Patients receiving coronary stents have typically been required to wait approximately two months before receiving an MRI. 38948-8607. AccessGUDID - Ascerta Firm (08714729861720)- Ureteral Stent. Boston Scientific Corporation Customer Service: 8882721001 www.bostonscientific.com Page 1 of 12 PI86716AG Magnetic Resonance Imaging (MRI) Safety for Boston Scientific Products Table of Contents 1. One lot of one catalog number of the Sentinol Nitinol Biliary Stent System may have been packaged in a Sentinol nitinol Vascular outer carton. No deaths have been reported. 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. 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. GMDN Names and Definitions: Copyright GMDN Agency 2015. These devices are considered MR Unsafe. All rights reserved. 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: Refer to the . 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. 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. 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. 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). 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. Date of Panel Recommendation: None Premarket Approval Application (PMA) Number: P150003/S058 Date of FDA Notice of Approval: August 10, 2020 1.5 . 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. Introduction II. Drummond wire (316L SS) orthopedic implant. This site uses cookies. Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words. The stent is a laser cut self-expanding stent composed of a nickel titanium alloy(nitinol). "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. "The Epic Stent is a novel stent platform designed to offer both acute and clinical advantages over older-generation stent systems. 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. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. If the stent migrates to the heart, it could cause life-threatening injury. 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. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. These devices are considered MR Unsafe. ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. Boston Scientific, www.bostonscientific.com . The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Instructions for Downloading Viewers and Players. Safe More. Before sharing sensitive information, make sure you're on a federal government site. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. This stent has not been evaluated to determine if it is MR Conditional beyond these conditions. 121 0 obj <>stream 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. It may be a continuous tube or a mesh structure in tubular form and is available in a variety of lengths and diameters. MR imaging provides excellent spatial . 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. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Interrogate the device with the Merlin PCS Programmer and Aveir Link Module. 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. The TAXUS stent system is the first drug-eluting stent to receive approval for immediate post-procedure MRI. 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. Based on the country you select, you can choose the device and lead combination (if applicable) to get scan parameters. The results found that the stent was MRI . Indicates a trademark of the Abbott group of companies. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. f@ Cautionary Statement Regarding Forward-Looking Statements. Note: If you need help accessing information in different file formats, see 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. 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. 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. Use of these devices may cause serious injuries or death. This cautionary statement is applicable to all forward-looking statements contained in this document. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Many of our pacemakers (leadless and traditional), ICDs, ICMs, CRT-Ds, CRT-Ps, pressure sensors, heart valves, occluders and annuloplasty rings are MR Conditional. The delivery system is compatible with 0.035 in. BSC began marketing the product internationally following approval in September 2001. "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. DVAz~U|OH_P&xuN)Z6:U<0GI+LQj%]mr2&4SCjyWlQq0H[-2vmu5*Q]zp`MocdS.I>^fp~DEBdo(t This scientific statement is intended to summarize and clarify issues regarding the safety of MR imaging in patients with cardiovascular devices. :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\. Indications for Use The Wallstent Venous Endoprosthesis is indicated for improving central venous diameter . 2023 Boston Scientific Corporation or its affiliates. Esophageal Stent, Niti-S & Comvi Model E2423 TaeWoong Medical Co., Ltd., www.stent.net. Refer to the manuals for CardioMEMS HF System or MR Conditional ICMs for details about MRIs with those devices. May be removed prior to MRI and replaced after the MRI exam. If needed, perform capture and sense and lead impedance tests. The prospective, single-arm ORION trial enrolled 125 patients at 28 sites in the United States. The MAE rate at 12 months was 5.4 percent, with all MAEs related to TVR. 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 [?] 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. From the FastPath Summary screen, select the Print button to print the Diagnostics and any other relevant reports. MRI is an effective method of providing detailed diagnosis for many types of injuries and conditions, including cardiovascular disease. Please be sure to read it. 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. 1.5,3: Indicates a third party trademark, which is property of its respective owner. This site is Exclusively Sponsored by BRACCO. The Express Coronary Stent System was granted approval by Boston Scientific's notified body (TUV Rheinland) to permit CE marking June 18, 2001. Safety Topic / Subject Enterra II Model 37800 Gastric Electrical Stimulation (GES) System . 7th.Ine!Y+mOTqDm/`*XBagB8GzXov8P1zluIz y "0!rab/dMwLtX1@_18TUWW\ T/~dc/mRE The information provided here is not intended to provide information to patients and the general public. No amputations were reported through the 12-month period. Note: Boston Scientific is not responsible for the correct use of codes on submitted claims; this informationdoes not constitute reimbursement or legal advice. The C-code used for this product is C1876, Stent, non-coated/non-covered with delivery system. Fortunately, the devices that exhibited po, 2D Helical, 35 Fibered Platinum Coil. Patients experienced significant clinical improvement from baseline to twelve months based on feedback from validated questionnaires evaluating walking distance, speed and stair climbing. "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. Boston Scientific performed rigorous laboratory testing to demonstrate MRI compatibility. Catalog No. The Merlin PCS Programmer will print to the default printer (internal printer, external printer or PDF). Boston Scientific 2 Agenda I. 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. For more information, please visit: www.bostonscientific.com. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 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. The Notice described the issue, identified affected product and asked that the use of affected product be discontinued and affected units be segregated. Precautions 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. 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. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and may be inserted with a balloon catheter which causes . Within US to KY, MA, NC, NH, NJ, PA, TX, VA, WA. Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . ,TFZ3R?ZU,6P;0rY;qC\#*"zgZ71j:clLv^O LHf,xvU8pZ7 9^FHZ|+iL V~G!=}6. The Sentinol Nitinol Stent System is comprised of two components: the implantable . The site is secure. An official website of the United States government, : Coils, Filters, Stents, and Grafts More. 300 Boston Scientific Way . This includes continuous monitoring of the patient's hemodynamic function. Dont scan the patient if any adverse conditions are present. 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. 3: Conditional 6 . Furthermore, outcomes for very complex (TASC C/D) lesions were similar to those reported for less complex (TASC A/B) lesions. 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. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review a list of adverse conditions and effects. For information, visit MagneticResonanceSafetyTesting.com 2022 MRI Textbook 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 [?] Use this database for coronary intervention, peripheral intervention and valve repair products. 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. You can search by model number or product category. Boston Scientific's Express 2 (bare-metal) stent system also received approval for immediate MRI exams. CAUTION: These products are intended for use by or under the direction of a physician. 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. 38948-8607. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. You can search by product, model number, category or family. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements. Newmatic Medical, www.newmaticmedical.com. 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. Results were presented today by Daniel Clair, M.D., FACS, principal investigator of the . 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. There have been 17 complaints and reported injuries related to this issue. 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 [N-'u,uDQOUyUInFl yO/'wjGs1lx"O88KT9/vjTn ]Y~k\}C ? 0.3. With our stent systems, MRI analyses can now be performed immediately.". Can I undergo MRI or scanner testing with a stent? %PDF-1.5 % Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 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 %%EOF Sterile. Instructions for Downloading Viewers and Players, Class 3 Device Recall Sentinol Nitinol Biliary Stent System. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual for additional details about patient monitoring. Made in USA 5905 Nathan Lane, Plymouth, MN 55442, USA. of Abbott Medical Japan GK. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review a list of adverse conditions and effects. By using this site, you consent to the placement of our cookies. Once you have completed the checklist, select the Program MRI Settings button to enable MRI Settings. MRI at 3T or 1.5T may be performed immediately following the implantation of the Epic Stent. As the stent is exposed to body temperature it expands to appose the duct wall. 2022 Boston Scientific Corporation or its affiliates. Disposable devices associated with implantation may be included. 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).

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