boston scientific epic stent mri safety

All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. Epic Stent Boston Scientific, www.bostonscientific.com. Catalog No. Search for arrhythmia, heart failure and structural heart IFUs. ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. 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. 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. Orthopedic Implants, Materials, and Devices More. Find products, medical specialty information, and education opportunities. The delivery system is of coaxial design with an exterior shaft to protect and constrain the stent prior to deployment. Abbotts MRI-Ready High Voltage Device Setup for Gallant and Entrant ICD and CRT-Ds (11:45). It was launched in the United States in May of 2012. There have been 17 complaints and reported injuries related to this issue. Drummond wire (316L SS) orthopedic implant. The Sentinol Nitinol Stent System is comprised of two components: the implantable endoprosthesis and the stent delivery system. Marlborough, MA 01752-1566 . 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. A tracking/verification form is asked to be returned to Boston Scientific and arrangements will be made for retuning the affected product. Boston Scientific, www.bostonscientific.com, Neuroform Atlas Stent Non-clinical testing and analysis have demonstrated that the Neuroform Atlas Stent is MR Conditional alone, or when overlapped with a second stent, and adjacent to a Stryker Neur, AAA Endograft Ovation Ovation Abdominal Stent Graft System TriVascular2, Inc. Santa Rosa, CA, Abre StentMedtronic, Inc., www.Medtronic.com/MRI, Absolute .035 Biliary Self-Expanding StentAbbott Vascular, www.abbottvascular.com, ABSOLUTE 0.35 Biliary Self Expanding Stent System Guidant http://www.guidant.com/ifu/, Absolute Biliary StentAbbott Vascularwww.abbottvascular.com, Absolute Pro .035 Biliary Self-Expanding StentAbbott Vascular, www.abbottvascular.com, Absolute Pro Peripheral Stent Abbott Vascular www.Abbott.com, Absolute Pro Stent Nickel titanium with nickel titanium platinum markers 8-mm x 120-mm Single version Abbott Vascular Santa Clara, CA, Absolute Pro Stent Nickel titanium with nickel titanium platinum markers 8-mm x 348-mm three overlapped version Abbott Vascular Santa Clara, CA, ABSOLUTE Biliary Self-Expanding Stent System Nitinol coils, filters, stents Guidant Endovascular Solutions Santa Clara, CA, Absorb Bioresorbable Vascular Scaffold (BVS) SystemAbbott Vascular, www.abbottvascular.com, Absorb GT1 Bioresorbable Vascular Scaffold (BVS) SystemAbbott Vascular,www.abbottvascular.com, Acculink Carotid StentAbbott Vascularwww.abbottvascular.com, ACCULINK Carotid StentGuidanthttp://www.guidant.com/ifu/, ACS MULTI-LINK Coronary StentAbbott Vascularwww.abbottvascular.com, ACS MULTI-LINK DUET Coronary StentAbbott Vascularwww.abbottvascular.com. The Epic Stent is compatible with 6F sheaths, and the stent delivery system is compatible with 0.035 inch guidewires. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 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). 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. of Abbott Medical Japan GK. %PDF-1.4 % The Merlin PCS Programmer will print to the default printer (internal printer, external printer or PDF). This stent has not been evaluated to determine if it is MR Conditional beyond these conditions. Made in USA 5905 Nathan Lane, Plymouth, MN 55442, USA. Based on the country you select, you can choose the device and lead combination (if applicable) to get scan parameters. Precautions 38948-8607. 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. f@ 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. 38948-8607. MRI safety testing has shown that the REBEL Stent is MR Conditional and that 2022 Boston Scientific Corporation or its affiliates. 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. Boston Scientific, www.bostonscientific.com . {}(;]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? Search for coronary and peripheral disease and valve disease IFUS. IFbj.)D^7TE.V\Bz->/. You can search by product, model number, category or family. 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. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Sterile. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Several of these demonstrated magnetic field interactions. Date of Panel Recommendation: None Premarket Approval Application (PMA) Number: P150003/S058 Date of FDA Notice of Approval: August 10, 2020 Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Disposable devices associated with implantation may be included. 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/. Before sharing sensitive information, make sure you're on a federal government site. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. The FDA has identified this as a Class I recall, the most serious type of recall. C-codesare used for hospital outpatient device reporting for Medicare and some private payers. 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. Patients experienced significant clinical improvement from baseline to twelve months based on feedback from validated questionnaires evaluating walking distance, speed and stair climbing. (,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 An inner shaft, with two radiopaque markers, aids in the placement of the stent. "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. Dry Pad 9 x 9 with Silver Antimicrobial Agent. These devices are considered MR Unsafe. 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. 1) Confirm MRI readiness. The ORION clinical data was used to support application for U.S. Food and Drug Administration approval of the Epic Stent System. The revised Express2 bare-metal stent DFU will be available shortly. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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. Sterile. If the stent migrates to the heart, it could cause life-threatening injury. The Express 2 Monorail and Over-the-Wire Coronary Stent Systems have not yet been marketed in any country. Data from the first human use NG PROMUS Clinical Trial evaluating the safety and effectiveness of the Promus PREMIER Everolimus-Eluting . 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. 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. Be sure to check the lead combination(s) (if applicable) to ensure you select the correct settings. The Express Coronary Stent System was granted approval by Boston Scientific's notified body (TUV Rheinland) to permit CE marking June 18, 2001. Boston Scientific 2 Agenda I. HWnFC=ji6n 9/~\:\$$rxnsU,)Ielo((a,$4bY?W7)MoQEHk1s-;]zXJ$G=0.F4VJYwS|U9VOU@n0ZL26w~+y38.$qW|%-zu'2g:,IwA28nvnP R%ivTpks5>/m5p)H,!HIsqz 9x?pFH=@q}+[|Gd $Xp7lXcV5ZID?vM1V]kM).? 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. Illustrations are artist's representations only and should not be considered as engineering drawings or photographs. Coronary data supports safety of paclitaxel and ELUVIA DES IV. Class 3 Device Recall Sentinol Nitinol Biliary Stent System. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and may be inserted with a balloon catheter which causes . The stent is a laser cut self-expanding stent composed of a nickel titanium alloy(nitinol). Results were presented today by Daniel Clair, M.D., FACS, principal investigator of the . CAUTION: These products are intended for use by or under the direction of a physician. Coils, stents, filters and vascular grafts have been evaluated relative to the use of MR systems. Cautionary Statement Regarding Forward-Looking Statements. 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. "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.". If a device is not shown in the list, it is not MR Conditional. Instructions for Downloading Viewers and Players, Class 3 Device Recall Sentinol Nitinol Biliary Stent System. All other trademarks are the property of their respective owners. Interrogate the device with the Merlin PCS Programmer and Aveir Link Module. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review a list of adverse conditions and effects. For more information, please visit: www.bostonscientific.com. DVAz~U|OH_P&xuN)Z6:U<0GI+LQj%]mr2&4SCjyWlQq0H[-2vmu5*Q]zp`MocdS.I>^fp~DEBdo(t This press release contains forward-looking statements. Boston Scientific's Express 2 (bare-metal) stent system also received approval for immediate MRI exams. A stent delivery system for a balloon expandable stent consists Coils, Filters, Stents, and Grafts More. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements. All rights reserved. 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. This scientific statement is intended to summarize and clarify issues regarding the safety of MR imaging in patients with cardiovascular devices. Note: If you need help accessing information in different file formats, see 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. It may be a continuous tube or a mesh structure in tubular form and is available in a variety of lengths and diameters. Boston Scientific Corporation . 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 If you are not using the MRI Activator, MRI Settings must be disabled by the patient's device management physician or clinician using the Merlin PCS Programmer and Aveir Link Module (if applicable). 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. 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.