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. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. The delivery system is of coaxial design with an exterior shaft to protect and constrain the stent prior to deployment. 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. }7MWJ!%c. Search for arrhythmia, heart failure and structural heart IFUs. Conditional 6 More. 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. 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 Express Coronary Stent System was granted approval by Boston Scientific's notified body (TUV Rheinland) to permit CE marking June 18, 2001. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. "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. endstream endobj startxref Can I undergo MRI or scanner testing with a stent? Disposable devices associated with implantation may be included. 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. C-codesare used for hospital outpatient device reporting for Medicare and some private payers. Boston Scientific Promus PREMIER And SYNERGY Drug-Eluting Stent You can search by product, model number, category or family. The C-code used for this product is C1876, Stent, non-coated/non-covered with delivery system. All rights reserved. PDF Summary of Safety and Effectiveness Data WALLSTENT with Unistep 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 [?] Search for coronary and peripheral disease and valve disease IFUS. 2*Uax?t} Following is some high-level information about preparing for and administering an MRI with patients with a leadless pacemaker, traditional pacemaker, ICD, CRT-D or CRT-P. H7YPnf'Sq-. The following pages are intended for medical professionals and provide information on the proper use of products (medical devices, etc.) 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. You can search by model number or product category. It may be a continuous tube or a mesh structure in tubular form and is available in a variety of lengths and diameters. 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 For more information, please visit: www.bostonscientific.com. An inner shaft, with two radiopaque markers, aids in the placement of the stent. 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/. 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. Magnetic Resonance MR Conditional 3.0 tesla temperature information 1.5 . THE List - MRI Safety 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. Please be sure to read it. Note: Boston Scientific is not responsible for the correct use of codes on submitted claims; this informationdoes not constitute reimbursement or legal advice. The stent is constrained within a 6F delivery system. Drummond wire (316L SS) orthopedic implant. %PDF-1.4 % Find out who we are, explore careers at the company, and view our financial performance. Platinum Chromium Coronary Stent System (Monorail) Device Procode: Applicant's Name and Address: NIQ . The Express 2 Monorail and Over-the-Wire Coronary Stent Systems have not yet been marketed in any country. Several of these demonstrated magnetic field interactions. The Notice described the issue, identified affected product and asked that the use of affected product be discontinued and affected units be segregated. Furthermore, outcomes for very complex (TASC C/D) lesions were similar to those reported for less complex (TASC A/B) lesions. Dont scan the patient if any adverse conditions are present. The Boston Scientific Epic Stent Continues to Demonstrate Positive The MRI parameter settings are selected at the physician's discretion. 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News Releases - Boston Scientific 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. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Be sure to check the lead combination(s) (if applicable) to ensure you select the correct settings. Our manuals contain the latest instructions and information for cardiac physicians, radiologists and MR technologists.