Boston Scientific Sentinol Self-Expanding Nitinol Biliary Stent System with Over-the-Wire Delivery System. Coils, Filters, Stents, and Grafts More. 1.5,3: VICI VENOUS STENT System (VICI SDS) and VICI RDS VENOUS STENT System Models and Serial Numbers: See Medical Device Recall Database Entry Distribution Dates: September 21, 2018 to April 9, 2021 The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. You can search by model number or product category. 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. 2023 Boston Scientific Corporation or its affiliates. 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 of coaxial design with an exterior shaft to protect and constrain the stent prior to deployment. IFbj.)D^7TE.V\Bz->/. 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. Abbotts MRI-Ready High Voltage Device Setup for Gallant and Entrant ICD and CRT-Ds (11:45). 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. :V
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_R]O%[D8Y}[1HshY$7\. Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. An official website of the United States government, : Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual for additional details about patient monitoring. Interrogate the device with the Merlin PCS Programmer and Aveir Link Module. 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 constrained within a 6F delivery system. This includes continuous monitoring of the patient's hemodynamic function. This site is Exclusively Sponsored by BRACCO. An inner shaft, with two radiopaque markers, aids in the placement of the stent. Based on the country you select, you can choose the device and lead combination (if applicable) to get scan parameters. The following pages are intended for medical professionals and provide information on the proper use of products (medical devices, etc.) A stent delivery system for a balloon expandable stent consists Results were presented today by Daniel Clair, M.D., FACS, principal investigator of the ORION trial and chairman of the Department of Vascular Surgery at The Cleveland Clinic Foundation, at the 24th Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation. All other trademarks are the property of their respective owners. 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 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. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and may be inserted with a balloon catheter which causes . Find out who we are, explore careers at the company, and view our financial performance. GMDN Names and Definitions: Copyright GMDN Agency 2015. 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. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. The delivery system is compatible with 0.035 in. Fortunately, the devices that exhibited po, 2D Helical, 35 Fibered Platinum Coil. 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. Conditional 6 More.
Cautionary Statement Regarding Forward-Looking Statements. For information, visit MagneticResonanceSafetyTesting.com 2022 MRI Textbook 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. ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. "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. 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. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review a list of adverse conditions and effects. We recommend that you download and review the most current version any time a patient with an Abbott product needs an MRI. 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 [?] Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. All rights reserved. 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. Indicates a third party trademark, which is property of its respective owner. f@ Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537 1.888.272.1001 www.BostonScientific.com . The information provided here is not intended to provide information to patients and the general public. Use this database for coronary intervention, peripheral intervention and valve repair products. 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. 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. Based on the country you select, you can choose the device and lead combination (if applicable) to get scan parameters. HWnFC=ji6n
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9x?pFH=@q}+[|Gd $Xp7lXcV5ZID?vM1V]kM).? Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. "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. Safety Topic / Subject Enterra II Model 37800 Gastric Electrical Stimulation (GES) System . 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. The site is secure. 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. 300 Boston Scientific Way . C-codesare used for hospital outpatient device reporting for Medicare and some private payers. Read our privacy policy to learn more. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. endstream
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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. Coils, Filters, Stents, and Grafts More. 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. No deaths have been reported. The Sentinol Nitinol Stent System is comprised of two components: the implantable . The Notice described the issue, identified affected product and asked that the use of affected product be discontinued and affected units be segregated. The prospective, single-arm ORION trial enrolled 125 patients at 28 sites in the United States. Many of our pacemakers (leadless and traditional), ICDs, ICMs, CRT-Ds, CRT-Ps, pressure sensors, heart valves, occluders and annuloplasty rings are MR Conditional. Before sharing sensitive information, make sure you're on a federal government site. Boston Scientific is recalling the VICI SDS and RDS VENOUS STENT Systems after reports indicate that the stents may migrate or move from where they are initially implanted. "The Epic Stent has been very well-received by physicians across the country. Made in USA 5905 Nathan Lane, Plymouth, MN 55442, USA. Overview of the ELUVIA Drug- Eluting Stent (DES) III. For more information, please visit: www.bostonscientific.com. endstream
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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.". 121 0 obj
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Stent delivery system (SDS): A system that delivers a biliary stent to a target site within the bile duct and then deploys the stent. 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). Note: If you need help accessing information in different file formats, see
Our manuals contain the latest instructions and information for cardiac physicians, radiologists and MR technologists. 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. 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. 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. It was launched in the United States in May of 2012. The Merlin PCS Programmer will print to the default printer (internal printer, external printer or PDF). This cautionary statement is applicable to all forward-looking statements contained in this document. 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. Class 3 Device Recall Sentinol Nitinol Biliary Stent System. Fortunately, the devices that exhibited po . ,TFZ3R?ZU,6P;0rY;qC\#*"zgZ71j:clLv^O LHf,xvU8pZ7 9^FHZ|+iL V~G!=}6. Use of these devices may cause serious injuries or death. The stent is a laser cut self-expanding stent composed of a nickel titanium alloy(nitinol). [N-'u,uDQOUyUInFl
yO/'wjGs1lx"O88KT9/vjTn ]Y~k\}C ? Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. NOTE: Device diagnostic data may be suspended or cleared when MRI Settings are enabled. The Express Coronary Stent System was granted approval by Boston Scientific's notified body (TUV Rheinland) to permit CE marking June 18, 2001. Newmatic Medical, www.newmaticmedical.com. Boston Scientific performed rigorous laboratory testing to demonstrate MRI compatibility. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements. Refer to the manuals for CardioMEMS HF System or MR Conditional ICMs for details about MRIs with those devices. This site uses cookies. 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. Factors that may cause such differences include, among other things: future economic, competitive, reimbursement and regulatory conditions; new product introductions; demographic trends; intellectual property; litigation; financial market conditions; and future business decisions made by us and our competitors. 7th.Ine!Y+mOTqDm/`*XBagB8GzXov8P1zluIz y "0!rab/dMwLtX1@_18TUWW\ T/~dc/mRE 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. Catalog No. 2022 Boston Scientific Corporation or its affiliates. Magnetic Resonance Imaging (MRI) Safety for Boston Scientific Peripheral Products PDF, 272.0 KB. The .gov means its official.Federal government websites often end in .gov or .mil. 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. As a result, DFUs for stent systems containing metal usually recommend a waiting period of approximately two months from the time of implantation until an MRI can be performed safely. Physicians interested in reviewing a complete copy of the revised TAXUS Express2 stent DFU may obtain a copy from the TAXUS website at www.taxus-stent.com. 1) Confirm MRI readiness. MRI is an effective method of providing detailed diagnosis for many types of injuries and conditions, including cardiovascular disease. The Sentinol Nitinol Stent System is comprised of two components: the implantable endoprosthesis and the stent delivery system. Unless otherwise specified, all product names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. All rights reserved. The revised Express2 bare-metal stent DFU will be available shortly. 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. Proper patient monitoring must be provided during the MRI scan. 0
If a device is not shown in the list, it is not MR Conditional. By using this site, you consent to the placement of our cookies. Indications for Use The Wallstent Venous Endoprosthesis is indicated for improving central venous diameter . H7YPnf'Sq-. Find products, medical specialty information, and education opportunities. This press release contains forward-looking statements. Alternatively, you can also use the latest MRI Manuals to determine scan parameters. Within US to KY, MA, NC, NH, NJ, PA, TX, VA, WA. MRI safety testing has shown that the REBEL Stent is MR Conditional and that Instructions for Downloading Viewers and Players. 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. %PDF-1.5
%
Dont scan the patient if any adverse conditions are present. BSC began marketing the product internationally following approval in September 2001. Use this database for arrhythmia, heart failure and structural heart products. 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). hbbd``b` C9E tk`/@PHA,HyM! Date of Panel Recommendation: None Premarket Approval Application (PMA) Number: P150003/S058 Date of FDA Notice of Approval: August 10, 2020 Device Size Text, specify: 75 cm Effective Length, Device Size Text, specify: 40 mm Stent Length, Device Size Text, specify: 10 mm Stent Diameter. 1 0 obj
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