AccessGUDID - DEVICE: Ascerta (08714729802976) 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. 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. Indicates a trademark of the Abbott group of companies. Boston Scientific's Express 2 (bare-metal) stent system also received approval for immediate MRI exams.
Safety of Magnetic Resonance Imaging in Patients With - Circulation 5-year data for.
Boston Scientific's ELUVIA Drug-Eluting Stent and Coronary Paclitaxel The MAE rate at 12 months was 5.4 percent, with all MAEs related to TVR. Please be sure to read it. Safety Topic / Subject Enterra II Model 37800 Gastric Electrical Stimulation (GES) System . An official website of the United States government, : An inner shaft, with two radiopaque markers, aids in the placement of the stent. 0
Boston Scientific performed rigorous laboratory testing to demonstrate MRI compatibility.
THE List - MRI Safety 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. Refer to the . Overview of the ELUVIA Drug- Eluting Stent (DES) III. The Express 2 Monorail and Over-the-Wire Coronary Stent Systems have not yet been marketed in any country. 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. 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.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 1.5,3: Conditional 5 More . The Epic Stent should not migrate in this MRI environment. 1.5,3: 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: endstream
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Sterile. 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. When ready to be implanted, the stent is deployed by retracting the exterior shaft of the 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. GMDN Names and Definitions: Copyright GMDN Agency 2015.
Boston Scientific Epic Stent Demonstrates Positive Clinical Outcomes "The Epic Stent is a novel stent platform designed to offer both acute and clinical advantages over older-generation stent systems. Catalog No. Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537 1.888.272.1001 www.BostonScientific.com .
Premarket Approval (PMA) We recommend that you download and review the most current version any time a patient with an Abbott product needs an MRI.
Boston Scientific Promus PREMIER And SYNERGY Drug-Eluting Stent Conditional 6 More. The VICI SDS and VICI RDS VENOUS STENT Systems are intended for the treatment of obstructions and occlusions in the narrowed or blocked venous veins. All rights reserved. Illustrations are artist's representations only and should not be considered as engineering drawings or photographs. 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. Safe More. A Recall Notice, dated 05/14/04, was sent to appropriate hospital personnel. 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. (0.89mm) guidewires. 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. Marlborough, MA 01752-1566 . Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com.
PDF Summary of Safety and Effectiveness Data WALLSTENT with Unistep It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and may be inserted with a balloon catheter which causes . As the stent is exposed to body temperature it expands to appose the duct wall. Use of these devices may cause serious injuries or death. 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. 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. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729861775 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 [?] Coronary data supports safety of paclitaxel and ELUVIA DES IV. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review a list of adverse conditions and effects.
The product, pouch label and carton label are all correct and the correct DFU is in the package. 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. 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. Our manuals contain the latest instructions and information for cardiac physicians, radiologists and MR technologists. 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 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.".
PDF Summary of Safety and Effectivness (SSED)Template 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. If the stent migrates to the heart, it could cause life-threatening injury.
Boston Scientific Corporation Recalls VICI VENOUS STENT System and VICI 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. Note: If you need help accessing information in different file formats, see
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2022 Boston Scientific Corporation or its affiliates. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Once you have completed the checklist, select the Program MRI Settings button to enable MRI Settings. 38948-8607. MRI is an effective method of providing detailed diagnosis for many types of injuries and conditions, including cardiovascular disease. Epic Stent Boston Scientific, www.bostonscientific.com. NOTE: Device diagnostic data may be suspended or cleared when MRI Settings are enabled. Furthermore, outcomes for very complex (TASC C/D) lesions were similar to those reported for less complex (TASC A/B) lesions. 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 It was launched in the United States in May of 2012. :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\. 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. hbbd``b` C9E tk`/@PHA,HyM! The stent is constrained within a 6F delivery system. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements. 1) Confirm MRI readiness. 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 [?] Reproduced with Permission from the GMDN Agency. Indications for Use The Wallstent Venous Endoprosthesis is indicated for improving central venous diameter . 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. Note: Boston Scientific is not responsible for the correct use of codes on submitted claims; this informationdoes not constitute reimbursement or legal advice.
The Boston Scientific Epic Stent Continues to Demonstrate Positive 2022 Boston Scientific Corporation or its affiliates. Date of Panel Recommendation: None Premarket Approval Application (PMA) Number: P150003/S058 Date of FDA Notice of Approval: August 10, 2020 AccessGUDID - Ascerta Firm (08714729861720)- Ureteral Stent. 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). Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review how data will be handled by each system. 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. Many of our pacemakers (leadless and traditional), ICDs, ICMs, CRT-Ds, CRT-Ps, pressure sensors, heart valves, occluders and annuloplasty rings are MR Conditional. CAUTION: These products are intended for use by or under the direction of a physician. No amputations were reported through the 12-month period. Coils, Filters, Stents, and Grafts More.
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. Made in USA 5905 Nathan Lane, Plymouth, MN 55442, USA. Find products, medical specialty information, and education opportunities. The prospective, single-arm ORION trial enrolled 125 patients at 28 sites in the United States. This scientific statement is intended to summarize and clarify issues regarding the safety of MR imaging in patients with cardiovascular devices. Device Size Text, specify: 75 cm Effective Length, Device Size Text, specify: 40 mm Stent Length, Device Size Text, specify: 10 mm Stent Diameter. The positive data support the Boston Scientific goal of delivering products designed to reduce the need for reinterventions and help lower overall healthcare costs. 121 0 obj
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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 This includes continuous monitoring of the patient's hemodynamic function. %PDF-1.4
%
Stent delivery system (SDS): A system that delivers a biliary stent to a target site within the bile duct and then deploys the stent. The stent is a laser cut self-expanding stent composed of a nickel titanium alloy(nitinol). The site is secure. If needed, perform capture and sense and lead impedance tests.
AccessGUDID - DEVICE: Epic Vascular (08714729805014) THE List - MRI Safety Patients receiving coronary stents have typically been required to wait approximately two months before receiving an MRI. The Notice described the issue, identified affected product and asked that the use of affected product be discontinued and affected units be segregated. 0.3. The FDA has identified this as a Class I recall, the most serious type of recall. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review a list of adverse conditions and effects. [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. Boston Scientific, www.bostonscientific.com . Class 3 Device Recall Sentinol Nitinol Biliary Stent System. MRI at 3T or 1.5T may be performed immediately following the implantation of the Epic Stent. 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. "The Epic Stent has been very well-received by physicians across the country. Disposable devices associated with implantation may be included. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. f@ 1 0 obj
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Drummond wire (316L SS) orthopedic implant. The revised Express2 bare-metal stent DFU will be available shortly. The ORION clinical data was used to support application for U.S. Food and Drug Administration approval of the Epic Stent System. It may be a continuous tube or a mesh structure in tubular form and is available in a variety of lengths and diameters. "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. 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. Interrogate the device with the Merlin PCS Programmer and Aveir Link Module. Coils, Filters, Stents, and Grafts More. You can search by product, model number, category or family.
AccessGUDID - DEVICE: Ascerta Firm (08714729861720)
C-codesare used for hospital outpatient device reporting for Medicare and some private payers. 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.
Epic Vascular Self-Expanding Stent System - Boston Scientific Newmatic Medical, www.newmaticmedical.com. Instructions for Downloading Viewers and Players. The results found that the stent was MRI . Boston Scientific Sentinol Self-Expanding Nitinol Biliary Stent System with Over-the-Wire Delivery System. Advances in magnetic resonance (MR) imaging and MR angiography over the last 2 decades have led to MR becoming an increasingly attractive imaging modality. Several of these demonstrated magnetic field interactions. Instructions for Downloading Viewers and Players, Class 3 Device Recall Sentinol Nitinol Biliary Stent System.