Boston Scientific's ELUVIA Drug-Eluting Stent and Coronary Paclitaxel No amputations were reported through the 12-month period. ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. 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). 1.5 . PDF Summary of Safety and Effectiveness Data (Ssed) News Releases - Boston Scientific "Following the recent presentation of our nine-month data, the 12-month ORION data continue to show very strong clinical outcomes," said Dr. Clair. 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. Follow the checklist instructions within Merlin PCS Programmer. H7YPnf'Sq-. Are you a healthcare professional? 2023 Boston Scientific Corporation or its affiliates. The revised Express2 bare-metal stent DFU will be available shortly. 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. The stent is constrained within a 6F delivery system. 38948-8607. 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. 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. Coils, Filters, Stents, and Grafts More. A tracking/verification form is asked to be returned to Boston Scientific and arrangements will be made for retuning the affected product. 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. "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.". When ready to be implanted, the stent is deployed by retracting the exterior shaft of the delivery system. Conditional 6 More. 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. 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. 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. This site is Exclusively Sponsored by BRACCO. 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. Alternatively, you can also use the latest MRI Manuals to determine scan parameters. AccessGUDID - Ascerta Firm (08714729861720)- Ureteral Stent. IFbj.)D^7TE.V\Bz->/. 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. 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 a device is not shown in the list, it is not MR Conditional. 3: Conditional 6 . 5-year data for. 300 Boston Scientific Way . The prospective, single-arm ORION trial enrolled 125 patients at 28 sites in the United States. Sterile. One lot of one catalog number of the Sentinol Nitinol Biliary Stent System may have been packaged in a Sentinol nitinol Vascular outer carton. Stent delivery system (SDS): A system that delivers a biliary stent to a target site within the bile duct and then deploys the stent. C-codesare used for hospital outpatient device reporting for Medicare and some private payers. Coils, stents, filters and vascular grafts have been evaluated relative to the use of MR systems. Instructions for Downloading Viewers and Players. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. All rights reserved. Class 3 Device Recall Sentinol Nitinol Biliary Stent System Reproduced with Permission from the GMDN Agency. MR imaging provides excellent spatial . 0.3. The ORION clinical data was used to support application for U.S. Food and Drug Administration approval of the Epic Stent System. Proper patient monitoring must be provided during the MRI scan. 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 Once you have completed the checklist, select the Program MRI Settings button to enable MRI Settings. The .gov means its official.Federal government websites often end in .gov or .mil. PDF Platinum Chromium Coronary Stent System REBEL - Food and Drug A Recall Notice, dated 05/14/04, was sent to appropriate hospital personnel. Platinum Chromium Coronary Stent System (Monorail) Device Procode: Applicant's Name and Address: NIQ . This cautionary statement is applicable to all forward-looking statements contained in this document. 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. %PDF-1.5 % Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Furthermore, outcomes for very complex (TASC C/D) lesions were similar to those reported for less complex (TASC A/B) lesions. MRI Safety Home The C-code used for this product is C1876, Stent, non-coated/non-covered with delivery system. Precautions Abbotts MRI-Ready High Voltage Device Setup for Gallant and Entrant ICD and CRT-Ds (11:45). THE List - MRI Safety {}(;]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? 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). All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. MRI is an effective method of providing detailed diagnosis for many types of injuries and conditions, including cardiovascular disease. 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. Boston Scientific Promus PREMIER And SYNERGY Drug-Eluting Stent This press release contains forward-looking statements. The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. "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. 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. AccessGUDID - DEVICE: Ascerta Firm (08714729861720) 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. Interrogate the device with the Merlin PCS Programmer and Aveir Link Module. Drummond wire (316L SS) orthopedic implant. f@ Safety Topic / Subject Enterra II Model 37800 Gastric Electrical Stimulation (GES) System . of Abbott Medical Japan GK. If the stent migrates to the heart, it could cause life-threatening injury. 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. AccessGUDID - DEVICE: Tria Soft (08714729959915) It is required to program the device to MRI Settings as part of the MRI scan workflow. 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 %PDF-1.4 % Unless otherwise specified, all product names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. Dry Pad 9 x 9 with Silver Antimicrobial Agent. Note: If you need help accessing information in different file formats, see Can I undergo MRI or scanner testing with a stent? Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words. Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . (,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 needed, perform capture and sense and lead impedance tests. 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. Instructions for Downloading Viewers and Players, Class 3 Device Recall Sentinol Nitinol Biliary Stent System. 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 for additional details about patient monitoring. The delivery system is compatible with 0.035 in. It may be a continuous tube or a mesh structure in tubular form and is available in a variety of lengths and diameters. Indicates a trademark of the Abbott group of companies. 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: 510(K)s with Product Code = FGE and Original Applicant = BOSTON SCIENTIFIC CORP. 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. Safety of Magnetic Resonance Imaging in Patients With - Circulation PDF 2 7 2 Epic Vascular 2 - Boston Scientific A stent delivery system for a balloon expandable stent consists Premarket Approval (PMA) Indications for Use The Wallstent Venous Endoprosthesis is indicated for improving central venous diameter . [N-'u,uDQOUyUInFl yO/'wjGs1lx"O88KT9/vjTn ]Y~k\}C ? For more information, please visit: www.bostonscientific.com. THE List - MRI Safety Boston Scientific's Express 2 (bare-metal) stent system also received approval for immediate MRI exams. Before sharing sensitive information, make sure you're on a federal government site. AccessGUDID - DEVICE: Ascerta (08714729802976) 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. 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. AccessGUDID - DEVICE: Ascerta Firm (08714729861775) Language Assistance Available: Espaol | | Ting Vit | | Tagalog | | | Kreyl Ayisyen | Franais | Polski | Portugus | Italiano | Deutsch | | | English, Stents, Drains And Dilators For The Biliary Ducts, Code of Federal Regulations (CFR) Title 21 7.55. Patients receiving coronary stents have typically been required to wait approximately two months before receiving an MRI. This site is Exclusively Sponsored by BRACCO, ENTERRA THERAPY, Gastric Electrical Stimulation (GES), Neurostimulation System, Orthopedic Implants, Materials, and Devices, Cerebrospinal Fluid (CSF) Shunt Valves and Accessories, Hemostatic Clips, Other Clips, Fasteners, and Staples.