name Das Precision Montage™ MRI SCS-System bietet sicheren Zugang zu Ganzkörper-MRT-Scans, wenn es mit bestimmten Komponenten verwendet und unter den in den ImageReady MRT Ganzkörperrichtlinien für Precision Montage MRT Rückenmarksstimulatorsystem definierten Bedingungen der MRT-Umgebung ausgesetzt wird. C-codes are used for hospital outpatient device reporting for Medicare and some private payers. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Skip to Main Content ; U.S. National Library of Medicine NLM Tools and Resources FDA UDI Home FDA Medical Devices Home Report a Device Problem (MedWatch) Device Recalls Device Safety Communications Home; About; News; Download; API; Help; Customer Support & FAQ; FDA Tools and Resources FDA … BOSTON SCIENTIFIC - GALWAY WALLSTENT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM CATHETER, BILIARY, DIAGNOSTIC: Back to Search Results: Model Number UNK479: Device Problem Occlusion Within Device (1423) Patient Problem Reocclusion (1985) Event Date 01/29/2013: Event Type Injury Event Description Same case as mdr id# 2134265-2013-00966, 2134265-2013 … AccessGUDID - WALLSTENT® Endoprosthesis (08714729204053)- Self-Expanding Stent. Four radiopaque marker bands on the Unistep Plus delivery … AccessGUDID - WALLSTENT™ BILIARY (08714729204640)- Endoscopic Biliary Endoprosthesis. 1.5,3: Conditional 5 More... Coils, Filters, Stents, and Grafts More... De La Cruz Fluoroplastic, Platinum, Piston Otologic Implant Medtronic Xomed, Jacksonville, T. 3: Conditional 5 More... Otologic Implants More... Deck Scraper 45*300-mm Newmatic Medical, www.newmaticmedical.com . Purpose . According to Boston Scientific compatible MRI cans. Boston Scientific Launches Sentinol Self-Expanding Nitinol Biliary Stent System (April 8, 2004) -- Boston Scientific Corporation (NYSE: BSX) today announced the U.S. launch of its Sentinol™ Self-Expanding Nitinol Biliary Stent System (Sentinol), which has been cleared by the U.S. Food and Drug Administration for the treatment of malignant biliary obstruction. A patient with this stent can be scanned safely, immediately after placement, under the following conditions: RESONATE DAI (D432, D433) Field strength. Boston Scientific. Boston Scientific Corporation and Stryker Neurovascular, www.stryker.com . Facebook; Email; Print; Twitter; Pinterest; WALLSTENT RX BILIARY-Uncovered Endoprosthesis stent system - 10mm x 100mm Boston Scientific. Shape Memory Medical, Inc., www.shapemem.com. The Wallstent Endoscopic Biliary endoprosthesis is premounted on the Unistep Plus delivery system (Boston Scientific, Minneapolis, MN). Safety Topic / Subject TrelliX Embolic Coil System, All Versions. 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. 880 MRI AccessGUDID - WALLSTENT™ BILIARY (08714729204664)- Endoscopic Biliary Endoprosthesis. Magnetic Resonance Imaging (MRI) Safety for Boston Scientific Peripheral Products PDF, 272.0 KB Top *Please note that reconstrainment and repositioning are subject to specific limitation. Boston Scientific Boston Scientific’s products and technologies are used to diagnose or treat a wide range of medical conditions, including heart, digestive, pulmonary, vascular, urological, women’s health, and chronic pain conditions. does not constitute reimbursement or legal advice. Boston Scientific Carotid WALLSTENT® Found Safe in Study of High Surgical Risk Patients in Routine Clinical Practice. Skip to Main Content ; U.S. National Library of Medicine NLM Tools and Resources FDA UDI Home FDA Medical Devices Home Report a Device Problem (MedWatch) Device Recalls Device Safety Communications Home; About; News; Download; API; Help; Customer Support & FAQ; FDA Tools and Resources FDA … – BOSTON SCIENTIFIC WALLSTENT Endoprosthesis: 13.3% (4/30) – 3 peritoneal irritation, 1 self limited biliary hemorrhage Conclusions “In conclusion, Viabil [GORE ® VIABIL Biliary Endoprosthesis] stents have been shown to be safe for palliation of malignant MRI Safety . RESONATE IS1 CRTD (G424) Field strength. BOSTON SCIENTIFIC - GALWAY WALLSTENT RX BILIARY ENDOPROSTHESIS, MODELS 6961-6972 INCLUSIVE CATHETER, BILIARY, DIAGNOSTIC Back to Search Results Model Number UNK384 Last update. Safety Topic / Subject Double Open Ended Wrench 18*19-mm Newmatic Medical, www.newmaticmedical.com . 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. Indications:  1 = Tracheobronchial, 2 = Transjugular Intrahepatic Portosystemic Shunt (TIPS), 3 = Transhepatic Biliary, 4 = Iliac, 5 = Venous, Fully open dimensions:  to determine implanted length, refer to Box Label. •|=gTO^���H��I��H�(x��Z�l�g�v����P�>�姫��4=1��T���$a�̀���ơ;���h�l�[�ba��O����3�I�ٱ�.�H �U�J������*W��9])r��`�]]�i?�u��ۅP���>A�K�p�� #�x��?����Օ���\�(�c�������yBj�d���DH�t�Pp��< QU���8���b�YB������1�'澨3I4y̯�� /�S�3f�LD���4��T�q-w4k�X�I�T�w��. Below is an excerpt of Section 6.11 from the Directions for Use detailing the safety of performing MRI following the placement of a Promus PREMIER Stent. The delivery system is braided and offers excellent trackability and pushability Boston Scientific’s products and technologies are used to diagnose or treat a wide range of medical conditions, including heart, digestive, pulmonary, vascular, urological, women’s health, and chronic pain conditions. Boston Scientific widmet sich der Transformation von Leben durch innovative medizinische Lösungen, die die Gesundheit der Patienten auf der ganzen Welt verbessert. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Boston Scientific Placehit Biliary Wallstent - Independent Reviews by Clinicians for Clinicians. INDICATIONS: Tracheobronchial: 5–24 mm stents; Transhepatic Biliary: 8–12 mm stents; TIPS: 10–12 mm stents; Central Venous: 10–16 mm stents Fully Open Dimensions (as labeled on box) Approximate Implanted Stent Length Sheath Compatability Diameter* x Length (mm) Lumen Diameter (mm) Stent Length (mm) Lumen Diameter (mm) Stent … Cardiac Resynchronization Therapy (CRT) Devices, Transcatheter Aortic Valve Replacement (TAVR), Medical Device ID Cards - Pacemaker, ICD, & CRT devices, Remote Patient Monitoring and Diagnostic Monitoring, Boston Scientific Peripheral Interventions Product Catalog, ADVANTICS™ Innovative Healthcare Solutions. Brand Name: WALLSTENT BILIARY Version or Model: H965430200 Commercial Distribution Status: In Commercial Distribution Catalog Number: Company Name: BOSTON SCIENTIFIC CORPORATION What MRI safety information Floor polishers are poor MRI system cleaners! Wallstent Endoprosthesis Magic Wallstent 3.5 x 25 coil, stent, filter Schneider (USA) Inc. Pfizer Medical Technology Group Minneapolis, M Magnetic Resonance Imaging (MRI) Safety for Boston Scientific Products ... Non‐clinical testing has demonstrated that WALLSTENT™ Transhepatic Biliary is MR Conditional for single and overlapping lengths up to 94 mm. More ... 1.5, 3: Conditional 8 More... Coils, Filters, Stents, and Grafts More... 2D Helical, 35 Fibered Platinum Coil. 3136 0 obj <>stream Take action in addressing health inequities in your community. The C-code used for this product is C1876, Stent, non-coated/non-covered with delivery system. Double Open Ended Wrench 5.5*7-mm Newmatic Medical, www.newmaticmedical.com . The covered Wallstent was inserted after unresectability was confirmed. *Available sizes vary per indication. 1.5: Safe More... Orthopedic Implants, Materials, and Devices More... corVCD (implant for vessel coupling) corLife GBR, www.corlife.eu. It was reported to boston scientific corporation that two wallstent biliary endoprostheses were implanted during an endoscopic retrograde cholangiopancreatography (ercp) procedure on (b)(6) 2010 as part of a post market study. tИ�@q��0��!�\�����M�Nk [�X�Rz;��S� dc�>@< The EGIS range of biliary stents from S&G Biotech provides a comprehensive and quality offering to the Interventional Radiologist and Endoscopist. endstream endobj 3137 0 obj <>stream NATICK, Mass. Boston Scienti˜c, (Master Brand DFU Template 8.2677in x 11.6929in A4, 92238519A), eDFU, MB, VENOUS WALLSTENT, en 50607601-01B Black (K) ˚E ˛5.0 VENOUS WALLSTENT Self-Expanding Stent 2020-03 < … Double Open-end wrench WO-17X19 Ampco Safety … Intended to provide increased scaffolding for optimal lesion coverage, Designed to promote excellent angiographic results, Engineered to provide a smooth inner lumen, Reconstrainable* when deployed up to the limit marker band, Exceptional stent radiopacity intended to provide excellent angiographic visibility for precise positioning, Radiopaque markers on the inner shaft and retractable outer sheath are designed to aid in stent positioning, Note: Boston Scientific is not responsible for the correct use of codes on submitted claims; this information. Last update . Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x7cm, Material Number M00539210: Code Information : Lot 22960201: Recalling Firm/ Manufacturer: Boston Scientific Corporation 300 Boston Scientific Way Marlborough MA 01752-1291: For Additional Information Contact: Nicole Pshon 763-494-1133 Manufacturer Reason for Recall: The sterile barrier may contain packaging … EMBLEM™ MRI S-ICD System; Spinal Cord Stimulation; Transcatheter Aortic Valve Replacement (TAVR) WATCHMAN™ Implant; All Procedures & Treatments; Patient Support; Patient and Caregiver Support; Find A Heart Specialist; Traveling with LATITUDE; Medical Device ID Cards - Pacemaker, ICD, & CRT devices; Find a TheraSphere Treatment Center Increased scaffolding for optimal lesion coverage family of high-performance self-expanding Biliary stents from S & G Biotech a... Is MR Conditional for single and overlapping lengths up to 94 mm is premounted on the Unistep Plus delivery (... Rx Biliary Endoprosthesis evaluate the entire family ( i, Minneapolis, MN ) Wrench 18 * Newmatic! Biliary RX Stenting system for use in the vascular system have not been.! Scientific, Minneapolis, MN ) and quality offering to the Interventional and. Neuromodulation … Carotid WALLSTENT™ & WALLGRAFT™ Endoprostheses for single and overlapping lengths up 94. Biliary - Independent Reviews by Clinicians for Clinicians into new geographies and high-growth markets! Stent system - 10mm x 80mm around the world health of patients around world. Stenting system for use in the vascular system have not been established Medical www.newmaticmedical.com... Marketed the Wallstent Venous Endoprosthesis for the central vein indication WALLSTENT™ Biliary ( 08714729456711 ) - RX Biliary is... Effectiveness of the WallFlex Biliary RX Stenting system for use in the vascular system have not been.... 08714729204053 ) - self-expanding Stent Wallstent and HALO are registered or unregistered trademarks of Boston Scientific Peripheral Products PDF 272.0. Into new geographies and high-growth adjacency markets of the MRI system room expands Boston Scientific Scimed has marketed! Wallstent RX BILIARY-Uncovered Endoprosthesis Stent system - 10mm x 80mm for use in the vascular system have not been.! Vascular system have not been established of their respective owners never permitted inside of the MRI room... Are registered or unregistered trademarks of Boston Scientific Scimed has not marketed the Wallstent Endoscopic Endoprosthesis... Mri system room Corporation or its affiliates Wallstent was inserted after unresectability was.... Outpatient device reporting for Medicare and some private payers * 19-mm Newmatic,. 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Entire family ( i non-coated/non-covered with delivery system Das Boston Scientific Neuromodulation … Carotid WALLSTENT™ & WALLGRAFT™ Endoprostheses the! Demonstrated that Wallstent Transhepatic Biliary is MR Conditional for single and overlapping lengths up to mm! A wide array of Products to meet the needs of a health care professionals and patients.... Wallgraft™ Endoprostheses Epic Biliary Endoscopic Stent Systems - 10mm x 80mm transforming lives through innovative Medical solutions improve. Permitted inside of the MRI system room provide excellent compression resistance, WALLSTENT™ Endoprosthesis Stent..