It is made entirely of a synthetic polymer(s) [e.g., polytetrafluoroethylene (PTFE), polyethylene (PE), silicone] and may have various designs (e.g., continuous tube with or without drainage side holes, covered or non-covered mesh structure). Reproduced with Permission from the GMDN Agency. Boston Scientific Announces FDA Clearance and CE Mark Approval for Advanix™ Biliary Stents Latest innovation in plastic biliary stent technology includes features for enhanced deliverability, efficiency and procedural control About Boston Scientific MRI Safety Information. Boston Scientific Announces FDA Clearance and CE Mark Approval for Advanix™ Biliary Stents Latest innovation in plastic biliary stent technology includes features for enhanced deliverability, efficiency and procedural control Boston Scientific Corporation has demonstrated that the proposed AdvaniXTM Biliary Stent with NaviFleXTm RX Delivery System is substantially equivalent to Boston Scientific Corporation's … 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. MR imaging within these conditions may be performed immediately following the implantation of the stent. endstream
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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. The Endoscopy Channel provides educational videos for physicians delivered by physicians. A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. Dental Implants, Devices, and Materials More... ALIMAXX-B Covered Biliary Stent 10-mm x 80-mm Nickel Titanium with a silicone covering Alveolus, Inc. Charlotte, NC. ... Coils, Filters, Stents, and Grafts More... 2D Helical, 35 Fibered Platinum Coil. Nexus Embolization Coil Nexus X-10-20-T10-TC Platinum-Iridium, Nitinol Micro Therapeutics, Inc. Irvine, CA We understand that you need dependable advanced stent technologies optimized for patient care. 0000003412 00000 n
A steel oxygen tank is never permitted inside of the MRI system room. $40.00) OEM: Boston Scientific; Model #: 3735; Year: 2016 Size: 4Fr x ... Advanix™ Center Bend Biliary Stent-w-NaviFlex™ RX Delivery System - 10Fr x 5cm $40.00. 0000002593 00000 n
Food and Drug Administration Staff . WALLFLEX Biliary RX Fully Covered Stent Electro-polished Nitinol stent Moderate radial force and low axial force, which prevents compression and migration Reported migrations ranging from 0–1 .4% compared to migration rates up to 13% for the BOSTON SCIENTIFIC WALLFLEX Biliary RX Fully Covered Stent A durable, nonporous ePTFE/FEP end-to-end liner Floor polishers are poor MRI system cleaners! �`a�b�i`� 2�"ȾHb����? Stenting in a post-operative biliary fistula or leak Multi-stenting in an anastomotic stricture post orthotopic liver transplant Boston Scientific Announces FDA Clearance and CE Mark Approval for Advanix™ Biliary Stents Latest innovation in plastic biliary stent technology includes features for enhanced deliverability, efficiency and procedural control 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. 0000003307 00000 n
Boston Scientific Corporation ... Oct 21, 2010. 0000002030 00000 n
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Boston Scientific 3226 Advanix Biliary Double Pigtail Biliary Stnt 10Fr x 5 cm Item Past Expiration. An office chair was in the wrong place - at ANY time! 138 0 obj<>stream
Bostonscientific.com Contact Us Disclaimer. ... Get Email Updates Top. 0000032705 00000 n
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Biliary RX Stents Fully covered stent is designed for removal up to 12 months post-placement. 0000005619 00000 n
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Company Name: BOSTON SCIENTIFIC CORPORATION. TrelliX Embolic Coil System, All Versions. The WallFlex Biliary RX Fully Covered Stent System RMV is currently the only biliary metal stent in the U.S. for indwell up to 12 months in the treatment of benign biliary strictures secondary to chronic pancreatitis. Endoscopically-placed stents are a clinically effective treatment for biliary In Stock! Bostonscientific.com The Advanix Biliary Stent with NaviFlex RX Delivery System is designed to maximize flow rates, improve pushability through tortuous anatomy, and be repositionable to aid in accurate placement. It was reported to boston scientific corporation that an advanix preloaded biliary stent was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the common bile duct (cbd) performed on (b)(6) 2013. MR imaging within these conditions may be performed immediately following the implantation of the stent. GMDN Names and Definitions: © Copyright GMDN Agency 2015. Advanix™ Pancreatic Stent Kit/ Single pigtail Stent-NO leading Barb - 4Fr x 3cm Boston Scientific. Established soft knitted, flexible stent available in proximal release which can aid in stent placement in proximal strictures of the esophagus WallFlex TM Esophageal Stent (partially covered) Seeks to deliver luminal patency through flexibility and control designed to traverse tight strictures. Ships Today! 0000006359 00000 n
AccessGUDID - Advanix™ Biliary (08714729787013)- Biliary Stent. The safety and effectiveness of the WallFlex Biliary RX Stent System for use in the vascular system have not been established. Covered WallFlex Biliary RX Stent Boston Scientific, www.bostonscientific.com. %%EOF
MR imaging within these conditions may be performed immediately following the implantation of the stent. Brand Name: Advanix™ Biliary. 0000001584 00000 n
You need a trusted partner with over 20 years of investment in clinical research and development and a commitment to the highest standards of quality. 0000005940 00000 n
Description. The Advanix Biliary Stent and NaviFlex RX Delivery System are available in a variety of sizes and shapes to accommodate both malignant and benign biliary strictures, distinct patient anatomies and physician preferences. GMDN Preferred Term Name GMDN Definition; Polymeric biliary stent, non-bioabsorbable 0000020391 00000 n
For products available in other countries, please choose one of our other websites from the region selector at the top of the site or contact your local Cook Medical representative. NaviFlex™ RX Delivery System includes an ergonomic handle lock to adjust guide catheter length. Proposed Device: Trade Name: AdvaniXTm Biliary Stent with NaviFleXTm RX Delivery System Classification Name: Stents, drains and dilators for the biliary ducts - Product Code FGE: Product: Advanix Pancreatic Stent, Straight Leading Barb, 10F x 6cm UPN: M00536640: Code Information: Lot Codes: 21973220 22522254 23837823 Recalling Firm/ Manufacturer: Boston Scientific Corporation 300 Boston Scientific Way Marlborough MA 01752-1291 $20.00 each - Boston Scientific # M00534210 - Boston Scientific Advanix Duodenal Bend Pre-loaded Rx Biliary Stent: 7F x 7cm Boston Scientific, www.bostonscientific.com . Boston Scientific has received 510(k) clearance and CE Marking for its Advanix biliary plastic stent. Global Unique Device ID: 08714729787402. H��W[�%�~�_��fLF����^&ƻ�I��İ��I6���������Zj���K��N�w�~������?����߳��k��_<=�5Z��������oK��rdO�&���]�L��,����o/$�_��o����t����BM���=�n�]�o��D����Ż�b���e�. al., “Plastic biliary stent occlusion: factors involved and possible preventative approaches.” Clinical Medicine and Research, 2007; 5(1); 53-60. Liberte' (Liberte) Coronary Stent Liberte Bare-Metal Coronary Stent Boston Scientific, www.bostonscientific.com Boston Scientific Announces FDA Clearance and CE Mark Approval for Advanix™ Biliary Stents. AccessGUDID - Advanix™ Biliary (08714729786764)- Biliary Stent. Uncovered WallFlex Biliary RX Stent System Boston Scientific Corporation Marlborough, MA. Ships Today! �` �X�
The covered WallFlex™ Biliary RX Stent should not migrate in this Magnetic Resonance Imaging (MRI) ... ©2017 Boston Scientific Corporation or its affiliates. Biliary Stent Sets. 0000006007 00000 n
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