DISCLAIMERS: All cited trademarks are the property of their respective owners. Are you a Medical Device Company? Boston Scientific Corporation. MRI BIOEFFECTS, SAFETY, AND PATIENT MANAGEMENT: SECOND EDITION is a comprehensive, authoritative textbook on the health and safety concerns of MRI technology that contains contributions from more than fifty internationally respected experts in the field. Biliary stents (implanted at GRI, QEUH and RAH), Patient information sheet for MRI scanning during pregnancy. Looped and flared stent ends are designed to help reduce the risk of tissue trauma and stent migration. 2014 Copyright Boston Scientific Corporation. **** Endoscopic and fluoroscopic images courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD. Company Name: BOSTON SCIENTIFIC CORPORATION. Warnings: The safety and effectiveness of the stent has not been established for indwell periods exceeding 12 months. Disposable devices intended to assist implantation may be included. 100 Boston Scientific Way. and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers. BBS is generally caused by injury to the bile duct or benign biliary disease, while MBS is generally the result of malignant bile duct tumors. Contraindications: Visit our ImageReady website to learn more about Boston Scientifics MR-Conditional Pacemakers, ICDs, and Spinal Cord Stimulator (SCS) Systems. 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. Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. 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 MRI Information for Healthcare . Brand Name: Advanix Pancreatic Stent Commercial Distribution Status: In Commercial Distribution Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729857792 Issuing Agency: GS1 Commercial Distribution End Date: NA Device Count: 1 Device Description: Pancreatic Stent Advanix Pancreatic Stent - Device Characteristics Making a meaningful difference in patients' lives. Polymeric biliary stent, non-bioabsorbable. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. Advanix Duodenal Bend Preloaded RX Stent Systems 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. Please contact our technical team for additional support. 0000003169 00000 n
Fully covered stent is designed for removal up to 12 months post-placement. 0000010863 00000 n
Information given here is checked thoroughly by "Implant-Register". Disclaimers 0000003127 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. 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. <]>>
K203162. In the United States, the WallFlex Biliary RX Fully Covered Stent System RMV is cleared for indwell up to 12 months in the treatment of benign biliary strictures secondary to chronic pancreatitis. ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. Stents are not a magnetic resonance imaging (MRI) contrast medium. 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. 1.5: Safe More. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. The sternt lengths for each diameter vary from 5cm-l 8cm stent lengths. 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. * Compatible with Boston Scientific .035" guidewires, including Dreamwire. 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. 0000005940 00000 n
* Compatible with Boston Scientific .035" guidewires, including DreamwireGuidewire. 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. The four fluoroscopy markers and yellow transition zone are designed to help aid in stent placement accuracy when deployed using endoscopic visualization. All trademarks are property of their respective owners. All images taken by Boston Scientific. By clicking Accept you confirm your understanding and acceptance of the statements of this disclaimer. Prior to use, please consult device labeling for prescriptive information and operating instructions. startxref
These stents may be used with short or long guidewires. 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. PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS. - 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 . 0000001521 00000 n
We have had confirmation from the surgical team that within the following sites: GRI, RAH and QEUH MR Conditional biliary stents are used. 0000194891 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. 0000000016 00000 n
The RX biliary delivery system is reconstrainable up to 80% of deployment to aid in repositioning*** and is designed to facilitate physician control. 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.
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2022 Boston Scientific Corporation. Gastrointestinal Endoscopy, 2006; 63: 986-995. 1. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2, Flexibility Maple Grove, M. 3: Safe More. 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. Biliary Stent BOSTON SCIENTIFIC CORPORATION. Below please find ordering information for WallFlex Biliary RX Stents. 4. Shape Diameter (Fr) Length (cm) Package Quantity Request Pricing Product Documentation Instructions for Use 0000006584 00000 n
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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. MRI Safety Status: MR Safe: Human Cell/Tissue Product: false: Device Kit: false: Device Combination Product: The indications for pancreatic stent implantation are either prophylactic or 0000016595 00000 n
Applicant Contact. Documents Clinical Resource The fully covered stent is indicated for indwell up to 12 months after placement in benign biliary strictures secondary to chronic pancreatitis. 0000002795 00000 n
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The delivery system consists of a guide catheter and outer push catheter. Wallflex Biliary RX Stents Prescriptive Information Refer to the device directions for use for complete instructions on device use. The safety and effectiveness of the WallFlex Biliary RX Fully Covered Stent System RMV for use in the vascular system has not been established. Drainage holes are positioned every 5mm at 90 degree intervals to support drainage and patency. 0000032705 00000 n
Boston Scientific M00534330 Advanix Duodenal Bend Preloaded Biliary Stent with NaviFlex RX Delivery System 10F x 7cm. 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 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. Premarket Submission Number Not Available/Not Released, Device Size Text, specify: 3.3 mm Stent Diameter, Device Size Text, specify: 7 cm Effective Length, Device Size Text, specify: 10 F Stent Diameter. FDA.report GUDID BOSTON SCIENTIFIC CORPORATION 08714729786825. Testing of overlapped stents has not been conducted. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. Platinol Wire construction provides flexibility to help aid placement in tortuous anatomies.*. 2023 Boston Scientific Corporation or its affiliates. 0000006007 00000 n
*** A stent cannot be reconstrained after the reconstrainment line has been exceeded 99 40
Boston Scientific Advanix biliary stents win FDA, CE mark . and QEUH departments. 3: Safe More. Question - Answer 0. 0
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. DISCLAIMERS: Please note that access to certain information on the following pages is intended for healthcare professionals. Boston Scientific is offering a Patency Satisfaction Program for covered and partially covered WallFlex Stents. Post date June 29, 2022; Categories In words to describe your personal identity; name a creature that invades your home family feud . 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. To sale by or on the order of a physician sequences per are... Quot ; Implant-Register & quot ; RX stents prescriptive information REFER to the labeling for a MORE LIST... 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