Weight: 5.00 oz. 2023 Boston Scientific Corporation or its affiliates. Catalog Number: Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729856214 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 021717889 * Terms of Use Device Description: RX Pusher CLOSE Device Characteristics Device Record Status Alternative and Additional Identifiers Customer Contact 0000022971 00000 n Advanix BiliaryStent with NaviFlex RX Delivery System Why place a stent? GO&E*=~+QtU7[X;!,[%aAq/wd*=' (((1^III8-gRAP-@U , ! `n` , LKtp2aA}.8v3ln`T`WQb03`X`{a Ct ,O-PJ`t2x>00010800! 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). **** Endoscopic and fluoroscopic images courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD. The patient should not be exposed to a magnetic field. Stents are not a magnetic resonance imaging (MRI) contrast medium. 2023 Boston Scientific Corporation or its affiliates. risk assessment underpinning this policy can be found here: This policy does not cover the use of MRI on patients with biliary stents that have been inserted outwith GRI, RAH and QEUH department, Additional background Consumers or patients who use this website and rely on any information herein do so at their own risk. Advanix Pancreatic Stent and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers Available in a variety of French sizes and lengths. 1.5: Safe More. 0000003412 00000 n 0 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). 3: Conditional 6 More. ** In the event of incorrect positioning during the initial stent placement procedure, the partially covered and fully covered stent options may be removed using forceps to grasp the retrieval loop on the end of the stent. DISCLAIMERS: Please note that access to certain information on the following pages is intended for healthcare professionals. Global Unique Device ID: 08714729787402. 0000002593 00000 n All rights reserved. Disposable devices intended to assist implantation may be included. All rights reserved. `abi` 2"Hb? The delivery system The data demonstrate that the Advanix Double Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939 . Looped and flared stent ends are designed to help reduce the risk of tissue trauma and stent migration. 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. 0000027207 00000 n 0000003127 00000 n Please note that the following pages are exclusively reserved for health care professionals in countries with applicable health authority product registrations. PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS. Intended Use/Indications for Use: The WallFlex Biliary RX Stents are indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2, Flexibility Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Request Customer Support Explore Product Details Ordering Information Reimbursement Physician & Patient Resources Product Details Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Stent Placement Accuracy %%EOF Post date June 29, 2022; Categories In words to describe your personal identity; name a creature that invades your home family feud . Introducer components sold separately. HW[%~_fLF^&II6ZjKNw~?k_<=5ZoKrdO&]L,o/$_otBM=n]oDbe. 0000006770 00000 n Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. 138 0 obj<>stream All trademarks are property of their respective owners. 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 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, EDUCARE Medical Education and Training Courses, ADVANTICS Innovative Healthcare Solutions, Do not sell or share my personal information. LIMITATIONS The NaviFlex RN Delivery System will be offered in 202.5cm working length. 4. Device Name. The fully covered stent is indicated for indwell up to 12 months after placement in benign biliary strictures secondary to chronic pancreatitis. 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. CAUTION: The law restricts these devices to sale by or on the order of a physician. Replacement stents provided under the Program are not eligible for the Program. United States Latin America Europe, Middle East & Africa Asia-Pacific What does EDUCARE offer? Maximized Lumenal Integrity Thin wall design for maximized inner diameter - full length of stent designed to maximize flow rates and help reduce clogging Improved Deliverability Tapered stent tip design to . The NaviFlex RN Delivery System will be offered in 202.5cm working length. 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. endstream endobj 100 0 obj<> endobj 101 0 obj<>/Shading<>/ColorSpace<>/Font<>/ProcSet[/PDF/Text/ImageC]/ExtGState<>>>/Type/Page>> endobj 102 0 obj<> endobj 103 0 obj[/Separation/PANTONE#203145#20C/DeviceCMYK 131 0 R] endobj 104 0 obj[/Separation/PANTONE#203145#20C/DeviceCMYK 129 0 R] endobj 105 0 obj<> endobj 106 0 obj<> endobj 107 0 obj<> endobj 108 0 obj<> endobj 109 0 obj<> endobj 110 0 obj<> endobj 111 0 obj<>stream Radial force helps maintain stent patency and resist migration. Find out who we are, explore careers at the company, and view our financial performance. trailer Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 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. %PDF-1.4 % Contraindications: and QEUH departments. CAUTION: The law restricts these devices to sale by or on the order of a physician. Contraindications: Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. Biliary strictures can be categorized as benign biliary stricture (BBS) or malignant biliary stricture (MBS). Introduction Stenting of the pancreas is a challenging task for the interventional gastroenterologist. 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. Description. 0000194891 00000 n GMDN Names and Definitions: Copyright GMDN Agency 2015. According to the MHRA (2014 section 4.11.2.4) each biliary stent needs to be identified to determine its MRI safety status, usually by reference to the manufacturers literature. Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. This product line is serviced by the following clinical division (s): Endoscopy The products on this website are available for sale in the United States. The WallFlex Biliary RX Fully Covered Stent System RMV is for single-use only. This policy covers The hospital is responsible for reporting the replacement stent as a discount on the hospitals cost report. 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 Advanix Duodenal Bend Preloaded RX Stent Systems Disposable devices intended to assist implantation may be included. al., "Plastic biliary stent occlusion: factors involved and possible preventative approaches." Clinical Medicine and Research, 2007; 5(1); 53-60. 2023 Boston Scientific Corporation or its affiliates. Cochrane Database Systematic Review, 25 Jan. 2006. Data claim does not apply to the 3Fr stent. 2023 Boston Scientific Corporation or its affiliates. All rights reserved. 0000002457 00000 n Disposable devices intended to assist implantation may be included. First; Previous; . Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . 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. K203162. Biliary stents (implanted at GRI, QEUH and RAH), Patient information sheet for MRI scanning during pregnancy. Biliary stents MRI safety. ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. Neuroform Atlas Stent Non-clinical testing and analysis have demonstrated that the Neuroform Atlas Stent is MR Conditional alone, or when overlapped with a second stent, and adjacent to a Stryker Neur During two routine follow ups in the clinic after plastic stent placement, it was reported that the patient came in with pain in the middle of the night and showed that the stent had migrated into the sigmoid colon and had a perforation. Shape Diameter (Fr) Length (cm) Package Quantity Request Pricing Product Documentation Instructions for Use Contact your Territory Manager to learn more. 0000002030 00000 n CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. Boston Scientific Advanix biliary stents win FDA, CE mark . These stents may be used with short or long guidewires. Find products, medical specialty information, and education opportunities. Find out who we are, explore careers at the company, and view our financial performance. The Stent has Radio-opaque markers at both ends and center of the Stent EGIS@ Biliary Stent has designed a self-expandable property made of Nitinol Wire which means Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. stents, drains and dilators for the biliary ducts: 510(k) Number: K101314: Device Name: ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM: Applicant: BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY . Aequalis Humeral Plate and component parts FDA.report GUDID BOSTON SCIENTIFIC CORPORATION 08714729786825. Available in a variety of French sizes and lengths. All consumers or patients are advised to consult their doctor or physician for advice on medical devices or any health related matters. 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. 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. 0000194722 00000 n 0000000016 00000 n 0000018586 00000 n Version (Model) Number: M00534310. - Boston Scientific Medical device safety alert: boston scientific advanix biliary stent with naviflex rx delivery system medical device manufacturer, boston scientific corporation issued a medical device safety alert concerning advanix biliary stent with naviflex rx delivery system (catalogue number: 3427 . 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. Reproduced with Permission from the GMDN Agency. We have had confirmation from the surgical team that within the following sites: GRI, RAH and QEUH MR Conditional biliary stents are used. All rights reserved. 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. The safety and effectiveness of the WallFlex Biliary RX Fully Covered Stent System RMV has not been established in the treatment of benign biliary anastomotic strictures in liver transplant patients and benign biliary post abdominal surgery strictures. 0000006359 00000 n 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. 0000031716 00000 n 1. All images taken by Boston Scientific. *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. 0000194654 00000 n 0000005940 00000 n 0000003219 00000 n 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. Soderlund K., Linder S.; Covered metal versus plastic stents for malignant common bile duct stenosis: a prospective, randomized, controlled trial. Please refer to your Boston Scientific representative to check product registration and/or availability in your country. Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose . Find products, medical specialty information, and education opportunities. 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. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 0000194996 00000 n To aid in placement, the stent is constructed of a flexible yet durable polymer. To the extent this site contains information, reference guides and databases intended for use by licensed medical professionals, such materials are not intended to offer professional medical advice. Wallstent platinum and cobalt-alloy coil, stent, filter Schneider Bulach, Switzerland. Endoscopically-placed stents are a clinically effective treatment for biliary and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers. All device bench test results were acceptable. Migration Resistance Miscellaneous Implants . 2022 Boston Scientific Corporation. CAUTION: Federal Law (USA) restricts these devices to sale by or on the order of a physician. This represents the first metal biliary stent in the United States which has been cleared for use in the treatment of benign biliary strictures secondary to chronic pancreatitis. This product line is serviced by the following clinical division (s): Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve. A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. 100 Boston Scientific Way. Applicant Contact. 0000012830 00000 n Radiopaque marker on leading end of the Advanix Pancreatic Stent provides visibility under fluoroscopy.*. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. Above (WallFlex Biliary RX Fully Covered Stent System) with Permalume covering. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Please check availability with your local sales representative or customer service. Tissue In-Growth Prevention Boston Scientific Corporation. 2014 Copyright Boston Scientific Corporation. Find out who we are, explore careers at the company, and view our financial performance. The delivery system consists of a guide catheter and outer push catheter. the use of 1.5T and 3T MRI on patients with biliary stents inserted at GRI, RAH EGIS@ Biliary Stent consists of 4 type of style named Single Bare,Single Covered, Double Bare, Double Covered and Catheter which guides the Stent to the disease region. startxref Safety Topic / Subject WallStent carotid artery stent Boston Scientific Corporation Maple Grove, MN . Item Past Expiration. Refer to package insert provided with the product for complete Indications for Use, Contraindications, Warnings, Precautions, and Adverse Events prior to using this product. Coils, Filters, Stents, and Grafts More. Flexima Duodenal Bend Biliary Stent with Delivery System 23 Advanix Pancreatic Stent Kit - Pigtail, Leading Barb and . Advanix Biliary Stent with NaviFlex RX Delivery System. 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. Brand Name: Advanix Biliary. Risk assessment: A Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. 0000016595 00000 n Coils, Filters, Stents, and Grafts More. 0000005372 00000 n The WallFlex Biliary RX Fully Covered Stent System RMV is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms, relief of malignant biliary obstruction prior to surgery and for indwell up to 12 months in the treatment of benign biliary strictures secondary to chronic pancreatitis. In previous cases, MBS occurred in 72% of patients with biliary stricture. Applicant Contact: ELENA NIEVES: Correspondent: BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY: MARLBOROUGH, MA 01752 Correspondent . Pharmaceutical-business-review.com DA: 34 PA: 50 MOZ Rank: 24. Are you a Medical Device Company? This offer applies only to covered and partially covered WallFlex Stents endoscopically placed in accordance with the Direction For Use after May 1, 2014. 0000032476 00000 n For health care professionals in EUROPE excepted those practicing in France as the following pages are intended to all International health care professionals and are not in compliance with the French Advertising law N2011-2012 dated 29th December 2011 article 34. All rights reserved. DISCLAIMERS: INDICATIONS FOR USE in the United States: Device Name: Biliary Stent with NaviflexTM RX Delivery System. Maple Grove, M. 3: Safe More. Applicant. 043254. About Boston Scientific. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. A thorough understanding of the technical principles, clinical applications, and risks associated with endoscopic biliary stent procedures is necessary before using this . Advanix and NaviFlex are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. Find out who we are, explore careers at the company, and view our financial performance. ** In the event of incorrect positioning during the initial stent placement procedure, the partially covered and fully covered stent options may be removed using forceps to grasp the retrieval loop on the end of the stent. This is the definitive textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists, scientists, MRI facility . 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. May be removed prior to MRI and replaced after the MRI exam. Coils, Filters, Stents, and Grafts More . The safety and effectiveness of the WallFlex Biliary RX Fully Covered Stent System RMV for use in the vascular system has not been established. Platinol Wire construction provides flexibility to help aid placement in tortuous anatomies.*. Packaging is color coded by French size, allowing nurses and technicians to quickly identify the desired size. Drainage holes are positioned every 5mm at 90 degree intervals to support drainage and patency. Safety Topics; Home; help (full/part words) This site is Exclusively Sponsored by BRACCO . Wallflex Biliary RX Stents Prescriptive Information Refer to the device directions for use for complete instructions on device use. 0000002795 00000 n The Advanix Biliary Stent will be will be offered in 7Fr, 8.5Fr, and lOFr diameters. Removability 3: Safe More. The sale, distribution, and use of the device are restricted to prescription use in 2023 Boston Scientific Corporation or its affiliates. Advisa DR MRI SureScan Pacing System (Advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads) More. However we can not guarantee for any material, property or completeness. Information given here is checked thoroughly by "Implant-Register". The Program is subject to modification or termination by Boston Scientific without prior notification. Find products, medical specialty information, and education opportunities. xref Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. 99 40 0000006218 00000 n The Advanix biliary stents are constmucted of a Polyethylene material. 0000005619 00000 n 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 Biliary Stent BOSTON SCIENTIFIC CORPORATION. 0000194782 00000 n All product related information made available on this website are for the reference of licensed healthcare professionals only. Explore online and in-person resources to advance your skills and manage your practice with physician-led videos, specialized training, and reimbursement tools. 0000001096 00000 n Brand Name: Advanix Biliary Version or Model: M00534330 Commercial Distribution Status: In Commercial Distribution Catalog Number: Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729787426 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 021717889 * Terms of Use The indications for pancreatic stent implantation are either prophylactic or Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, . 0000006007 00000 n This material not intended for use in France. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting, 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, Advanix Biliary Stent with NaviFlex RX Delivery System, View Ordering Information for Advanix Duodenal Bend Preloaded RX Stent Systems, View Ordering Information for Advanix Center Bend Preloaded RX Stent Systems, View Ordering Information for Advanix Duodenal Bend - Single Stent, View Ordering Information for Advanix Center Bend - Single Stent, View Ordering Information for Advanix Double Pigtail - Single Stent, View Ordering Information for NaviFlex Rx Delivery System*, Stenting Coding & Payment Quick Reference Guide, EDUCARE Medical Education and Training Courses, ADVANTICS Innovative Healthcare Solutions, Do not sell or share my personal information. In the United States, the WallFlex Biliary RX Stent is cleared for use in the palliative treatment of biliary strictures produced by malignant neoplasms and relief of malignant biliary obstruction prior to surgery. All trademarks are the property of their respective owners. The Advanix Biliary Stent and NaviFlex RX Delivery System are available in a variety of options: RX pre-loaded systems, singles, multiple sizes and shapes to accommodate physician preferences, different disease states and patient anatomies. Endo-232507-AA April 2014, Advanix Biliary Stent with NaviFlex RX Delivery System, View Ordering Information for Advanix Duodenal Bend Preloaded RX Stent Systems, View Ordering Information for Advanix Center Bend Preloaded RX Stent Systems, View Ordering Information for Advanix Duodenal Bend - Single Stent, View Ordering Information for Advanix Center Bend - Single Stent, View Ordering Information for Advanix Double Pigtail - Single Stent, View Ordering Information for NaviFlex Rx Delivery System*. All rights reserved. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. The RX biliary delivery system is reconstrainable up to 80% of deployment to aid in repositioning*** and is designed to facilitate physician control. Reconstrainable delivery system (up to 80%) facilitates physician control and locking of guidewire, Looped and flared stent ends designed to reduce the risk of tissue trauma and stent migration, Platinol Wire construction provides flexibility to aid placement in tortuous anatomies. * Compatible with Boston Scientific .035" guidewires, including Dreamwire. Fully covered stent is designed for removal up to 12 months post-placement. Stent lengths Standardplasticstent modelsareavailable inlengths rangingbe- In no case shall Boston Scientific India Private Limited, or any of its affiliates, directors or employees be liable to any person or entity for any damages or losses resulting either directly or indirectly from the access of information provided in this website. Refer to the . accordance with 21 CFR 801.109 * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. 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). Therefore, the Advanix Double Pigtail Biliary Stent is considered biocompatible for its intended use. Find products, medical specialty information, and education opportunities. 4. 0000003307 00000 n *** A stent cannot be reconstrained after the reconstrainment line has been exceeded
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