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." Introduction II. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 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. A stent delivery system for a balloon expandable stent consists :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\. 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. %PDF-1.4 % Class 3 Device Recall Sentinol Nitinol Biliary Stent System. Sterile. It may be a continuous tube or a mesh structure in tubular form and is available in a variety of lengths and diameters. THE List - MRI Safety Search for coronary and peripheral disease and valve disease IFUS. Boston Scientific 2 Agenda I. The Express 2 Monorail and Over-the-Wire Coronary Stent Systems have not yet been marketed in any country. Boston Scientific Promus PREMIER And SYNERGY Drug-Eluting Stent ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. Be sure to check the lead combination(s) (if applicable) to ensure you select the correct settings. Fortunately, the devices that exhibited po, 2D Helical, 35 Fibered Platinum Coil. 5-year data for. This press release contains forward-looking statements. %%EOF 38948-8607. Paul, M, Esophageal Reconstruction TubeHood Laboratories, www.hoodlabs.com, Esophageal Stent, Niti-S & Comvi Model E2423TaeWoong Medical Co., Ltd., www.stent.net, Esophageal StentHood Laboratories, www.hoodlabs.com, Esophageal TTS StentTaeWoong Medical Co., Ltd., www.stent.net, Esophagus Full-Covered StentCG BIO CO., LTD. www.cgbio.co.kr/en/. Device Size Text, specify: 75 cm Effective Length, Device Size Text, specify: 40 mm Stent Length, Device Size Text, specify: 10 mm Stent Diameter. Safety of Magnetic Resonance Imaging in Patients With - Circulation Boston Scientific Corporation Recalls VICI VENOUS STENT System and VICI By using this site, you consent to the placement of our cookies. Class 3 Device Recall Sentinol Nitinol Biliary Stent System The delivery system is compatible with 0.035 in. Before sharing sensitive information, make sure you're on a federal government site. Catalog No. Precautions (,OcEh{[%E#Xl@::9(k]xv# q#fs+[Jb{-$r;EB9 pdRkEdq^(PFG3|'ae1wsv4N5:YBswO[kQC9U0EJ[Tkd/*4s3_SN}W~jj,SPuT-9 )44ZtGtWAO@Fo aP3lqS-P*)v"rj5QEWL!zg8KbORyvm?B'tZ&3D#>7"7Q8&a*$"xmVTeV [@[@.o)BpiyHpV1FIh\w|wD!2N^# U#gb a]qkz,'@Ri3 If the stent migrates to the heart, it could cause life-threatening injury. 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. Use of these devices may cause serious injuries or death. PDF Summary of Safety and Effectivness (SSED)Template 121 0 obj <>stream BSC began marketing the product internationally following approval in September 2001. 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. A tracking/verification form is asked to be returned to Boston Scientific and arrangements will be made for retuning the affected product. 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. With our stent systems, MRI analyses can now be performed immediately.". Boston Scientific's Express 2 (bare-metal) stent system also received approval for immediate MRI exams. 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. 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. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 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. 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. Marlborough, MA 01752-1566 . 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. The stent is constrained within a 6F delivery system. PDF Table of Contents - WATCHMAN THE List - MRI Safety "Following the recent presentation of our nine-month data, the 12-month ORION data continue to show very strong clinical outcomes," said Dr. Clair. No deaths have been reported. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Search for arrhythmia, heart failure and structural heart IFUs. Overview of the ELUVIA Drug- Eluting Stent (DES) III. Boston Scientific performed rigorous laboratory testing to demonstrate MRI compatibility. 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. 38948-8607. All other trademarks are the property of their respective owners. PDF Summary of Safety and Effectiveness Data WALLSTENT with Unistep 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. {}(;]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? May be removed prior to MRI and replaced after the MRI exam. Esophageal Stent, Niti-S & Comvi Model E2423 TaeWoong Medical Co., Ltd., www.stent.net. The C-code used for this product is C1876, Stent, non-coated/non-covered with delivery system. Read our privacy policy to learn more. Patients experienced significant clinical improvement from baseline to twelve months based on feedback from validated questionnaires evaluating walking distance, speed and stair climbing. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and may be inserted with a balloon catheter which causes . Refer to the . All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. THE List - MRI Safety endstream endobj 60 0 obj <>>>/Filter/Standard/Length 128/O(v~aIgInj rM)/P -1340/R 4/StmF/StdCF/StrF/StdCF/U( ey,62_ )/V 4>> endobj 61 0 obj <>>> endobj 62 0 obj <> endobj 63 0 obj <>/ExtGState<>/Font<>/ProcSet[/PDF/Text]/Properties<>/Shading<>/XObject<>>>/Rotate 0/TrimBox[24.0 24.0 619.276 865.89]/Type/Page>> endobj 64 0 obj <>stream AccessGUDID - DEVICE: Ascerta (08714729802976) Within US to KY, MA, NC, NH, NJ, PA, TX, VA, WA. Made in USA 5905 Nathan Lane, Plymouth, MN 55442, USA. AccessGUDID - DEVICE: Ascerta Firm (08714729861720) The information provided here is not intended to provide information to patients and the general public. 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. Can I undergo MRI or scanner testing with a stent? The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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 Please be sure to read it. When ready to be implanted, the stent is deployed by retracting the exterior shaft of the delivery system. Boston Scientific Corporation . %PDF-1.5 % 1.5,3: The default MRI parameter settings are automatically stored in the Abbott MR Conditional device. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. You can search by model number or product category. These devices are considered MR Unsafe. The product, pouch label and carton label are all correct and the correct DFU is in the package. 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 For more information, please visit: www.bostonscientific.com. Epic Vascular Self-Expanding Stent System - Boston Scientific @Bd!$7@"rAOgx 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. Use this database for arrhythmia, heart failure and structural heart products. The delivery system is of coaxial design with an exterior shaft to protect and constrain the stent prior to deployment. 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. The Boston Scientific Epic Stent Continues to Demonstrate Positive 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. 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). Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . Orthopedic Implants, Materials, and Devices More. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review how data will be handled by each system. Fortunately, the devices that exhibited po . Date of Panel Recommendation: None Premarket Approval Application (PMA) Number: P150003/S058 Date of FDA Notice of Approval: August 10, 2020 MRI Safety Home 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 prospective, single-arm ORION trial enrolled 125 patients at 28 sites in the United States. This cautionary statement is applicable to all forward-looking statements contained in this document. These devices are considered MR Unsafe. Epic is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. Based on the country you select, you can choose the device and lead combination (if applicable) to get scan parameters. The Express Coronary Stent System was granted approval by Boston Scientific's notified body (TUV Rheinland) to permit CE marking June 18, 2001. Coils, stents, filters and vascular grafts have been evaluated relative to the use of MR systems. MR imaging provides excellent spatial . We recommend that you download and review the most current version any time a patient with an Abbott product needs an MRI. Furthermore, outcomes for very complex (TASC C/D) lesions were similar to those reported for less complex (TASC A/B) lesions. No amputations were reported through the 12-month period. The Epic Stent should not migrate in this MRI environment. 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.". 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 [?] 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. 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. 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. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. This site uses cookies. "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. 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. Metal Expandable Biliary Stents - Food and Drug Administration The MAE rate at 12 months was 5.4 percent, with all MAEs related to TVR. Disposable devices associated with implantation may be included. Dry Pad 9 x 9 with Silver Antimicrobial Agent. MRI safety testing has shown that the REBEL Stent is MR Conditional and that "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. MRI Safety for Cardiovascular Products I Abbott From the FastPath Summary screen, select the Print button to print the Diagnostics and any other relevant reports. ,TFZ3R?ZU,6P;0rY;qC\#*"zgZ71j:clLv^O LHf,xvU8pZ7 9^FHZ|+iL V~G!=}6. Instructions for Downloading Viewers and Players. 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 2022 Boston Scientific Corporation or its affiliates. endstream endobj startxref 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. 1.5,3: Conditional 5 More . If needed, perform capture and sense and lead impedance tests. 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 Sentinol Nitinol Stent System is comprised of two components: the implantable . of Abbott Medical Japan GK. 7th.Ine!Y+mOTqDm/`*XBagB8GzXov8P1zluIz y "0!rab/dMwLtX1@_18TUWW\ T/~dc/mRE Learn the steps for safely preparing Abbotts MRI-Ready GallantTM and EntrantTM High Voltage ICD and CRT-D devices for an MRI scan. 2*Uax?t} 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. 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. The positive data support the Boston Scientific goal of delivering products designed to reduce the need for reinterventions and help lower overall healthcare costs. MRI at 3T or 1.5T may be performed immediately following the implantation of the Epic Stent. Premarket Approval (PMA) The ORION clinical data was used to support application for U.S. Food and Drug Administration approval of the Epic Stent System. AccessGUDID - Ascerta Firm (08714729861720)- Ureteral Stent. IFbj.)D^7TE.V\Bz->/. "The Epic Stent has been very well-received by physicians across the country. Use this database for coronary intervention, peripheral intervention and valve repair products. The .gov means its official.Federal government websites often end in .gov or .mil. 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 Based on the country you select, you can choose the device and lead combination (if applicable) to get scan parameters. Alternatively, you can also use the latest MRI Manuals to determine scan parameters. Advances in magnetic resonance (MR) imaging and MR angiography over the last 2 decades have led to MR becoming an increasingly attractive imaging modality. f@ 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.
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