GMDN Names and Definitions: Copyright GMDN Agency 2015. Endoscopically-placed stents are a clinically effective treatment for biliary Applicant. 0000002525 00000 n xref K203162. information and discussion. With endoscopic and radiopaque markers 1 for enhanced visualization 2, the Advanix Pancreatic Stent helps facilitate stent placement during procedure and at follow-up fluoroscopic examination. 0000002457 00000 n The Advanix biliary stent employs NaviFlex RX delivery system, which offers physicians the flexibility to employ both long-wire and short-wire guidewires during access and stent placement; The Advanix Boston Scientific has received Radiopaque marker on leading end of the Advanix Pancreatic Stent provides visibility under fluoroscopy.*. All trademarks are the property of their respective owners. 0000020391 00000 n Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. al., "Plastic biliary stent occlusion: factors involved and possible preventative approaches." Clinical Medicine and Research, 2007; 5(1); 53-60. GO&E*=~+QtU7[X;!,[%aAq/wd*=' (((1^III8-gRAP-@U , ! `n` , LKtp2aA}.8v3ln`T`WQb03`X`{a Ct ,O-PJ`t2x>00010800! This product line is serviced by the following clinical division (s): Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve. Endoscopic Placement 0000194722 00000 n 0000005940 00000 n 0000194654 00000 n 2023 Boston Scientific Corporation or its affiliates. Item Past Expiration. 0000194891 00000 n 0000005619 00000 n See all healthcare professional information, Lab Agent - restock products for your practice, Bladder leakage and pelvic organ prolapse, Enteral feeding tube and esophageal stent device support, Cardiac Resynchronization Therapy (CRT) device support, Peripheral Artery and Vein interventions device support, Transcatheter Aortic Valve Replacement device support, Spinal Cord Stimulator (SCS) systems device support, View Ordering Information for Straight Stent No Leading Barb, View Ordering Information for Straight Stent Leading Barb, View Ordering Information for Pigtail Stent No Leading Barb, View Ordering Information for Pigtail Stent Leading Barb, View Ordering Information for Pushers & Delivery System, Biliary Coding & Payment Quick Reference Guide, Indications, Safety, and Warnings - Delivery System, Indications, Safety, and Warnings - Pushers, EDUCARE Medical Education and Training Courses, ADVANTICS Innovative Healthcare Solutions, Do not sell or share my personal information, Leading radiopaque marker with trailing endo marker, NaviFlex RX Pancreatic Stent Delivery System. A magnetic field may interfere with the accuracy of an MRI, so patients should not be allowed to wear metal, hard plastic, or metal-containing items or wear metal-containing medical garments. Reference Part Numbers are not the same in all countries/regions. 510 (k) Number. Warnings: The safety and effectiveness of the stent has not been established for indwell periods exceeding 12 months. 138 0 obj<>stream Must read: What this policy does not cover / notable exceptions, This policy does not cover the use of MRI on patients with biliary stents that have been inserted outwith GRI, RAH and QEUH departments. Find products, medical specialty information, and education opportunities. 0000031716 00000 n Removability All images taken by Boston Scientific. Biliary stents (implanted at GRI, QEUH and RAH), Patient information sheet for MRI scanning during pregnancy. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. All rights reserved. `abi` 2"Hb? Request Customer Support Explore Product Details Ordering Information Reimbursement Physician & Patient Resources Product Details Disposable devices intended to assist implantation may be included. This policy covers Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. The patient should not be exposed to a magnetic field. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. Stents are not a magnetic resonance imaging (MRI) contrast medium. Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . We have had confirmation from the surgical team that within the following sites: GRI, RAH and QEUH MR Conditional biliary stents are used. All product related information made available on this website are for the reference of licensed healthcare professionals only. 0000022971 00000 n The WallFlex Biliary RX Fully Covered Stent should not be placed in strictures that cannot be dilated enough to pass the delivery system, in a perforated duct, or in very small intrahepatic ducts. A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed pancreatic duct (e.g., due to stricture or malignancy) to maintain luminal patency; it may also be intended to treat a wide variety of conditions in pancreatic endoscopy (e.g., drain pseudocyst, treat fistula or duct disruption). 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 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. In patients with a biliary stent inserted at GRI, RAH or QEUH sites can immediately following stent implantation, 1.5T or 3T MRI can safely proceed using the Normal Operating Mode of the scanner. Information for the use only in countries with applicable health authority product registrations. 1. 0000032476 00000 n United States Latin America Europe, Middle East & Africa Asia-Pacific What does EDUCARE offer? A biliary metal stent (also known as a "bile duct stent") is a flexible metallic tube specially designed to hold your bile duct open, which has been blocked or partially blocked. Risk assessment: A It was reported that an advanix biliary stent was implanted in the patient on an unknown date. Flexima Duodenal Bend Biliary Stent with Delivery System 23 Advanix Pancreatic Stent Kit - Pigtail, Leading Barb and . All device bench test results were acceptable. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. These stents may be used with short or long guidewires. The NaviFlex RN Delivery System will be offered in 202.5cm working length. 0000006584 00000 n Making a meaningful difference in patients' lives. 1Through non-clinical testing, the WallFlex Biliary RX Stent has been shown to be MR Conditional (poses no known hazards under specified conditions) when used according to conditions described in the Directions for Use. 0000003412 00000 n Moss A.; Morris E.; MacMathuna P.; Palliative biliary stents for obstructing pancreatic carcinoma. The Advanix Biliary Stent with NaviFlex RX Delivery System should only be used by or under the supervision of physicians thoroughly trained in endoscopic biliary procedures. 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. Above (WallFlex Biliary RX Fully Covered Stent System) with Permalumecovering. Brand Name: Advanix Biliary Version or Model: M00534320 Commercial Distribution Status: In Commercial Distribution Catalog Number: Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729787419 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 021717889 * Terms of Use Drainage holes are positioned every 5mm at 90 degree intervals to support drainage and patency. To aid in placement, the stent is constructed of a flexible yet durable polymer. 2023 Boston Scientific Corporation or its affiliates. The Advanix biliary stents are constmucted of a Polyethylene material. 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). Question - Answer 0. and QEUH departments. All rights reserved. Find products, medical specialty information, and education opportunities. All rights reserved. Stent lengths Standardplasticstent modelsareavailable inlengths rangingbe- Refer to package insert provided with the product for complete Indications for Use, Contraindications, Warnings, Precautions, and Adverse Events prior to using this product. Biliary stents MRI safety. trailer Boston Scientific Corporation. When a blockage occurs in the bile duct, fluids like bile (bilirubin) are unable to flow into the duodenum to aid in digestion. Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729787464 Issuing Agency: GS1 Commercial Distribution End Date: NA Device Count: 1 Device Description: Biliary Stent with NaviflexTM RX Delivery System Advanix Biliary - Device Characteristics Advanix Biliary - GMDN Advanix Biliary - Sterilization Safety Topic / Subject WallStent carotid artery stent Boston Scientific Corporation Maple Grove, MN . Stents provided pursuant to the Program will be accompanied by a no-charge invoice shipped directly to the hospital upon receipt of the appropriate documentation. 0000194996 00000 n Are you a Medical Device Company? BOSTON SCIENTIFIC BOSTON SCIENTIFIC Lead Pacemaker ICD S-ICD SEARCH / FILTERING ACCOLADE (L310, L311, L331) Field strength 1,5T full body 3T full body Exclusion zone No exclusion zone Specific conditions In combinaison with Boston Scientific compatible MRI leads Last update Tuesday, 25 October 2022 ACUITY SPIRAL (4591, 4592, 4593) Field strength 4. Boston Scientific will provide a replacement WallFlex Stent of identical dimensions if a covered or partially covered WallFlex Stent is implanted in accordance with the terms of the Program and the physician is not satisfied with the patency of the stent during the first year, and all other terms of the Program are fulfilled. FDA.report GUDID BOSTON SCIENTIFIC CORPORATION 08714729786825. nal diameters of plastic biliary stents are 7.0, 8.5, 10.0, and 11.5Fr; it would be difficult or impossible to introduce larger stents through most standard therapeutic duodenoscopes with working channels that measure 4.2mm in diameter. 2023 Boston Scientific Corporation or its affiliates. The Advanix Biliary Stent preloaded with NaviFlex RX Delivery System is designed to maximize flow rates, improve pushability through tortuous anatomy, and be repositionable to aid in accurate placement. Tissue In-Growth Prevention 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. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. Advisa DR MRI SureScan Pacing System (Advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads) More. Soderlund K., Linder S.; Covered metal versus plastic stents for malignant common bile duct stenosis: a prospective, randomized, controlled trial. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. MRI Information for Healthcare Professionals - Boston Scientific Customer support MRI Information MRI Information 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. The delivery system consists of a guide catheter and outer push catheter. 0000010863 00000 n *Fluoroscopic image from animal lab testing. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 0000001096 00000 n EDUCARE - Boston Scientific Online medical training & education courses EDUCARE is a comprehensive suite of education and training programs that support healthcare professionals in the delivery of patient care worldwide. Coils, Filters, Stents, and Grafts More. 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'' guidewires, including Dreamwire Guidewire including Dreamwire Guidewire following clinical division s.: No warranty is made with regard to Removability of this Device by endoscopic means or otherwise: the and.: Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve Uncovered biliary Stent with Delivery System consists of a flexible durable.