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Date of Panel Recommendation: None Premarket Approval Application (PMA) Number: P150003/S058 Date of FDA Notice of Approval: August 10, 2020 Note: Boston Scientific is not responsible for the correct use of codes on submitted claims; this informationdoes not constitute reimbursement or legal advice. By using this site, you consent to the placement of our cookies. Follow the checklist instructions within Merlin PCS Programmer. The revised Express2 bare-metal stent DFU will be available shortly. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review a list of adverse conditions and effects. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual for additional details about patient monitoring. HWnFC=ji6n 9/~\:\$$rxnsU,)Ielo((a,$4bY?W7)MoQEHk1s-;]zXJ$G=0.F4VJYwS|U9VOU@n0ZL26w~+y38.$qW|%-zu'2g:,IwA28nvnP R%ivTpks5>/m5p)H,!HIsqz 9x?pFH=@q}+[|Gd $Xp7lXcV5ZID?vM1V]kM).? Epic is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. 0.3. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and may be inserted with a balloon catheter which causes the device to expand when inflated, or it may self-expand after insertion with a delivery device. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review a list of adverse conditions and effects. This site is Exclusively Sponsored by BRACCO. Boston Scientific Sentinol Self-Expanding Nitinol Biliary Stent System with Over-the-Wire Delivery System. "Following the recent presentation of our nine-month data, the 12-month ORION data continue to show very strong clinical outcomes," said Dr. Clair. Furthermore, outcomes for very complex (TASC C/D) lesions were similar to those reported for less complex (TASC A/B) lesions. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements. Fortunately, the devices that exhibited po . Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to check the MRI scan parameter tables for the applicable scan and identify the settings for RF Transmit Conditions and scan regions. A Boston Scientific Study of the Epic Self-Expanding Nitonol Stent System in the treatment of Atherosclerotic Lesions in Iliac Arteries 0 amputations at 3 years (106 subjects) 89.9% Freedom from TLR at 3 years (143 lesions) ORION US IDE Clinical Trial to demonstrate similar patency across all TASC classifications [prod, crx3, samplecontent, publish, crx3tar], https://vascular.abbott.com/,https://mri.merlin.net/,https://www.thelancet.com/,https://www.ahajournals.org/,https://www.onlinejacc.org/,https://jamanetwork.com/,https://www.sciencedirect.com/,https://onlinelibrary.wiley.com/,https://www.cms.gov/,https://www.novitas-solutions.com/,https://event.on24.com/,https://dx.doi.org/,https://www.myloopaccount.com/,https://www.invasivecardiology.com/,https://manuals.sjm.com/,https://www.cardiovascular.abbott, MRI Ready Systems Manual or MRI Ready Leadless System Manual, Interrogate the device with the Merlin PCS Programmer. If needed, perform capture and sense and lead impedance tests. Find products, medical specialty information, and education opportunities. Made in USA 5905 Nathan Lane, Plymouth, MN 55442, USA. Upon approval, the Epic Stent along with the market-leading Express LD balloon-expandable iliac stent, would enable Boston Scientific to offer a complete line of advanced iliac solutions for physicians and patients." Applicant's Name and Address: Boston Scientific Scimed Inc. One Scimed Place Maple Grove MN 55311-1566 PMA Number: P980033 Date of Notice of Approval to the Applicant: Novermber 16, 2001 2. of Abbott Medical Japan GK. epic vascular self-expanding stent system: Boston Scientific Corp. P110035 S045: 04/03/2018: memorygel silicone gel-filled breast implants: MENTOR CORP. P030053 S045: 01/30/2018: reflection ceramic acetabular hip system: Smith & Nephew, Inc. P030022 S045: MRI at 3T or 1.5T may be performed immediately following the implantation of the Epic Stent. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . It was launched in the United States in May of 2012. One lot of one catalog number of the Sentinol Nitinol Biliary Stent System may have been packaged in a Sentinol nitinol Vascular outer carton. On April 12, 2021, Boston Scientific Corporation sent an Urgent Medical Device Recall Notification to customers asking them to: Customers with questions should contact their Boston Scientific sales representative. 38948-8607. No deaths have been reported. 2022 Boston Scientific Corporation or its affiliates. Search for coronary and peripheral disease and valve disease IFUS. Disposable devices associated with implantation may be included. Catalog No. Medical Device Recalls, Recalls, Market Withdrawals and Safety Alerts, Boston Scientific Corporation Recalls VICI VENOUS STENT System and VICI RDS VENOUS STENT System for Potential of Stent Migration, VICI VENOUS STENT System (VICI SDS) and VICI RDS VENOUS STENT System, Distribution Dates: September 21, 2018 to April 9, 2021, Health care providers using the VICI VENOUS STENT System and VICI RDS VENOUS STENT System, Patients who have a procedure using the VICI VENOUS STENT System or VICI RDS VENOUS STENT System, Immediately discontinue use of the device, Remove all affected units from inventory and secure them, Complete the company's Verification Form to acknowledge receipt and report products that will be returned, Package affected products for shipping and contact the local Boston Scientific representative to arrange for their return. The Express Coronary Stent System was granted approval by Boston Scientific's notified body (TUV Rheinland) to permit CE marking June 18, 2001. This includes continuous monitoring of the patient's hemodynamic function. Patients receiving coronary stents have typically been required to wait approximately two months before receiving an MRI. Stent delivery system (SDS): A system that delivers a biliary stent to a target site within the bile duct and then deploys the stent. Epic Stent Boston Scientific, www.bostonscientific.com. Testing, Training, and Books Implant & Device Testing MAGNETIC RESONANCE SAFETY TESTING SERVICES is a highly experienced MRI-safety testing company that conducts comprehensive evaluations of implants, devices, objects, and materials. Following is some high-level information about preparing for and administering an MRI with patients with a leadless pacemaker, traditional pacemaker, ICD, CRT-D or CRT-P. Coils, Filters, Stents, and Grafts More. Boston Scientific's Express 2 (bare-metal) stent system also received approval for immediate MRI exams. To look up your patient's system, use the Product Search tool to determine whether your patient's device and leads (if applicable) are safe for an MRI. 59 0 obj <> endobj The .gov means its official.Federal government websites often end in .gov or .mil. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company. endstream endobj 60 0 obj <>>>/Filter/Standard/Length 128/O(v~aIgInj rM)/P -1340/R 4/StmF/StdCF/StrF/StdCF/U( ey,62_ )/V 4>> endobj 61 0 obj <>>> endobj 62 0 obj <> endobj 63 0 obj <>/ExtGState<>/Font<>/ProcSet[/PDF/Text]/Properties<>/Shading<>/XObject<>>>/Rotate 0/TrimBox[24.0 24.0 619.276 865.89]/Type/Page>> endobj 64 0 obj <>stream CAUTION: Do not bring any external control devices, such as the Merlin Patient Care System (PCS) Programmer, SJM MRI Activator handheld device, or Aveir Link Module into the scanner magnet room (Zone IV). They appreciate the radial force of the stent, which helps allow the artery to stay open, and the flexibility in its design, which helps in deliverability. Before sharing sensitive information, make sure you're on a federal government site. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. The following countries were contacted regarding the recall and all reported that no accounts had affected product in their possession: Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Hong Kong, India, Indonesia, Vietnam, New Zealand, Israel, Korea, Malaysia, Mexico, Philippines, Singapore, South Africa, Taiwan, Thailand, Turkey, Uruguay, Andean & Caaribbean Countries, Cyprus, Balkins, Puerto Rico, Bahrain, Egypt, Jordan, Kuwait, Lebanon, Morocco, Oman, Pakistan, Qatar, Saudi Arabia, Syria, Tunisia, Yemen, United Arib Emirates. Newmatic Medical, www.newmaticmedical.com. ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Based on the country you select, you can choose the device and lead combination (if applicable) to get scan parameters. As the stent is exposed to body temperature it expands to appose the duct wall. Be sure to check the lead combination(s) (if applicable) to ensure you select the correct settings. %%EOF Refer to the . Orthopedic Implants, Materials, and Devices More. The Express 2 Monorail and Over-the-Wire Coronary Stent Systems have not yet been marketed in any country. DVAz~U|OH_P&xuN)Z6:U<0GI+LQj%]mr2&4SCjyWlQq0H[-2vmu5*Q]zp`MocdS.I>^fp~DEBdo(t Results were presented today by Daniel Clair, M.D., FACS, principal investigator of the . Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729802976 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 021717889 * Terms of Use Device Description: Ureteral Stent CLOSE Device Characteristics Device Record Status Alternative and Additional Identifiers Customer Contact [?] 7th.Ine!Y+mOTqDm/`*XBagB8GzXov8P1zluIz y "0!rab/dMwLtX1@_18TUWW\ T/~dc/mRE Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537 1.888.272.1001 www.BostonScientific.com . Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. A migrated stent may require another surgery or catheter procedure to retrieve it, which increases risks to the patient, including possible damage to the blood vessel, heart walls or other organs. Based on the country you select, you can choose the device and lead combination (if applicable) to get scan parameters. A stent delivery system for a balloon expandable stent consists Are you a healthcare professional? From the FastPath Summary screen, select the Print button to print the Diagnostics and any other relevant reports. Boston Scientific, www.bostonscientific.com, 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, AAA Endograft Ovation Ovation Abdominal Stent Graft System TriVascular2, Inc. Santa Rosa, CA, Abre StentMedtronic, Inc., www.Medtronic.com/MRI, Absolute .035 Biliary Self-Expanding StentAbbott Vascular, www.abbottvascular.com, ABSOLUTE 0.35 Biliary Self Expanding Stent System Guidant http://www.guidant.com/ifu/, Absolute Biliary StentAbbott Vascularwww.abbottvascular.com, Absolute Pro .035 Biliary Self-Expanding StentAbbott Vascular, www.abbottvascular.com, Absolute Pro Peripheral Stent Abbott Vascular www.Abbott.com, Absolute Pro Stent Nickel titanium with nickel titanium platinum markers 8-mm x 120-mm Single version Abbott Vascular Santa Clara, CA, Absolute Pro Stent Nickel titanium with nickel titanium platinum markers 8-mm x 348-mm three overlapped version Abbott Vascular Santa Clara, CA, ABSOLUTE Biliary Self-Expanding Stent System Nitinol coils, filters, stents Guidant Endovascular Solutions Santa Clara, CA, Absorb Bioresorbable Vascular Scaffold (BVS) SystemAbbott Vascular, www.abbottvascular.com, Absorb GT1 Bioresorbable Vascular Scaffold (BVS) SystemAbbott Vascular,www.abbottvascular.com, Acculink Carotid StentAbbott Vascularwww.abbottvascular.com, ACCULINK Carotid StentGuidanthttp://www.guidant.com/ifu/, ACS MULTI-LINK Coronary StentAbbott Vascularwww.abbottvascular.com, ACS MULTI-LINK DUET Coronary StentAbbott Vascularwww.abbottvascular.com. Prior to use, reference the Instructions for Use, inside the product carton (when available) or online for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events. Duplex ultrasound, which measures blood flow through arteries and veins, showed a primary patency (level of un-obstruction) of 94.4 percent, indicating the vast majority of treated lesions remained open through the 12-month follow-up period. This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. "The FDA approval of the timing on MRI exams is a significant development for interventional cardiologists and their patients," said Paul LaViolette, Boston Scientific Chief Operating Officer. Precautions MRI safety testing has shown that the REBEL Stent is MR Conditional and that Enterra II Model 37800Gastric Electrical Stimulation (GES) SystemEnterra II Model 37800Medtronic, Inc., www.medtronic.com, Enterra TherapyGastric Electrical Stimulation (GES) SystemModels 3116 and 7425 GEnterra II Model 37800Medtronic, Inc., www.medtronic.com, Entovis ProMRI Cardiac Pacing SystemWhich consists of the Entovis pulse generator and the Setrox S and Safio S leadsBIOTRONIK, Inc., http://www.biotronikusa.com/manuals/index.cfmNote that the MR Condi, ENTRI-FLEXEntriFlexNasogastric (NG) Feeding TubeCOVIDIENHazelwood, MO, ENTRISTARJejunum Feeding Tube/Gastric Depression TubeCOVIDIENHazelwood, MO, EOI Spinal System EPPS (Expanding Polyaxial Pedicle Screw)Expanding Orthopedics Inc.Israel, EOS (Endoluminal Occlusion System) ImplantMedical Murray, Inc., medicalmurray.com, Epic StentBoston Scientific, www.bostonscientific.com, EpicageAlphatec Spine Inc., www.alphatecspine.com, Episealer Knee CondyleEpisurf Medical AB, www.episurf.com, Equi-Flow Valve System(s)15174, SLRKL, SLSKLL, 15175, SLRKLL,SLSKLM, 15179, SLRKLM, SLSKM, 15185,SLRKM, SLSL, 15549, SLRL, SLSLL,15551, SLRLL, SLSLM, 15552, SLRLM,SLSM, 15554, SLRM, 15181, 15555,SLSKL, Equine Pericardial Patch, Model XAGEdwards Lifesciences, www.edwards.com, EquipLite bladeTruphatek International LTD., www.truphatek.com, ES-830 MicroCutter Green StapleCardica, Inc. and Dextera Surgical, www.dexterasurgical.com, EsophaCoil-SRnitinolcoil, stent, filterIntratherapeutics, Inc.St. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review how data will be handled by each system. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729959915 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 021717889 * Terms of Use Device Description: Ureteral Stent With Side Holes 6Fx28CM CLOSE Device Characteristics Device Record Status Alternative and Additional Identifiers For information, visit MagneticResonanceSafetyTesting.com 2022 MRI Textbook Boston Scientific, www.bostonscientific.com . The following pages are intended for medical professionals and provide information on the proper use of products (medical devices, etc.) Marlborough, MA 01752-1566 . Please be sure to read it. 86 0 obj <>/Encrypt 60 0 R/Filter/FlateDecode/ID[<7D8C813C4252734AB79DD3D747A7C1DD><1D49B7B49C69E9479F78B175C988B6B0>]/Index[59 63]/Length 120/Prev 229479/Root 61 0 R/Size 122/Type/XRef/W[1 2 1]>>stream Abbotts MRI-Ready High Voltage Device Setup for Gallant and Entrant ICD and CRT-Ds (11:45). NATICK, Mass., Oct. 23, 2012 /PRNewswire/ --Boston Scientific Corporation (NYSE: BSX) reports twelve-month clinical endpoint data from the ORION trial, which demonstrated robust safety and effectiveness outcomes for the Epic Self-Expanding Nitinol Stent System in patients with obstructed iliac arteries. Boston Scientific 2 Agenda I. Boston Scientific performed rigorous laboratory testing to demonstrate MRI compatibility. NOTE: Device diagnostic data may be suspended or cleared when MRI Settings are enabled. Paul, M, Esophageal Reconstruction TubeHood Laboratories, www.hoodlabs.com, Esophageal Stent, Niti-S & Comvi Model E2423TaeWoong Medical Co., Ltd., www.stent.net, Esophageal StentHood Laboratories, www.hoodlabs.com, Esophageal TTS StentTaeWoong Medical Co., Ltd., www.stent.net, Esophagus Full-Covered StentCG BIO CO., LTD. www.cgbio.co.kr/en/. The default MRI parameter settings are automatically stored in the Abbott MR Conditional device. %PDF-1.4 % Boston Scientific wishes to caution the reader of this press release that actual results may differ from those discussed in the forward-looking statements and may be adversely affected by, among other things, risks associated with new product development and commercialization, clinical trials, intellectual property, regulatory approvals, competitive offerings, integration of acquired companies, Boston Scientific's overall business strategy, and other factors described in Boston Scientific's filings with the Securities and Exchange Commission. Device setup, user manuals and troubleshooting, The Boston Scientific Epic Stent Continues to Demonstrate Positive Clinical Outcomes for Patients with Iliac Artery Disease, Twelve-Month Data Presented at TCT 2012 Support Safety and Efficacy of Epic Stent in Iliac Stenting, 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. Find out who we are, explore careers at the company, and view our financial performance. Use this database for coronary intervention, peripheral intervention and valve repair products. %PDF-1.5 % Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual for details about checking the MRI Settings status with and without the MRI Activator handheld device. Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting, 12-month Primary Patency by TASC Classification, 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, Epic Vascular Self-Expanding Stent System, EDUCARE Medical Education and Training Courses, ADVANTICS Innovative Healthcare Solutions, Do not sell or share my personal information, 0 amputations at 3 years (106 subjects), ORION US IDE Clinical Trial to demonstrate similar patency across all TASC classifications, Tandem Architecture Stent Design features Macro, Medium and Micro Struts, as well as patented connector patternsdesigned to optimize flexibility, Hybrid Architecture Design with open- and closed-cell geometry engineered to provide flexibility and deployment uniformity, Macro and Micro Struts are engineered to work in tandem for balanced forceeven in tortuous vasculature, Ergonomic handle with two convenient deployment options: thumb wheel and pull grip, Radiopaque stent markers and catheter shaft marker band enhance visibility and simplify placement, Meticulous surface finishing and polishing to remove imperfections and improve fracture resistance, Tandem Architecture Stent Design engineered to bend and flex and reduce the risk of fracture, 0% Amputation of index limb at 12-months (0/111). Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. There have been 17 complaints and reported injuries related to this issue. PARIS, May 22, 2013 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) reports positive results from two trials evaluating new, innovative drug-eluting stent (DES) technologies, which are emerging treatment options for coronary heart disease. 300 Boston Scientific Way . Indicates a third party trademark, which is property of its respective owner. You can search by product, model number, category or family. Made in USA 5905 Nathan Lane, Plymouth, MN 55442, USA. Coils, Filters, Stents, and Grafts More. The stent is constrained within a 6F delivery system. AccessGUDID - Ascerta Firm (08714729861720)- Ureteral Stent. If a device is not shown in the list, it is not MR Conditional. Major adverse events are defined as death within 30 days, myocardial infarction (MI, or heart attack) occurring during hospitalization, target vessel revascularization (TVR) through nine months and amputation of the treated limb through nine months. Indicates a trademark of the Abbott group of companies. GMDN Preferred Term Name GMDN Definition; Polymeric ureteral stent A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed ureter (e.g., from stone, stricture, compression, fibrosis, trauma) to maintain luminal patency allowing urine to drain from the renal pelvis to the bladder. :V m_C.4c9M/:4"Pp^8r_h_(2KDz]H4{T["y&7xPWe8Iw]rp%c2D|t-++@n 6j.#C\Ks _R]O%[D8Y}[1HshY$7\. Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729861775 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 021717889 * Terms of Use Device Description: Ureteral Stent CLOSE Device Characteristics Device Record Status Alternative and Additional Identifiers Customer Contact [?] The positive data support the Boston Scientific goal of delivering products designed to reduce the need for reinterventions and help lower overall healthcare costs. @Bd!$7@"rAOgx The Sentinol Nitinol Stent System is comprised of two components: the implantable . Catalog No. Proper patient monitoring must be provided during the MRI scan. Several of these demonstrated magnetic field interactions. Conditional 6 More. GMDN Names and Definitions: Copyright GMDN Agency 2015. The delivery system is compatible with 0.035 in. Patients experienced significant clinical improvement from baseline to twelve months based on feedback from validated questionnaires evaluating walking distance, speed and stair climbing. Safety Info ID# Safety Topic / Subject Article Text 171: Coils, Filters, Stents, and Grafts: Coils, stents, filters and vascular grafts have been evaluated relative to the use of MR systems. The information provided here is not intended to provide information to patients and the general public. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and may be inserted with a balloon catheter which causes . The stent is a laser cut self-expanding stent composed of a nickel titanium alloy(nitinol). Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to see examples of checklist screens and get additional details about the checklist. Unless otherwise specified, all product names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. Introduction II. This press release contains forward-looking statements. Ideal for the Iliac: The Epic Stent is a self-expanding Nitinol stent designed to sustain vessel patency, while providing enhanced visibility and accuracy during placement. The MRI parameter settings are selected at the physician's discretion. Use this database for arrhythmia, heart failure and structural heart products. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. The MAE rate at 12 months was 5.4 percent, with all MAEs related to TVR. "Patients undergoing stent procedures can now avoid the long waiting period previously required before receiving MRI diagnostics during the most critical stage of their recovery. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. Class 3 Device Recall Sentinol Nitinol Biliary Stent System. If you are not using the MRI Activator, MRI Settings must be disabled by the patient's device management physician or clinician using the Merlin PCS Programmer and Aveir Link Module (if applicable). If the stent migrates to the heart, it could cause life-threatening injury. All rights reserved. Safety Topic / Subject Enterra II Model 37800 Gastric Electrical Stimulation (GES) System . Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. When ready to be implanted, the stent is deployed by retracting the exterior shaft of the delivery system. Search for arrhythmia, heart failure and structural heart IFUs. hbbd``b` C9E tk`/@PHA,HyM! It employs an innovative Tandem Architecture, which is engineered to provide excellent stent flexibility while maintaining predictable radial force characteristics across a variety of stent sizes. These devices are considered MR Unsafe. Reproduced with Permission from the GMDN Agency. The results found that the stent was MRI . Dont scan the patient if any adverse conditions are present. Coils, stents, filters and vascular grafts have been evaluated relative to the use of MR systems.