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. 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). Alternatively, you can also use the latest MRI Manuals to determine scan parameters. With our stent systems, MRI analyses can now be performed immediately.". MRI at 3T or 1.5T may be performed immediately following the implantation of the Epic Stent. We recommend that you download and review the most current version any time a patient with an Abbott product needs an MRI. MRI safety testing has shown that the REBEL Stent is MR Conditional and that Are you a healthcare professional? This site uses cookies. 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. 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. Boston Scientific Corporation . The Sentinol Nitinol Stent System is comprised of two components: the implantable .
THE List - MRI Safety As the stent is exposed to body temperature it expands to appose the duct wall. 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. Platinum Chromium Coronary Stent System (Monorail) Device Procode: Applicant's Name and Address: NIQ . Please be sure to read it. Illustrations are artist's representations only and should not be considered as engineering drawings or photographs. Our manuals contain the latest instructions and information for cardiac physicians, radiologists and MR technologists. Magnetic Resonance Imaging (MRI) Safety for Boston Scientific Peripheral Products PDF, 272.0 KB. The site is secure. The information provided here is not intended to provide information to patients and the general public. 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 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. {}(;]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
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V}-St:Ur{>J;{n=b^mZ? Unless otherwise specified, all product names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review a list of adverse conditions and effects. Introduction II.
No deaths have been reported. Furthermore, outcomes for very complex (TASC C/D) lesions were similar to those reported for less complex (TASC A/B) lesions. The Express Coronary Stent System was granted approval by Boston Scientific's notified body (TUV Rheinland) to permit CE marking June 18, 2001. Conditional 6 More. Indicates a third party trademark, which is property of its respective owner.
Can I undergo MRI or scanner testing with a stent? Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 1.5,3: Conditional 5 More . 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 TAXUS stent system is the first drug-eluting stent to receive approval for immediate post-procedure MRI. 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. Coronary data supports safety of paclitaxel and ELUVIA DES IV. [N-'u,uDQOUyUInFl
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Metal Expandable Biliary Stents - Food and Drug Administration Search for coronary and peripheral disease and valve disease IFUS. 0
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Use of these devices may cause serious injuries or death. Find products, medical specialty information, and education opportunities. Learn the steps for safely preparing Abbotts MRI-Ready GallantTM and EntrantTM High Voltage ICD and CRT-D devices for an MRI scan.
If a device is not shown in the list, it is not MR Conditional. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. You can search by product, model number, category or family. The Epic Stent should not migrate in this MRI environment. Several of these demonstrated magnetic field interactions. Abbotts MRI-Ready High Voltage Device Setup for Gallant and Entrant ICD and CRT-Ds (11:45). Refer to the manuals for CardioMEMS HF System or MR Conditional ICMs for details about MRIs with those devices. 5-year data for. 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. Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537 1.888.272.1001 www.BostonScientific.com . Read our privacy policy to learn more. MRI is an effective method of providing detailed diagnosis for many types of injuries and conditions, including cardiovascular disease. 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. GMDN Names and Definitions: Copyright GMDN Agency 2015. 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. "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. This press release contains forward-looking statements. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. 2023 Boston Scientific Corporation or its affiliates. Coils, Filters, Stents, and Grafts More. HWnFC=ji6n
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9x?pFH=@q}+[|Gd $Xp7lXcV5ZID?vM1V]kM).? 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: Interrogate the device with the Merlin PCS Programmer and Aveir Link Module.
PDF Platinum Chromium Coronary Stent System REBEL - Food and Drug Data from the first human use NG PROMUS Clinical Trial evaluating the safety and effectiveness of the Promus PREMIER Everolimus-Eluting . The FDA has identified this as a Class I recall, the most serious type of recall. Stent delivery system (SDS): A system that delivers a biliary stent to a target site within the bile duct and then deploys the stent. 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. 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. 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. All rights reserved.
Safety of Magnetic Resonance Imaging in Patients With - Circulation 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
MRI Safety for Cardiovascular Products I Abbott AccessGUDID - DEVICE: Epic Vascular (08714729805014) Orthopedic Implants, Materials, and Devices More. The MAE rate at 12 months was 5.4 percent, with all MAEs related to TVR.
Boston Scientific Corporation Recalls VICI VENOUS STENT System and VICI 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 a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file hereafter. This stent has not been evaluated to determine if it is MR Conditional beyond these conditions.
THE List - MRI Safety Made in USA 5905 Nathan Lane, Plymouth, MN 55442, USA. 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." Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 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. This cautionary statement is applicable to all forward-looking statements contained in this document. 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. Within US to KY, MA, NC, NH, NJ, PA, TX, VA, WA.
Boston Scientific Promus PREMIER And SYNERGY Drug-Eluting Stent Boston Scientific Sentinol Self-Expanding Nitinol Biliary Stent System with Over-the-Wire Delivery System. %%EOF
(0.89mm) guidewires. Overview of the ELUVIA Drug- Eluting Stent (DES) III.
Class 3 Device Recall Sentinol Nitinol Biliary Stent System 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. This scientific statement is intended to summarize and clarify issues regarding the safety of MR imaging in patients with cardiovascular devices. 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. Search for arrhythmia, heart failure and structural heart IFUs. "The Epic Stent is a novel stent platform designed to offer both acute and clinical advantages over older-generation stent systems. MR imaging provides excellent spatial . 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. "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.
Premarket Approval (PMA) "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. The Express 2 Monorail and Over-the-Wire Coronary Stent Systems have not yet been marketed in any country.
PDF Table of Contents - WATCHMAN Marlborough, MA 01752-1566 . There have been 17 complaints and reported injuries related to this issue. 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. ,TFZ3R?ZU,6P;0rY;qC\#*"zgZ71j:clLv^O LHf,xvU8pZ7 9^FHZ|+iL V~G!=}6. Sterile. 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.
PDF 2 7 2 Epic Vascular 2 - Boston Scientific
2022 Boston Scientific Corporation or its affiliates. This includes continuous monitoring of the patient's hemodynamic function. 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. It may be a continuous tube or a mesh structure in tubular form and is available in a variety of lengths and diameters.
"The FDA approval of the timing on MRI exams is a significant development for interventional cardiologists and their patients," said Paul LaViolette, Boston Scientific Chief Operating Officer. 7th.Ine!Y+mOTqDm/`*XBagB8GzXov8P1zluIz y "0!rab/dMwLtX1@_18TUWW\ T/~dc/mRE 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. Catalog No.
PDF Summary of Safety and Effectiveness The Notice described the issue, identified affected product and asked that the use of affected product be discontinued and affected units be segregated. The C-code used for this product is C1876, Stent, non-coated/non-covered with delivery system. Dry Pad 9 x 9 with Silver Antimicrobial Agent. For more information, please visit: www.bostonscientific.com. All other trademarks are the property of their respective owners. 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. A stent delivery system for a balloon expandable stent consists 86 0 obj
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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. Safety Topic / Subject Enterra II Model 37800 Gastric Electrical Stimulation (GES) System . The revised Express2 bare-metal stent DFU will be available shortly. The positive data support the Boston Scientific goal of delivering products designed to reduce the need for reinterventions and help lower overall healthcare costs.
Boston Scientific's ELUVIA Drug-Eluting Stent and Coronary Paclitaxel 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. 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. 121 0 obj
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Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review a list of adverse conditions and effects. The stent is constrained within a 6F delivery system. Use this database for coronary intervention, peripheral intervention and valve repair products. Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words. C-codesare used for hospital outpatient device reporting for Medicare and some private payers. Epic is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. 1.5,3: No amputations were reported through the 12-month period. 510(K)s with Product Code = FGE and Original Applicant = BOSTON SCIENTIFIC CORP. Patients receiving coronary stents have typically been required to wait approximately two months before receiving an MRI. Fortunately, the devices that exhibited po, 2D Helical, 35 Fibered Platinum Coil. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting, 12-month Primary Patency by TASC Classification, See all healthcare professional information, 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, Epic Vascular Self-Expanding Stent System, EDUCARE Medical Education and Training Courses, ADVANTICS Innovative Healthcare Solutions, Do not sell or share my personal information, 0 amputations at 3 years (106 subjects), ORION US IDE Clinical Trial to demonstrate similar patency across all TASC classifications, Tandem Architecture Stent Design features Macro, Medium and Micro Struts, as well as patented connector patternsdesigned to optimize flexibility, Hybrid Architecture Design with open- and closed-cell geometry engineered to provide flexibility and deployment uniformity, Macro and Micro Struts are engineered to work in tandem for balanced forceeven in tortuous vasculature, Ergonomic handle with two convenient deployment options: thumb wheel and pull grip, Radiopaque stent markers and catheter shaft marker band enhance visibility and simplify placement, Meticulous surface finishing and polishing to remove imperfections and improve fracture resistance, Tandem Architecture Stent Design engineered to bend and flex and reduce the risk of fracture, 0% Amputation of index limb at 12-months (0/111).