Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review a list of adverse conditions and effects. 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 Introduction II. BSC began marketing the product internationally following approval in September 2001. Indicates a trademark of the Abbott group of companies. 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. 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. 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. Catalog No. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and may be inserted with a balloon catheter which causes . Alternatively, you can also use the latest MRI Manuals to determine scan parameters. Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537 1.888.272.1001 www.BostonScientific.com . There have been 17 complaints and reported injuries related to this issue. 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). Sterile. Patients experienced significant clinical improvement from baseline to twelve months based on feedback from validated questionnaires evaluating walking distance, speed and stair climbing. 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 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. Many of our pacemakers (leadless and traditional), ICDs, ICMs, CRT-Ds, CRT-Ps, pressure sensors, heart valves, occluders and annuloplasty rings are MR Conditional. This site uses cookies. Data from the first human use NG PROMUS Clinical Trial evaluating the safety and effectiveness of the Promus PREMIER Everolimus-Eluting . The Boston Scientific Epic Stent Continues to Demonstrate Positive 2022 Boston Scientific Corporation or its affiliates. H7YPnf'Sq-. 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 review a list of adverse conditions and effects. Advances in magnetic resonance (MR) imaging and MR angiography over the last 2 decades have led to MR becoming an increasingly attractive imaging modality. 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. 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. Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. 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. Boston Scientific, www.bostonscientific.com . Boston Scientific performed rigorous laboratory testing to demonstrate MRI compatibility. 2022 Boston Scientific Corporation or its affiliates. Read our privacy policy to learn more. All rights reserved. This includes continuous monitoring of the patient's hemodynamic function. of Abbott Medical Japan GK. %%EOF No deaths have been reported. :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\. %PDF-1.4 % 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. Dry Pad 9 x 9 with Silver Antimicrobial Agent. 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. 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." Newmatic Medical, www.newmaticmedical.com. If a device is not shown in the list, it is not MR Conditional. Indicates a third party trademark, which is property of its respective owner. 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. We recommend that you download and review the most current version any time a patient with an Abbott product needs an MRI. Be sure to check the lead combination(s) (if applicable) to ensure you select the correct settings. Please be sure to read it. 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 [?] 3: Conditional 6 . Instructions for Downloading Viewers and Players. 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. This scientific statement is intended to summarize and clarify issues regarding the safety of MR imaging in patients with cardiovascular devices. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Safety of Magnetic Resonance Imaging in Patients With - Circulation Find out who we are, explore careers at the company, and view our financial performance. Fortunately, the devices that exhibited po . 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 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. Use this database for arrhythmia, heart failure and structural heart products. AccessGUDID - DEVICE: Ascerta (08714729802976) An inner shaft, with two radiopaque markers, aids in the placement of the stent. It may be a continuous tube or a mesh structure in tubular form and is available in a variety of lengths and diameters. Marlborough, MA 01752-1566 . 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. Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words. A tracking/verification form is asked to be returned to Boston Scientific and arrangements will be made for retuning the affected product. Overview of the ELUVIA Drug- Eluting Stent (DES) III. Boston Scientific 2 Agenda I. Magnetic Resonance MR Conditional 3.0 tesla temperature information "The Epic Stent is a novel stent platform designed to offer both acute and clinical advantages over older-generation stent systems. This site is Exclusively Sponsored by BRACCO. Coils, Filters, Stents, and Grafts More. Class 3 Device Recall Sentinol Nitinol Biliary Stent System Boston Scientific Epic Stent Demonstrates Positive Clinical Outcomes Cautionary Statement Regarding Forward-Looking Statements. 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. Magnetic Resonance Imaging (MRI) Safety for Boston Scientific Peripheral Products PDF, 272.0 KB. The product, pouch label and carton label are all correct and the correct DFU is in the package. It was launched in the United States in May of 2012. If needed, perform capture and sense and lead impedance tests. The Express Coronary Stent System was granted approval by Boston Scientific's notified body (TUV Rheinland) to permit CE marking June 18, 2001. The FDA has identified this as a Class I recall, the most serious type of recall. Epic is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual for additional details about patient monitoring. 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. 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. If the stent migrates to the heart, it could cause life-threatening injury. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. PDF Platinum Chromium Coronary Stent System REBEL - Food and Drug The Epic Stent should not migrate in this MRI environment. MRI is an effective method of providing detailed diagnosis for many types of injuries and conditions, including cardiovascular disease. Premarket Approval (PMA) 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. MRI Safety Home Refer to the . 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. 300 Boston Scientific Way . Note: If you need help accessing information in different file formats, see C-codesare used for hospital outpatient device reporting for Medicare and some private payers. For more information, please visit: www.bostonscientific.com. GMDN Names and Definitions: Copyright GMDN Agency 2015. 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. "The Epic Stent has been very well-received by physicians across the country. The default MRI parameter settings are automatically stored in the Abbott MR Conditional device. 38948-8607. 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 The Epic Stent is compatible with 6F sheaths, and the stent delivery system is compatible with 0.035 inch guidewires. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. THE List - MRI Safety Patients receiving coronary stents have typically been required to wait approximately two months before receiving an MRI. The stent is constrained within a 6F delivery system. 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. IFbj.)D^7TE.V\Bz->/. MRI safety testing has shown that the REBEL Stent is MR Conditional and that The C-code used for this product is C1876, Stent, non-coated/non-covered with delivery system. The Sentinol Nitinol Stent System is comprised of two components: the implantable . [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. 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. 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. Device Size Text, specify: 75 cm Effective Length, Device Size Text, specify: 40 mm Stent Length, Device Size Text, specify: 10 mm Stent Diameter. You can search by product, model number, category or family. 1.5,3: The MAE rate at 12 months was 5.4 percent, with all MAEs related to TVR. {}(;]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? 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.