As the stent is exposed to body temperature it expands to appose the duct wall. Catalog No. Based on the country you select, you can choose the device and lead combination (if applicable) to get scan parameters. Precautions
As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements.
The Boston Scientific Epic Stent Continues to Demonstrate Positive MRI safety testing has shown that the REBEL Stent is MR Conditional and that Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review a list of adverse conditions and effects. 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: The Sentinol Nitinol Stent System is comprised of two components: the implantable endoprosthesis and the stent delivery system. The stent is constrained within a 6F delivery system. "Following the recent presentation of our nine-month data, the 12-month ORION data continue to show very strong clinical outcomes," said Dr. Clair. The Epic Nitinol Stent System received CE Mark approval and was launched in Europe and other international markets in 2009. It was launched in the United States in May of 2012. CAUTION: These products are intended for use by or under the direction of a physician. 1.5,3: Conditional 5 More . Made in USA 5905 Nathan Lane, Plymouth, MN 55442, USA. The ORION clinical data was used to support application for U.S. Food and Drug Administration approval of the Epic Stent System. 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. 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. 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. 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. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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. Proper patient monitoring must be provided during the MRI scan. Indications for Use The Wallstent Venous Endoprosthesis is indicated for improving central venous diameter . [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. 7th.Ine!Y+mOTqDm/`*XBagB8GzXov8P1zluIz y "0!rab/dMwLtX1@_18TUWW\ T/~dc/mRE The FDA has identified this as a Class I recall, the most serious type of recall. %PDF-1.4
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The Express Coronary Stent System was granted approval by Boston Scientific's notified body (TUV Rheinland) to permit CE marking June 18, 2001. 86 0 obj
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"The Epic Stent has been very well-received by physicians across the country.
PDF Summary of Safety and Effectiveness Data WALLSTENT with Unistep The MRI parameter settings are selected at the physician's discretion. 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. Boston Scientific 2 Agenda I. The prospective, single-arm ORION trial enrolled 125 patients at 28 sites in the United States. Follow the checklist instructions within Merlin PCS Programmer. The MAE rate at 12 months was 5.4 percent, with all MAEs related to TVR. 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. "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. Note: Boston Scientific is not responsible for the correct use of codes on submitted claims; this informationdoes not constitute reimbursement or legal advice. All other trademarks are the property of their respective owners. Disposable devices associated with implantation may be included.
PDF Summary of Safety and Effectivness (SSED)Template
A tracking/verification form is asked to be returned to Boston Scientific and arrangements will be made for retuning the affected product.
Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review a list of adverse conditions and effects.
Epic Vascular Self-Expanding Stent System - Boston Scientific AccessGUDID - Ascerta Firm (08714729861720)- Ureteral Stent. You can search by model number or product category.
News Releases - Boston Scientific It may be a continuous tube or a mesh structure in tubular form and is available in a variety of lengths and diameters. 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. 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. 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. 3: Conditional 6 .
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. Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. "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.". 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. MR imaging provides excellent spatial . All rights reserved. 1.5 . An official website of the United States government, : hbbd``b` C9E tk`/@PHA,HyM! Physicians interested in reviewing a complete copy of the revised TAXUS Express2 stent DFU may obtain a copy from the TAXUS website at www.taxus-stent.com. The C-code used for this product is C1876, Stent, non-coated/non-covered with delivery system. GMDN Names and Definitions: Copyright GMDN Agency 2015. "The Epic Stent is a novel stent platform designed to offer both acute and clinical advantages over older-generation stent systems. Orthopedic Implants, Materials, and Devices More. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and may be inserted with a balloon catheter which causes . The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. The site is secure. 1 0 obj
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Unless otherwise specified, all product names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. Safety Topic / Subject Enterra II Model 37800 Gastric Electrical Stimulation (GES) System . Instructions for Downloading Viewers and Players.
Patients experienced significant clinical improvement from baseline to twelve months based on feedback from validated questionnaires evaluating walking distance, speed and stair climbing. 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. Fortunately, the devices that exhibited po, 2D Helical, 35 Fibered Platinum Coil. The delivery system is compatible with 0.035 in.
Drummond wire (316L SS) orthopedic implant. 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. 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. No deaths have been reported. (0.89mm) guidewires. Instructions for Downloading Viewers and Players, Class 3 Device Recall Sentinol Nitinol Biliary Stent System. A Recall Notice, dated 05/14/04, was sent to appropriate hospital personnel. Coils, Filters, Stents, and Grafts More. Coronary data supports safety of paclitaxel and ELUVIA DES IV. Once you have completed the checklist, select the Program MRI Settings button to enable MRI Settings. Sterile. These devices are considered MR Unsafe.
MRI Safety for Cardiovascular Products I Abbott Safe More. 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. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual for details on default settings and how to save modified settings for scanning. 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. 2022 Boston Scientific Corporation or its affiliates. Use this database for arrhythmia, heart failure and structural heart products. The Notice described the issue, identified affected product and asked that the use of affected product be discontinued and affected units be segregated. The Merlin PCS Programmer will print to the default printer (internal printer, external printer or PDF). Interrogate the device with the Merlin PCS Programmer and Aveir Link Module. The .gov means its official.Federal government websites often end in .gov or .mil. 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. 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. Based on the country you select, you can choose the device and lead combination (if applicable) to get scan parameters. An inner shaft, with two radiopaque markers, aids in the placement of the stent.
THE List - MRI Safety Learn the steps for safely preparing Abbotts MRI-Ready GallantTM and EntrantTM High Voltage ICD and CRT-D devices for an MRI scan.
AccessGUDID - DEVICE: Tria Soft (08714729959915) Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. This site uses cookies. 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. 1.5,3: "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. Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . 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. Furthermore, outcomes for very complex (TASC C/D) lesions were similar to those reported for less complex (TASC A/B) lesions. Indicates a trademark of the Abbott group of companies. 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 Epic Stent Demonstrates Positive Clinical Outcomes The default MRI parameter settings are automatically stored in the Abbott MR Conditional device. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 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. We recommend that you download and review the most current version any time a patient with an Abbott product needs an MRI. Illustrations are artist's representations only and should not be considered as engineering drawings or photographs. For more information, please visit: www.bostonscientific.com. MRI at 3T or 1.5T may be performed immediately following the implantation of the Epic Stent. Coils, Filters, Stents, and Grafts More. 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. 121 0 obj
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Before sharing sensitive information, make sure you're on a federal government site. H7YPnf'Sq-. 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 Express 2 Monorail and Over-the-Wire Coronary Stent Systems have not yet been marketed in any country. 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/.