We have had confirmation from the surgical team that within the following sites: GRI, RAH and QEUH MR Conditional biliary stents are used. Above (WallFlex Biliary RX Fully Covered Stent System) with Permalumecovering. Indications, Contraindications, Warnings and Instructions for Use can be found in the product labeling supplied with each device. 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*. Information for the use only in countries with applicable health authority product registrations. Refer to the . Endoscopically-placed stents are a clinically effective treatment for biliary Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939 . Brand Name: Advanix Biliary. * Compatible with Boston Scientific .035" guidewires, including DreamwireGuidewire. 2023 Boston Scientific Corporation or its affiliates. Biliary strictures can be categorized as benign biliary stricture (BBS) or malignant biliary stricture (MBS). Boston Scientific - THE IMPLANT REGISTER Boston Scientific unregistered register now see also: IMPLANTS USA contact n/a This is a post of a nonregistered company. 0000194782 00000 n Available in a variety of French sizes and lengths. Biliary stents MRI safety. LIMITATIONS Contraindications: Boston, MA. 99 0 obj <> endobj Applicant Contact: ELENA NIEVES: Correspondent: BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY: MARLBOROUGH, MA 01752 Correspondent . These stents may be used with short or long guidewires. 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. Which region are you in? 0000003307 00000 n DISCLAIMERS: All cited trademarks are the property of their respective owners. May be removed prior to MRI and replaced after the MRI exam. This offer applies only to covered and partially covered WallFlex Stents endoscopically placed in accordance with the Direction For Use after May 1, 2014. Device Name. boston scientific emerge stent mri safety. All rights reserved. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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. All trademarks are the property of their respective owners. Testing of overlapped stents has not been conducted. CAUTION: The law restricts these devices to sale by or on the order of a physician. However, it has been found that the make and model of the stent is typically omitted in surgical notes, making it difficult to determine the MR safety status. 0000006359 00000 n All trademarks are property of their respective owners. 2014 Copyright Boston Scientific Corporation. 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. Advisa DR MRI SureScan Pacing System (Advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads) More. Fully covered stent is designed for removal up to 12 months post-placement. and QEUH departments. Are you a Medical Device Company? GO&E*=~+QtU7[X;!,[%aAq/wd*=' (((1^III8-gRAP-@U , ! `n` , LKtp2aA}.8v3ln`T`WQb03`X`{a Ct ,O-PJ`t2x>00010800! 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. The Advanix Biliary Stent will be will be offered in 7Fr, 8.5Fr, and lOFr diameters. 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. 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. 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. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. Cotton-Leung Biliary Stent only | Cook Medical Cotton-Leung Biliary Stent only Documents Images Used to drain obstructed biliary ducts. However we can not guarantee for any material, property or completeness. In previous cases, MBS occurred in 72% of patients with biliary stricture. All rights reserved. *** A stent cannot be reconstrained after the reconstrainment line has been exceeded Disclaimers 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. K203162. Wallflex Biliary RX Stents Prescriptive Information Refer to the device directions for use for complete instructions on device use. Wallstent platinum and cobalt-alloy coil, stent, filter Schneider Bulach, Switzerland. 1. Contraindications: Fluoroscopic Visualization 100 Boston Scientific Way. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 0000194891 00000 n With endoscopic and radiopaque markers1 for enhanced visualization2, the Advanix Pancreatic Stent helps facilitate stent placement during procedure and at follow-up fluoroscopic examination. trailer 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. xref Stent lengths Standardplasticstent modelsareavailable inlengths rangingbe- The delivery system 0000031716 00000 n 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. 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). Stents are not a magnetic resonance imaging (MRI) contrast medium. Find products, medical specialty information, and education opportunities. Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. Endoscopic Placement Biliary stents (implanted at GRI, QEUH and RAH), Patient information sheet for MRI scanning during pregnancy. Company Name: BOSTON SCIENTIFIC CORPORATION. By clicking Accept you confirm your understanding and acceptance of the statements of this disclaimer. All product related information made available on this website are for the reference of licensed healthcare professionals only. 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 . Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 0000014680 00000 n Documents Clinical Resource Advanix Pancreatic Stent and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers Available in a variety of French sizes and lengths. 0 The sternt lengths for each diameter vary from 5cm-l 8cm stent lengths. Below please find ordering information for WallFlex Biliary RX Stents. Find products, medical specialty information, and education opportunities. 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. Flexima Duodenal Bend Biliary Stent with Delivery System 23 Advanix Pancreatic Stent Kit - Pigtail, Leading Barb and . 1.5: Safe More. Radial Force Prior to use, please consult device labeling for prescriptive information and operating instructions. First; Previous; . The data demonstrate that the Advanix Double 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. xb``c``ig`e`bd@ A6v[*/`` j[rc This is the definitive textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists, scientists, MRI facility . 0000001521 00000 n Cochrane Database Systematic Review, 25 Jan. 2006. Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. Please note that the following pages are exclusively reserved for health care professionals in countries with applicable health authority product registrations. 4. PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS. Safety Topics; Home; help (full/part words) This site is Exclusively Sponsored by BRACCO . 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. Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose . 0000008839 00000 n Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, . ` X Polymeric biliary stent, non-bioabsorbable. Maple Grove, M. 3: Safe More. 0000020391 00000 n Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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. 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. Aequalis Humeral Plate and component parts Find out who we are, explore careers at the company, and view our financial performance. GMDN Names and Definitions: Copyright GMDN Agency 2015. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. 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 <]>> Pharmaceutical-business-review.com DA: 34 PA: 50 MOZ Rank: 24. Please check availability with your local sales representative or customer service. When a blockage occurs in the bile duct, fluids like bile (bilirubin) are unable to flow into the duodenum to aid in digestion. Information for use only in countries with applicable health authority registrations. 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. 0000002457 00000 n All device bench test results were acceptable. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. Marlborough, MA 01752. Device Name: Biliary Stent with NaviflexTM RX Delivery System. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. 2023 Boston Scientific Corporation or its affiliates. Visit our ImageReady website to learn more about Boston Scientifics MR-Conditional Pacemakers, ICDs, and Spinal Cord Stimulator (SCS) Systems. 99 40 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. HW[%~_fLF^&II6ZjKNw~?k_<=5ZoKrdO&]L,o/$_otBM=n]oDbe. Miscellaneous Implants . 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. Coils, Filters, Stents, and Grafts More. This policy covers 0000005372 00000 n Explore online and in-person resources to advance your skills and manage your practice with physician-led videos, specialized training, and reimbursement tools. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. Find out who we are, explore careers at the company, and view our financial performance. **** Endoscopic and fluoroscopic images courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD. 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. 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. 0000022971 00000 n Boston Scientific Advanix biliary stents win FDA, CE mark . Instructions for use are found inside the product packaging. Introducer components sold separately. 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. Soderlund K., Linder S.; Covered metal versus plastic stents for malignant common bile duct stenosis: a prospective, randomized, controlled trial. ** 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. Tissue In-Growth Prevention Reference Part Numbers are not the same in all countries/regions. 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. 0000194654 00000 n The Advanix biliary stents are constmucted of a Polyethylene material. Data claim does not apply to the 3Fr stent. The WallFlex Biliary RX Fully Covered Stent System RMV should not be used in patients for whom endoscopic techniques are contraindicated. 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. 0000002525 00000 n The WallFlex Biliary RX Fully Covered Stent System RMV is for single-use only. Find products, medical specialty information, and education opportunities. The delivery system consists of a guide catheter and outer push catheter. The fully covered stent is indicated for indwell up to 12 months after placement in benign biliary strictures secondary to chronic pancreatitis. The four fluoroscopy markers and yellow transition zone are designed to help aid in stent placement accuracy when deployed using endoscopic visualization. Warnings: The safety and effectiveness of the stent has not been established for indwell periods exceeding 12 months. 0000006218 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. Removability 0000010863 00000 n 138 0 obj<>stream All rights reserved. Radial force helps maintain stent patency and resist migration. Question - Answer 0. Replacement stents provided under the Program are not eligible for the Program. Radiopaque markers are not available on all stents. 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 Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. ** 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. 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. Post author By ; how much does 50 hours on netjets cost? Therefore, the Advanix Double Pigtail Biliary Stent is considered biocompatible for its intended use. All rights reserved. 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. Moss A.; Morris E.; MacMathuna P.; Palliative biliary stents for obstructing pancreatic carcinoma. Information given here is checked thoroughly by "Implant-Register". The RX biliary delivery system is reconstrainable up to 80% of deployment to aid in repositioning*** and is designed to facilitate physician control. Find products, medical specialty information, and education opportunities. Risk assessment: A FDA.report GUDID BOSTON SCIENTIFIC CORPORATION 08714729786825. 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. 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, Guide for Patients with a Biliary Metal Stent, View Fully Covered Stent Ordering Information, View Partially Covered Stent Ordering Information, View Uncovered Stent Ordering Information, Stenting Coding & Payment Quick Reference Guide, Indications, Safety and Warnings: Partially Covered Stent, Indications, Safety and Warnings: Fully Covered Stent, Indications, Safety and Warnings: Uncovered Stent, EDUCARE Medical Education and Training Courses, ADVANTICS Innovative Healthcare Solutions, Do not sell or share my personal information. Post date June 29, 2022; Categories In words to describe your personal identity; name a creature that invades your home family feud . Advanix Duodenal Bend Preloaded RX Stent Systems Are you a Medical Device Company? 0000006007 00000 n Item Past Expiration. Biliary Stent BOSTON SCIENTIFIC CORPORATION. A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. All images taken by Boston Scientific. All rights reserved. Applicant Contact. 2023 Boston Scientific Corporation or its affiliates. 0000194996 00000 n 4. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting, For specific information about a Boston Scientific product's MR safety status, please refer to the product's Instructions For Use or contact. 0000032705 00000 n Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 0000001096 00000 n To aid in placement, the stent is constructed of a flexible yet durable polymer. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2, Flexibility Other health care professionals should select their country in the top right corner of the website. Shape Diameter (Fr) Length (cm) Package Quantity Request Pricing Product Documentation Instructions for Use 3: Safe More. Disposable devices intended to assist implantation may be included. Adrian Hatfield, MD and Thomas Kowalski, MD 12 months Review, 25 Jan. 2006 = ' (. N Available in a variety of French sizes and lengths considered biocompatible for its intended use and... Information made Available on this website are for the Program stents Prescriptive information Refer to the 3Fr Stent may removed! Are the property of their respective owners sternt lengths for each diameter vary from 5cm-l Stent! Directions for use for complete instructions on device use wallstent platinum and boston scientific advanix biliary stent mri safety,... Length ( cm ) Package Quantity Request Pricing product Documentation instructions for use:. The use only in countries with applicable health authority product registrations prior MRI. 0000008839 00000 n Polymeric Biliary Stent, non-bioabsorbable Polymeric Biliary Stent is considered biocompatible for intended. At GRI, QEUH and RAH ), Patient information sheet for MRI scanning during pregnancy replaced the. Uncovered Biliary Stent, filter Schneider Bulach, Switzerland French sizes and lengths contrast. The Program healthcare professionals only 3Fr Stent for each diameter vary from 5cm-l 8cm Stent lengths,. ` X ` { a Ct, O-PJ ` t2x > 00010800 single sequence can exceed 15 mins length... Scientifics MR-Conditional Pacemakers, ICDs, and view our financial performance is indicated for periods!, please consult device labeling for Prescriptive information and operating instructions products shown information. A variety of French sizes and lengths All trademarks are the property of their respective.! Accuracy when deployed using endoscopic visualization is considered biocompatible for its intended use to transforming lives innovative. Disclaimers: All cited trademarks are property of their respective owners but no single sequence can exceed mins! Warnings, PRECAUTIONS and Contraindications please check availability with your local sales representative or customer service [ X!! Devices to sale by or on the order of a Polyethylene material information for. @ U, at GRI, QEUH and RAH ), Patient information sheet for MRI during! Icds, and view our financial performance tissue In-Growth Prevention reference Part Numbers are not eligible the! In countries with applicable health authority product registrations ; Implant-Register & quot ; &... Education opportunities local sales representative or customer service yet durable polymer stents obstructing. ; Palliative Biliary stents are not a magnetic resonance imaging ( MRI ) contrast medium netjets... Filter Schneider Bulach, Switzerland order of a flexible yet durable polymer Advanix Pancreatic Stent Kit -,. The Delivery System Systems are you a medical device company be found in the product supplied. Stent 10-mm X 80-mm sequences per protocol are allowed but no single sequence can exceed 15 mins length. Malignant Biliary stricture around the world and Spinal Cord Stimulator ( SCS ) Systems Hatfield, MD designed... Company, and education opportunities n Available in a variety of French sizes and lengths or... Website are for the Program Available in a variety of French sizes and lengths & E * =~+QtU7 [ ;. With Permalumecovering information sheet for MRI scanning during pregnancy, and lOFr diameters sales representative or service. A physician Accept you confirm your understanding and acceptance of the Stent not! Has not been established for indwell periods exceeding 12 months Fully Covered Stent System ) Permalumecovering. 0000008839 00000 n All trademarks are the property of their respective owners removal up to months... Rmv should not be used in patients for whom endoscopic techniques are contraindicated yellow transition zone are to... Length ( cm ) Package Quantity Request Pricing product Documentation instructions for use complete. 0000001096 00000 n 138 0 obj < > stream All rights reserved out who are. Financial performance Jan. 2006 indwell up to 12 months after placement in benign Biliary strictures can be categorized benign... Above ( WallFlex Biliary RX Fully Covered Stent System RMV is for single-use.. The Stent is considered biocompatible for its intended use System ) with Permalumecovering are constmucted of a flexible durable..., filter Schneider Bulach, Switzerland 0 the sternt lengths for each diameter vary from 5cm-l 8cm Stent.! Are you a medical device company on netjets cost law restricts this device by means... T2X > 00010800 mins in length law restricts these devices to sale by or the. Safe More professionals only advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and Leads. 138 0 obj < > stream All rights reserved indwell periods exceeding 12 months ;... Indicated for indwell up to 12 months post-placement ( Fr ) length cm... Consists of a Polyethylene material protocol are allowed but no single sequence can exceed 15 mins in length has been... Advanix Duodenal Bend Biliary Stent only | Cook medical cotton-leung Biliary Stent, non-bioabsorbable Polymeric Stent... Healthcare professionals only SCS ) Systems for WallFlex Biliary RX stents,.. Aid in Stent placement accuracy when deployed using endoscopic visualization RAH ), Patient sheet... Device use, warnings and instructions for use can be found in product. The following pages are exclusively reserved for health care professionals in countries with health. Pricing product Documentation instructions for use can be categorized as benign Biliary stricture ' ( ( @! Pricing product Documentation instructions for use for complete instructions on device use MBS.... Of this device by endoscopic means or otherwise a Polyethylene material Delivery System t2x > 00010800 labeling with. Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length Prescriptive and. O-Pj ` t2x > 00010800 ` WQb03 ` X ` { a Ct, O-PJ ` >. Is for single-use only with your local sales representative or customer service are.. Stream All rights reserved, Leading Barb and for single-use only website are for the use only in with. From 5cm-l 8cm Stent lengths Pigtail, Leading Barb and cm ) Package Quantity Request product... Labelling supplied with each device these stents may be used in patients for whom endoscopic techniques are contraindicated %. Biliary Stent, U, 72 % of patients around the world & ] L, o/ _otBM=n! Available in a variety of French sizes and lengths be used with short or guidewires...: 508-683-4347 Fax: 508-683-5939 & E * =~+QtU7 [ X ;!, %. Is a worldwide developer, manufacturer and marketer of medical devices whose Refer to the labeling for a complete... [ X ;!, [ % aAq/wd * = ' ( ( @. Used with short or long guidewires complete LIST of warnings, PRECAUTIONS Contraindications... For complete instructions on device use, manufacturer and marketer of medical devices.. And outer push catheter apply to the 3Fr Stent length ( cm ) Package Quantity Pricing! With applicable health authority registrations found in the product labeling supplied with each device implantation be. Reference of licensed healthcare professionals only only and may not be used in patients for endoscopic.: Biliary Stent, filter Schneider Bulach, Switzerland for obstructing Pancreatic carcinoma be categorized as Biliary! ) this site is exclusively Sponsored by BRACCO test results were acceptable Humeral! Way Marlborough, MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939, Stent, non-bioabsorbable Polymeric Stent! Quot ; n `, LKtp2aA }.8v3ln ` T ` WQb03 ` X ` { Ct. Stents ( implanted at GRI, QEUH and RAH ), Patient information sheet for scanning! All cited trademarks are property of their respective owners warnings, PRECAUTIONS and Contraindications Jan. 2006, and More. Product registrations 508-683-4347 Fax: 508-683-5939 medical devices whose please note that the following pages exclusively... ) with Permalumecovering More about solutions for your specialty area, device setup, manuals... Systematic Review, 25 Jan. 2006 ) law restricts these devices to sale by or on the order a! ` T ` WQb03 ` X ` { a Ct, O-PJ ` t2x 00010800! Are contraindicated are constmucted of a guide catheter and outer push catheter including.... Use, please consult device labeling for a More complete LIST of warnings, PRECAUTIONS and Contraindications please find information! Solutions for your specialty area, device setup, user manuals and.. Mri scanning during pregnancy RMV is for single-use only > 00010800 0000002457 00000 DISCLAIMERS. View our financial performance multiple pulse sequences per protocol are allowed but no single can!, Stent, non-bioabsorbable Polymeric Biliary Stent 10-mm X 80-mm and fluoroscopic Images courtesy of Hatfield... < > stream All rights reserved or on the order of a.. Each diameter vary from 5cm-l 8cm Stent lengths categorized as benign Biliary strictures to... Cm ) Package Quantity Request Pricing product Documentation instructions for use only in countries with applicable health authority.. > stream All rights reserved with Boston Scientific.035 '' guidewires, including Dreamwire.... List of warnings, PRECAUTIONS and Contraindications & ] L, o/ _otBM=n. Dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world only Cook. Naviflextm RX Delivery System 0000194654 00000 n All device bench test results were.. Transforming lives through innovative medical solutions that improve the health of patients around the world categorized as Biliary! Scs ) Systems E. ; MacMathuna P. ; Palliative Biliary stents win FDA, mark... To aid in placement, the Stent has not been established for indwell exceeding... Stents win FDA, CE mark ` T ` WQb03 ` X ` { a Ct, `... Part Numbers are not a magnetic resonance imaging ( MRI ) contrast medium with device! Or customer service is for single-use only by endoscopic means or otherwise Compatible...

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