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Boston Scientific 2 Agenda I. 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. Patients experienced significant clinical improvement from baseline to twelve months based on feedback from validated questionnaires evaluating walking distance, speed and stair climbing. 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. 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).? 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. "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. Cautionary Statement Regarding Forward-Looking Statements. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 1.5 . 38948-8607. The Epic Nitinol Stent System received CE Mark approval and was launched in Europe and other international markets in 2009. Our manuals contain the latest instructions and information for cardiac physicians, radiologists and MR technologists. Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . Note: Boston Scientific is not responsible for the correct use of codes on submitted claims; this informationdoes not constitute reimbursement or legal advice. "The Epic Stent is a novel stent platform designed to offer both acute and clinical advantages over older-generation stent systems. 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 [?] 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. 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." 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. 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. 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. The Boston Scientific Epic Stent Continues to Demonstrate Positive Coils, Filters, Stents, and Grafts More. The information provided here is not intended to provide information to patients and the general public. No deaths have been reported. Boston Scientific Promus PREMIER And SYNERGY Drug-Eluting Stent 2*Uax?t} For information, visit MagneticResonanceSafetyTesting.com 2022 MRI Textbook Boston Scientific performed rigorous laboratory testing to demonstrate MRI compatibility. The Sentinol Nitinol Stent System is comprised of two components: the implantable . BSC began marketing the product internationally following approval in September 2001. 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 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. 2022 Boston Scientific Corporation or its affiliates. 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. PDF Platinum Chromium Coronary Stent System REBEL - Food and Drug Can I undergo MRI or scanner testing with a stent? Marlborough, MA 01752-1566 . Boston Scientific Sentinol Self-Expanding Nitinol Biliary Stent System with Over-the-Wire Delivery System. All other trademarks are the property of their respective owners. MRI is an effective method of providing detailed diagnosis for many types of injuries and conditions, including cardiovascular disease. Once you have completed the checklist, select the Program MRI Settings button to enable MRI Settings. MRI at 3T or 1.5T may be performed immediately following the implantation of the Epic Stent. Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. 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. 5-year data for. THE List - MRI Safety MR imaging provides excellent spatial . CAUTION: These products are intended for use by or under the direction of a physician. Orthopedic Implants, Materials, and Devices More. 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 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. DVAz~U|OH_P&xuN)Z6:U<0GI+LQj%]mr2&4SCjyWlQq0H[-2vmu5*Q]zp`MocdS.I>^fp~DEBdo(t Search for coronary and peripheral disease and valve disease IFUS. Class 3 Device Recall Sentinol Nitinol Biliary Stent System. The Epic Stent should not migrate in this MRI environment. For more information, please visit: www.bostonscientific.com. A Recall Notice, dated 05/14/04, was sent to appropriate hospital personnel. May be removed prior to MRI and replaced after the MRI exam. Indicates a third party trademark, which is property of its respective owner. The stent is a laser cut self-expanding stent composed of a nickel titanium alloy(nitinol). The .gov means its official.Federal government websites often end in .gov or .mil. 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 . This cautionary statement is applicable to all forward-looking statements contained in this document. As the stent is exposed to body temperature it expands to appose the duct wall. For more information, please visit: www.bostonscientific.com. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. The MAE rate at 12 months was 5.4 percent, with all MAEs related to TVR. Magnetic Resonance Imaging (MRI) Safety for Boston Scientific Peripheral Products PDF, 272.0 KB. Refer to the . Learn the steps for safely preparing Abbotts MRI-Ready GallantTM and EntrantTM High Voltage ICD and CRT-D devices for an MRI scan. 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 ORION clinical data was used to support application for U.S. Food and Drug Administration approval of the Epic Stent System. 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 If needed, perform capture and sense and lead impedance tests. A stent delivery system for a balloon expandable stent consists Fortunately, the devices that exhibited po . 0 Use this database for arrhythmia, heart failure and structural heart products. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. Read our privacy policy to learn more. 59 0 obj <> endobj Precautions A tracking/verification form is asked to be returned to Boston Scientific and arrangements will be made for retuning the affected product. "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.". Advances in magnetic resonance (MR) imaging and MR angiography over the last 2 decades have led to MR becoming an increasingly attractive imaging modality. 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. 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 [?] Dont scan the patient if any adverse conditions are present. This site uses cookies. Furthermore, outcomes for very complex (TASC C/D) lesions were similar to those reported for less complex (TASC A/B) lesions. 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. Boston Scientific's ELUVIA Drug-Eluting Stent and Coronary Paclitaxel PDF Summary of Safety and Effectiveness It may be a continuous tube or a mesh structure in tubular form and is available in a variety of lengths and diameters. Please be sure to read it. Before sharing sensitive information, make sure you're on a federal government site. 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. Major adverse events are defined as death within 30 days, myocardial infarction (MI, or heart attack) occurring during hospitalization, target vessel revascularization (TVR) through nine months and amputation of the treated limb through nine months. 38948-8607. "Following the recent presentation of our nine-month data, the 12-month ORION data continue to show very strong clinical outcomes," said Dr. Clair. 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. Coronary data supports safety of paclitaxel and ELUVIA DES IV. Use this database for coronary intervention, peripheral intervention and valve repair products. The FDA has identified this as a Class I recall, the most serious type of recall. %PDF-1.5 % 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. 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: The TAXUS stent system is the first drug-eluting stent to receive approval for immediate post-procedure MRI. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. THE List - MRI Safety An inner shaft, with two radiopaque markers, aids in the placement of the stent. PDF Summary of Safety and Effectiveness Data WALLSTENT with Unistep 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. Sterile. MRI Safety for Cardiovascular Products I Abbott The C-code used for this product is C1876, Stent, non-coated/non-covered with delivery system. Stent delivery system (SDS): A system that delivers a biliary stent to a target site within the bile duct and then deploys the stent. Boston Scientific Corporation . The following pages are intended for medical professionals and provide information on the proper use of products (medical devices, etc.) Patients receiving coronary stents have typically been required to wait approximately two months before receiving an MRI. 0.3. 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. Coils, stents, filters and vascular grafts have been evaluated relative to the use of MR systems. The Notice described the issue, identified affected product and asked that the use of affected product be discontinued and affected units be segregated. 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. 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. One lot of one catalog number of the Sentinol Nitinol Biliary Stent System may have been packaged in a Sentinol nitinol Vascular outer carton. 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 By using this site, you consent to the placement of our cookies. MRI Safety Home Alternatively, you can also use the latest MRI Manuals to determine scan parameters. Abbotts MRI-Ready High Voltage Device Setup for Gallant and Entrant ICD and CRT-Ds (11:45). With our stent systems, MRI analyses can now be performed immediately.". 7th.Ine!Y+mOTqDm/`*XBagB8GzXov8P1zluIz y "0!rab/dMwLtX1@_18TUWW\ T/~dc/mRE The Express Coronary Stent System was granted approval by Boston Scientific's notified body (TUV Rheinland) to permit CE marking June 18, 2001. 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. 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. Catalog No.