boston scientific epic stent mri safety

2022 Boston Scientific Corporation or its affiliates. Boston Scientific is recalling the VICI SDS and RDS VENOUS STENT Systems after reports indicate that the stents may migrate or move from where they are initially implanted. 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. PDF 2 7 2 Epic Vascular 2 - Boston Scientific It was launched in the United States in May of 2012. The positive data support the Boston Scientific goal of delivering products designed to reduce the need for reinterventions and help lower overall healthcare costs. Catalog No. 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. It may be a continuous tube or a mesh structure in tubular form and is available in a variety of lengths and diameters. No amputations were reported through the 12-month period. Use this database for arrhythmia, heart failure and structural heart products. The information provided here is not intended to provide information to patients and the general public. We recommend that you download and review the most current version any time a patient with an Abbott product needs an MRI. MRI Safety Home If the stent migrates to the heart, it could cause life-threatening injury. Disposable devices associated with implantation may be included. 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. 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. The default MRI parameter settings are automatically stored in the Abbott MR Conditional device. This scientific statement is intended to summarize and clarify issues regarding the safety of MR imaging in patients with cardiovascular devices. {}(;]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? 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. A tracking/verification form is asked to be returned to Boston Scientific and arrangements will be made for retuning the affected product. 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. PDF Table of Contents - WATCHMAN Illustrations are artist's representations only and should not be considered as engineering drawings or photographs. 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 [?] NOTE: Device diagnostic data may be suspended or cleared when MRI Settings are enabled. 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 For more information, please visit: www.bostonscientific.com. 1.5,3: Conditional 5 More . The C-code used for this product is C1876, Stent, non-coated/non-covered with delivery system. MRI Safety for Cardiovascular Products I Abbott Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Precautions From the FastPath Summary screen, select the Print button to print the Diagnostics and any other relevant reports. By using this site, you consent to the placement of our cookies. 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. News Releases - Boston Scientific 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. Premarket Approval (PMA) Many of our pacemakers (leadless and traditional), ICDs, ICMs, CRT-Ds, CRT-Ps, pressure sensors, heart valves, occluders and annuloplasty rings are MR Conditional. May be removed prior to MRI and replaced after the MRI exam. Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729959915 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 021717889 * Terms of Use Device Description: Ureteral Stent With Side Holes 6Fx28CM CLOSE Device Characteristics Device Record Status Alternative and Additional Identifiers 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. The Merlin PCS Programmer will print to the default printer (internal printer, external printer or PDF). C-codesare used for hospital outpatient device reporting for Medicare and some private payers. endstream endobj startxref Cautionary Statement Regarding Forward-Looking Statements. :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\. All rights reserved. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Can I undergo MRI or scanner testing with a stent? 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. PDF Summary of Safety and Effectiveness The stent is constrained within a 6F delivery system. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Reproduced with Permission from the GMDN Agency. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. 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. The TAXUS stent system is the first drug-eluting stent to receive approval for immediate post-procedure MRI. A Recall Notice, dated 05/14/04, was sent to appropriate hospital personnel. Metal Expandable Biliary Stents - Food and Drug Administration 1) Confirm MRI readiness. endstream endobj 60 0 obj <>>>/Filter/Standard/Length 128/O(v~aIgInj rM)/P -1340/R 4/StmF/StdCF/StrF/StdCF/U( ey,62_ )/V 4>> endobj 61 0 obj <>>> endobj 62 0 obj <> endobj 63 0 obj <>/ExtGState<>/Font<>/ProcSet[/PDF/Text]/Properties<>/Shading<>/XObject<>>>/Rotate 0/TrimBox[24.0 24.0 619.276 865.89]/Type/Page>> endobj 64 0 obj <>stream If a device is not shown in the list, it is not MR Conditional. %PDF-1.5 % Results were presented today by Daniel Clair, M.D., FACS, principal investigator of the . 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. Unless otherwise specified, all product names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. Boston Scientific's ELUVIA Drug-Eluting Stent and Coronary Paclitaxel Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. 0.3. f@ Dry Pad 9 x 9 with Silver Antimicrobial Agent. 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 $Xp7lXcV5ZID?vM1V]kM).? It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and may be inserted with a balloon catheter which causes the device to expand when inflated, or it may self-expand after insertion with a delivery device. No deaths have been reported. "The performance of the Epic Stent in challenging iliac artery lesions and the long-term demonstration of both safety and efficacy of the Epic Stent is another example of our ability to offer patients a durable treatment option for iliac artery disease.". The MAE rate at 12 months was 5.4 percent, with all MAEs related to TVR. The Epic Nitinol Stent System received CE Mark approval and was launched in Europe and other international markets in 2009. ,TFZ3R?ZU,6P;0rY;qC\#*"zgZ71j:clLv^O LHf,xvU8pZ7 9^FHZ|+iL V~G!=}6. This site is Exclusively Sponsored by BRACCO, ENTERRA THERAPY, Gastric Electrical Stimulation (GES), Neurostimulation System, Orthopedic Implants, Materials, and Devices, Cerebrospinal Fluid (CSF) Shunt Valves and Accessories, Hemostatic Clips, Other Clips, Fasteners, and Staples. Platinum Chromium Coronary Stent System (Monorail) Device Procode: Applicant's Name and Address: NIQ . We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. Boston Scientific 2 Agenda I. When ready to be implanted, the stent is deployed by retracting the exterior shaft of the delivery system. The Sentinol Nitinol Stent System is comprised of two components: the implantable endoprosthesis and the stent delivery system. THE List - MRI Safety (,OcEh{[%E#Xl@::9(k]xv# q#fs+[Jb{-$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 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. 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. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review how data will be handled by each system. MRI is an effective method of providing detailed diagnosis for many types of injuries and conditions, including cardiovascular disease. 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. 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 FDA has identified this as a Class I recall, the most serious type of recall. 510(K)s with Product Code = FGE and Original Applicant = BOSTON SCIENTIFIC CORP. Magnetic Resonance MR Conditional 3.0 tesla temperature information Made in USA 5905 Nathan Lane, Plymouth, MN 55442, USA. AccessGUDID - DEVICE: Tria Soft (08714729959915) Boston Scientific Corporation . of Abbott Medical Japan GK. MRI at 3T or 1.5T may be performed immediately following the implantation of the Epic 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. 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. Please be sure to read it. Within US to KY, MA, NC, NH, NJ, PA, TX, VA, WA. AccessGUDID - DEVICE: Ascerta (08714729802976) Epic Stent Boston Scientific, www.bostonscientific.com. The stent is a laser cut self-expanding stent composed of a nickel titanium alloy(nitinol). Overview of the ELUVIA Drug- Eluting Stent (DES) III. The following countries were contacted regarding the recall and all reported that no accounts had affected product in their possession: Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Hong Kong, India, Indonesia, Vietnam, New Zealand, Israel, Korea, Malaysia, Mexico, Philippines, Singapore, South Africa, Taiwan, Thailand, Turkey, Uruguay, Andean & Caaribbean Countries, Cyprus, Balkins, Puerto Rico, Bahrain, Egypt, Jordan, Kuwait, Lebanon, Morocco, Oman, Pakistan, Qatar, Saudi Arabia, Syria, Tunisia, Yemen, United Arib Emirates. GMDN Names and Definitions: Copyright GMDN Agency 2015. Boston Scientific's Express 2 (bare-metal) stent system also received approval for immediate MRI exams. %%EOF 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. Instructions for Downloading Viewers and Players. 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 Safety of Magnetic Resonance Imaging in Patients With - Circulation 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. 2*Uax?t} Data from the first human use NG PROMUS Clinical Trial evaluating the safety and effectiveness of the Promus PREMIER Everolimus-Eluting . 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. Sterile. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Boston Scientific Sentinol Self-Expanding Nitinol Biliary Stent System with Over-the-Wire Delivery System. Refer to the manuals for CardioMEMS HF System or MR Conditional ICMs for details about MRIs with those devices. THE List - MRI Safety BSC began marketing the product internationally following approval in September 2001. THE List - MRI Safety Find out who we are, explore careers at the company, and view our financial performance. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review a list of adverse conditions and effects. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Note: If you need help accessing information in different file formats, see Furthermore, outcomes for very complex (TASC C/D) lesions were similar to those reported for less complex (TASC A/B) lesions. 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. 1.5,3: As the stent is exposed to body temperature it expands to appose the duct wall. Fortunately, the devices that exhibited po, 2D Helical, 35 Fibered Platinum Coil. Advances in magnetic resonance (MR) imaging and MR angiography over the last 2 decades have led to MR becoming an increasingly attractive imaging modality. Patients receiving coronary stents have typically been required to wait approximately two months before receiving an MRI. Instructions for Downloading Viewers and Players, Class 3 Device Recall Sentinol Nitinol Biliary Stent System. ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. All rights reserved. MRI safety testing has shown that the REBEL Stent is MR Conditional and that 2023 Boston Scientific Corporation or its affiliates. Coils, Filters, Stents, and Grafts More. Several of these demonstrated magnetic field interactions. 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). Fortunately, the devices that exhibited po . Safety Topic / Subject Enterra II Model 37800 Gastric Electrical Stimulation (GES) System . It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and may be inserted with a balloon catheter which causes . 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. 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 delivery system is of coaxial design with an exterior shaft to protect and constrain the stent prior to deployment. It is required to program the device to MRI Settings as part of the MRI scan workflow. For more information, please visit: www.bostonscientific.com. Sterile. 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. 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. Patients experienced significant clinical improvement from baseline to twelve months based on feedback from validated questionnaires evaluating walking distance, speed and stair climbing.