No amputations were reported through the 12-month period. 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. Safety Topic / Subject Enterra II Model 37800 Gastric Electrical Stimulation (GES) System . Refer to the manuals for CardioMEMS HF System or MR Conditional ICMs for details about MRIs with those devices. Boston Scientific Promus PREMIER And SYNERGY Drug-Eluting Stent Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Disposable devices associated with implantation may be included. Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words. "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. PDF Summary of Safety and Effectiveness 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. Coils, Filters, Stents, and Grafts More. As a result, DFUs for stent systems containing metal usually recommend a waiting period of approximately two months from the time of implantation until an MRI can be performed safely. These devices are considered MR Unsafe. There have been 17 complaints and reported injuries related to this issue. 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. Epic Vascular Self-Expanding Stent System - Boston Scientific Sterile. 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. When ready to be implanted, the stent is deployed by retracting the exterior shaft of the delivery system. 1) Confirm MRI readiness. The Express 2 Monorail and Over-the-Wire Coronary Stent Systems have not yet been marketed in any country. The following pages are intended for medical professionals and provide information on the proper use of products (medical devices, etc.) 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. The Notice described the issue, identified affected product and asked that the use of affected product be discontinued and affected units be segregated. All rights reserved. This site uses cookies. 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. "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. 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. Safety of Magnetic Resonance Imaging in Patients With - Circulation ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. 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. 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. We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. THE List - MRI Safety (,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 Drummond wire (316L SS) orthopedic implant. MRI Safety Home The Merlin PCS Programmer will print to the default printer (internal printer, external printer or PDF). Marlborough, MA 01752-1566 . Within US to KY, MA, NC, NH, NJ, PA, TX, VA, WA. With our stent systems, MRI analyses can now be performed immediately.". f@ The TAXUS stent system is the first drug-eluting stent to receive approval for immediate post-procedure MRI. Introduction II. 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. Follow the checklist instructions within Merlin PCS Programmer. The delivery system is of coaxial design with an exterior shaft to protect and constrain the stent prior to deployment. The results found that the stent was MRI . Read our privacy policy to learn more. Once you have completed the checklist, select the Program MRI Settings button to enable MRI Settings. @Bd!$7@"rAOgx
Platinum Chromium Coronary Stent System (Monorail) Device Procode: Applicant's Name and Address: NIQ . If a device is not shown in the list, it is not MR Conditional. "The Epic Stent has been very well-received by physicians across the country. Coils, stents, filters and vascular grafts have been evaluated relative to the use of MR systems. 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. Search for coronary and peripheral disease and valve disease IFUS. These devices are considered MR Unsafe. of Abbott Medical Japan GK. Class 3 Device Recall Sentinol Nitinol Biliary Stent System 2022 Boston Scientific Corporation or its affiliates. Orthopedic Implants, Materials, and Devices More. Coils, Filters, Stents, and Grafts More. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and may be inserted with a balloon catheter which causes . 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/. The prospective, single-arm ORION trial enrolled 125 patients at 28 sites in the United States. 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. 2*Uax?t} This press release contains forward-looking statements. We recommend that you download and review the most current version any time a patient with an Abbott product needs an MRI. Dry Pad 9 x 9 with Silver Antimicrobial Agent. C-codesare used for hospital outpatient device reporting for Medicare and some private payers. Fortunately, the devices that exhibited po . The Epic Nitinol Stent System received CE Mark approval and was launched in Europe and other international markets in 2009. 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. 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 Corporation One Boston Scientific Place Natick, MA 01760-1537 1.888.272.1001 www.BostonScientific.com . Instructions for Downloading Viewers and Players, Class 3 Device Recall Sentinol Nitinol Biliary Stent System. DVAz~U|OH_P&xuN)Z6:U<0GI+LQj%]mr2&4SCjyWlQq0H[-2vmu5*Q]zp`MocdS.I>^fp~DEBdo(t
AccessGUDID - DEVICE: Ascerta (08714729802976) Boston Scientific, www.bostonscientific.com . MRI Safety for Cardiovascular Products I Abbott 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. Epic Stent Boston Scientific, www.bostonscientific.com. Prior to use, reference the Instructions for Use, inside the product carton (when available) or online for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events. 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. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review how data will be handled by each system. Note: Boston Scientific is not responsible for the correct use of codes on submitted claims; this informationdoes not constitute reimbursement or legal advice. {}(;]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? Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. The information provided here is not intended to provide information to patients and the general public. 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. Precautions
This stent has not been evaluated to determine if it is MR Conditional beyond these conditions. Cautionary Statement Regarding Forward-Looking Statements. 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."
