The VICI SDS and VICI RDS VENOUS STENT Systems are intended for the treatment of obstructions and occlusions in the narrowed or blocked venous veins. Marlborough, MA 01752-1566 . Search for coronary and peripheral disease and valve disease IFUS. As the stent is exposed to body temperature it expands to appose the duct wall. Coils, stents, filters and vascular grafts have been evaluated relative to the use of MR systems. Coils, Filters, Stents, and Grafts More. This site is Exclusively Sponsored by BRACCO. Boston Scientific performed rigorous laboratory testing to demonstrate MRI compatibility. Proper patient monitoring must be provided during the MRI scan. Newmatic Medical, www.newmaticmedical.com. Many of our pacemakers (leadless and traditional), ICDs, ICMs, CRT-Ds, CRT-Ps, pressure sensors, heart valves, occluders and annuloplasty rings are MR Conditional. 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. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements.
Device setup, user manuals and troubleshooting, (April 5, 2005) -- Boston Scientific Corporation (NYSE: BSX) today announced that the U.S. Food and Drug Administration (FDA) has approved enhancements to the Directions for Use (DFU) of the TAXUS Express, 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. @Bd!$7@"rAOgx
There have been 17 complaints and reported injuries related to this issue. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. We recommend that you download and review the most current version any time a patient with an Abbott product needs an MRI. For more information, please visit: www.bostonscientific.com. AccessGUDID - Ascerta Firm (08714729861720)- Ureteral Stent. With our stent systems, MRI analyses can now be performed immediately.". Boston Scientific 2 Agenda I. 86 0 obj
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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). The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Illustrations are artist's representations only and should not be considered as engineering drawings or photographs.
Boston Scientific Sentinol Self-Expanding Nitinol Biliary Stent System with Over-the-Wire Delivery System. Data from the first human use NG PROMUS Clinical Trial evaluating the safety and effectiveness of the Promus PREMIER Everolimus-Eluting . Coils, Filters, Stents, and Grafts More. Our ability to provide a total iliac solution, with the market-leading Express LD Stent and our expansive balloon catheter portfolio, allows Boston Scientific to offer a complete line of advanced solutions to physicians and patients.". 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. The MRI parameter settings are selected at the physician's discretion. 38948-8607. HWnFC=ji6n
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9x?pFH=@q}+[|Gd $Xp7lXcV5ZID?vM1V]kM).? The ORION clinical data was used to support application for U.S. Food and Drug Administration approval of the Epic Stent System. The delivery system is compatible with 0.035 in. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual for additional details about patient monitoring. A non-bioabsorbable tubular device intended to be implanted in the common and/or external iliac artery (ies) to maintain arterial patency and luminal diameter in patients with symptomatic atherosclerotic disease. The Merlin PCS Programmer will print to the default printer (internal printer, external printer or PDF). Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. %%EOF
The Notice described the issue, identified affected product and asked that the use of affected product be discontinued and affected units be segregated.
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To look up your patients system, use the Product Search tool to determine whether your patients device and leads (if applicable) are safe for an MRI. A non-bioabsorbable tubular device intended to be implanted in the common and/or external iliac artery(ies) to maintain arterial patency and luminal diameter in patients with symptomatic atherosclerotic disease. Refer to the manuals for CardioMEMS HF System or MR Conditional ICMs for details about MRIs with those devices. Several of these demonstrated magnetic field interactions. 1) Confirm MRI readiness. endstream
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Are you a healthcare professional? 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." [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. The C-code used for this product is C1876, Stent, non-coated/non-covered with delivery system. About Epic and the ORION Trial The Epic Stent is a self-expanding nitinol stent designed to sustain vessel patency, while providing enhanced visibility and accuracy during placement. 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. The Sentinol Nitinol Stent System is comprised of two components: the implantable endoprosthesis and the stent delivery system. "The performance of the Epic Stent in challenging iliac artery lesions and the long-term demonstration of both safety and efficacy of the Epic Stent is another example of our ability to offer patients a durable treatment option for iliac artery disease.". The product, pouch label and carton label are all correct and the correct DFU is in the package. Follow the checklist instructions within Merlin PCS Programmer. It is required to program the device to MRI Settings as part of the MRI scan workflow. Overview of the ELUVIA Drug- Eluting Stent (DES) III. This cautionary statement is applicable to all forward-looking statements contained in this document. "Following the recent presentation of our nine-month data, the 12-month ORION data continue to show very strong clinical outcomes," said Dr. Clair. Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words. Date of Panel Recommendation: None Premarket Approval Application (PMA) Number: P150003/S058 Date of FDA Notice of Approval: August 10, 2020 %PDF-1.5
%
Conditional 6 More. Platinum Chromium Coronary Stent System (Monorail) Device Procode: Applicant's Name and Address: NIQ . Alternatively, you can also use the latest MRI Manuals to determine scan parameters. Instructions for Downloading Viewers and Players. Note: Boston Scientific is not responsible for the correct use of codes on submitted claims; this informationdoes not constitute reimbursement or legal advice. "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. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. A Recall Notice, dated 05/14/04, was sent to appropriate hospital personnel. Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX. Class 3 Device Recall Sentinol Nitinol Biliary Stent System. 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. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. The following pages are intended for medical professionals and provide information on the proper use of products (medical devices, etc.) 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. 3: Conditional 6 . Our manuals contain the latest instructions and information for cardiac physicians, radiologists and MR technologists. The TAXUS Express2 and Express2 systems were shown to be MRI safe at a high level of magnetic field strengths with minimal effect on temperature rise and drug release. of Abbott Medical Japan GK. Due to the use of intense magnetic fields in MRI examinations, implanted medical devices that contain metal may be subject to potential migration and heating within the body. ,TFZ3R?ZU,6P;0rY;qC\#*"zgZ71j:clLv^O LHf,xvU8pZ7 9^FHZ|+iL V~G!=}6. 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. Precautions
It was launched in the United States in May of 2012. For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file hereafter. The Sentinol Nitinol Stent System is comprised of two components: the implantable . The FDA has identified this as a Class I recall, the most serious type of recall. }7MWJ!%c. "The positive 12-month data from the ORION trial complement our early launch success and market share gains," said Jeff Mirviss, president of Peripheral Interventions at Boston Scientific. f@ hbbd``b` C9E tk`/@PHA,HyM! The TAXUS stent system is the first drug-eluting stent to receive approval for immediate post-procedure MRI. Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . 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 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. The delivery system is of coaxial design with an exterior shaft to protect and constrain the stent prior to deployment. Safety Topic / Subject Enterra II Model 37800 Gastric Electrical Stimulation (GES) System . {}(;]xjx$,&\I'esU7;O*G@MI9YO?V6t N=9nq}^I pk2f5RVw>bd.Ms@G7'^,UPX_4~KO$rS8ILEn5WVu >V:RD/L u 9cwM\^$h IOK
#>of=eP
V}-St:Ur{>J;{n=b^mZ? All rights reserved. All rights reserved. From the FastPath Summary screen, select the Print button to print the Diagnostics and any other relevant reports. 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 [?] An official website of the United States government, : You can search by model number or product category. This stent has not been evaluated to determine if it is MR Conditional beyond these conditions. Boston Scientific Sentinol Self-Expanding Nitinol Biliary Stent System with Over-the-Wire Delivery System. The site is secure. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. The information provided here is not intended to provide information to patients and the general public. This site is Exclusively Sponsored by BRACCO, ENTERRA THERAPY, Gastric Electrical Stimulation (GES), Neurostimulation System, Orthopedic Implants, Materials, and Devices, Cerebrospinal Fluid (CSF) Shunt Valves and Accessories, Hemostatic Clips, Other Clips, Fasteners, and Staples. Safe More. Magnetic Resonance Imaging (MRI) Safety for Boston Scientific Peripheral Products PDF, 272.0 KB. We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. 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. This includes continuous monitoring of the patient's hemodynamic function. 7th.Ine!Y+mOTqDm/`*XBagB8GzXov8P1zluIz y "0!rab/dMwLtX1@_18TUWW\ T/~dc/mRE Fortunately, the devices that exhibited po . 510(K)s with Product Code = FGE and Original Applicant = BOSTON SCIENTIFIC CORP. The positive data support the Boston Scientific goal of delivering products designed to reduce the need for reinterventions and help lower overall healthcare costs. Immediately following the MRI procedure, follow the instructions in the MRI Ready Systems Manual or MRI Ready Leadless System Manual to revert to the permanently programmed settings. The prospective, single-arm ORION trial enrolled 125 patients at 28 sites in the United States. 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. Refer to the . About Boston ScientificBoston Scientific is a worldwide developer, manufacturer and marketer of medical devices that are used in a broad range of interventional medical specialties. 1.5,3: Conditional 5 More . 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. 2023 Boston Scientific Corporation or its affiliates. Magnetic Resonance MR Conditional 3.0 tesla temperature information Results were presented today by Daniel Clair, M.D., FACS, principal investigator of the . Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 2022 Boston Scientific Corporation or its affiliates. May be removed prior to MRI and replaced after the MRI exam. 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 [?] 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: These forward-looking statements include, among other things, statements regarding our business plans, clinical trials and outcomes, our technology, product performance and importance, and competitive offerings. 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. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. [N-'u,uDQOUyUInFl
yO/'wjGs1lx"O88KT9/vjTn ]Y~k\}C ? Patients experienced significant clinical improvement from baseline to twelve months based on feedback from validated questionnaires evaluating walking distance, speed and stair climbing. The trial previously met its primary endpoint of major adverse events (MAE) at nine months with a rate of 3.4 percent for the Epic Stent compared to a pre-specified performance goal. Within US to KY, MA, NC, NH, NJ, PA, TX, VA, WA. One lot of one catalog number of the Sentinol Nitinol Biliary Stent System may have been packaged in a Sentinol nitinol Vascular outer carton. The stent is a laser cut self-expanding stent composed of a nickel titanium alloy(nitinol). Sterile. Find out who we are, explore careers at the company, and view our financial performance. 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. Cautionary Statement Regarding Forward-Looking Statements. Note: If you need help accessing information in different file formats, see
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