This site uses cookies. Catalog No. 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. Be sure to check the lead combination(s) (if applicable) to ensure you select the correct settings. When ready to be implanted, the stent is deployed by retracting the exterior shaft of the delivery system. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review how data will be handled by each system. (0.89mm) guidewires. The revised Express2 bare-metal stent DFU will be available shortly. Once you have completed the checklist, select the Program MRI Settings button to enable MRI Settings. 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 Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. MRI Safety Home 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. The Express 2 Monorail and Over-the-Wire Coronary Stent Systems have not yet been marketed in any country. 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 Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Furthermore, outcomes for very complex (TASC C/D) lesions were similar to those reported for less complex (TASC A/B) lesions. 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. Boston Scientific, www.bostonscientific.com . %PDF-1.4
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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. "The Epic Stent is a novel stent platform designed to offer both acute and clinical advantages over older-generation stent systems. Precautions
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." The site is secure. Can I undergo MRI or scanner testing with a stent? If a device is not shown in the list, it is not MR Conditional. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. 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: 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 [?] :V
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_R]O%[D8Y}[1HshY$7\. 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. THE List - MRI Safety Epic Vascular Self-Expanding Stent System - Boston Scientific ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. 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. 1.5,3: Conditional 5 More . No amputations were reported through the 12-month period. It may be a continuous tube or a mesh structure in tubular form and is available in a variety of lengths and diameters. Patients experienced significant clinical improvement from baseline to twelve months based on feedback from validated questionnaires evaluating walking distance, speed and stair climbing. 38948-8607. An inner shaft, with two radiopaque markers, aids in the placement of the stent. Magnetic Resonance Imaging (MRI) Safety for Boston Scientific Peripheral Products PDF, 272.0 KB. "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.". If needed, perform capture and sense and lead impedance tests. It was launched in the United States in May of 2012. Boston Scientific Epic Stent Demonstrates Positive Clinical Outcomes The Boston Scientific ELUVIA Drug-Eluting Vascular Stent System is a medical device containing an ancillary medicinal substance, which provides a mechanical scaffold for vascular lumen support (the stent component) and a pharmacological agent (paclitaxel) targeted towards reducing the injury response that leads to restenosis after The Express Coronary Stent System was granted approval by Boston Scientific's notified body (TUV Rheinland) to permit CE marking June 18, 2001. If the stent migrates to the heart, it could cause life-threatening injury. 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. Illustrations are artist's representations only and should not be considered as engineering drawings or photographs. By using this site, you consent to the placement of our cookies. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by 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. Conditional 6 More. Esophageal Stent, Niti-S & Comvi Model E2423 TaeWoong Medical Co., Ltd., www.stent.net. 2022 Boston Scientific Corporation or its affiliates. MRI Safety for Cardiovascular Products I Abbott PDF 2 7 2 Epic Vascular 2 - Boston Scientific 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. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. AccessGUDID - DEVICE: Ascerta Firm (08714729861775) 86 0 obj
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Sterile. 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. Coronary data supports safety of paclitaxel and ELUVIA DES IV. 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). Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537 1.888.272.1001 www.BostonScientific.com . Coils, stents, filters and vascular grafts have been evaluated relative to the use of MR systems. 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. Overview of the ELUVIA Drug- Eluting Stent (DES) III. 3: Conditional 6 . Cautionary Statement Regarding Forward-Looking Statements. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Introduction II. 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. Fortunately, the devices that exhibited po . All rights reserved. "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. 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. GMDN Names and Definitions: Copyright GMDN Agency 2015. The following pages are intended for medical professionals and provide information on the proper use of products (medical devices, etc.) Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Orthopedic Implants, Materials, and Devices More. Class 3 Device Recall Sentinol Nitinol Biliary Stent System. Proper patient monitoring must be provided during the MRI scan. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. 0
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