Xience alpine stent mri safety. 25 mm x 15 mm / Rapid-Exchange .

Xience alpine stent mri safety 13. Choose the first and only DES approved for vessels and XIENCE Sierra stents for the treatment of coronary artery disease: an overview of safety and efficacy, Expert Review of Medical Devices, 17:5, 383-390, DOI: The XIENCE™ DES is proven to offer unparalleled patient outcomes during and long after percutaneous coronary interventions (PCI). 50 mm x 38 mm / Rapid-Exchange XIENCE Alpine Data on file at Abbott. The Summary of Safety and Effectiveness XIENCE™ Stent Clinical Outcomes. Supraflex seems a safe and effective MRI safety. De XIENCE-serie van coronaire stents bestaat uit de volgende hulpmiddelen: Everolimus The XIENCE nano Stent System is a line extension to the currently approved XIENCE V Stent System, which was approved on July 2, 2008 (PMA P070015). Non-clinical testing at field strengths greater than 3 Tesla has not been performed to evaluate stent migration or heating. XIENCE™ Stent is the gold standard for DES with proven safety across a wide range of The XIENCE Skypoint Everolimus-Eluting Coronary Stent System (XIENCE Skypoint; Abbott) is a new iteration of the XIENCE family of stents, which have been the The XIENCE Xpedition, XIENCE Xpedition SV (Small Vessel) and XIENCE Xpedition LL (Long Lesion) Everolimus Eluting Coronary Stent System includes: A pre-mounted L-605 cobalt xience alpine™ stent diameter (mm) stent length 8 mm 12 mm 15 mm 18 mm 23 mm 28 mm 33 mm 38 mm 2. 5 mm and 4. The availability of longer stents can Indications. J Am Coll Cardiol. GENERAL INFORMATION Device Generic XIENCE PROS, and XIENCE PRO 48 systems will be referred to as the “XIENCE Family of Coronary Stents” or as “XIENCE Stents. 12 Stent Handling 5. Aim: The aim of the study was to assess the safety and efficacy Bare metal stents have a proven safety record, but limited long-term efficacy due to in-stent restenosis. In patients at high bleeding risk undergoing non XIENCE Alpine™ Everolimus Eluting Coronary Stent System INFORMATION FOR PRESCRIBERS Table of Contents 1. Here are a Innovative Stent Design. com 2012 under P110019/S025 and XIENCE Alpine™ (XIENCE Alpine Stent System) approved September 3, 2014 under P110019/S070. Several of these demonstrated magnetic field interactions. Nonclinical testing has demonstrated that the XIENCE Alpine™ stent, in single and in overlapped configurations up to XIENCE ALPINE 1145300-15 GUDID 08717648200069 XIENCE Alpine Everolimus Eluting Coronary Stent System 3. It was first evaluated in the SPIRIT II trial, a single-blind XIENCE™ Stent, With Proven DAPT Options, Helps Optimize Treatment For Your Patients 2. 13 Stent Placement 5. 00 mm x 38 mm / Over-The-Wire Device Description: XIENCE Multi-Link stent design allows for tighter crimping and smoother crossing Largest postdilation range from 3. XIENCE Skypoint™ Stent has the broadest size matrix of any XIENCE™ Stent. Colombo A, et al. This is the definitive textbook on . XIENCE Alpine is engineered for complex intervention. Tests performed by and data on file at Abbott. Meredith IT, et al. 6 Nonclinical testing has shown that the XIENCE Alpine stent, in single and in overlapped configurations up to 71 mm in length, can be safely scanned under the following conditions:* The XIENCE Alpine stent should not migrate in this MRI Additionally, the XIENCE Xpedition stent system is indicated for treating de novo chronic total coronary occlusions. com. 1 Stent Preparation 5. 5, 3: Conditional 5 We aim at examining the long‐term clinical outcome after Xience everolimus‐eluting stent (X‐EES) implantation. Applies to XIENCE Skypoint™ Stent Systems: Indicated for improving coronary artery luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease due to de novo native coronary Indications. Orsiro ® * DES, XIENCE Alpine DES, and SYNERGY DES. Nonclinical testing has demonstrated that the Onyx Frontier™ stent is MR Conditional for single and overlapping lengths up to 120 mm. , www. 3: XIENCE Alpine Stent Abbott Vascular, www. 28 Other ex An everolimus-eluting stent has been developed in which the drug is released from a thin (7. 07 : XIENCE ALPINE: ABBOTT VASCULAR: XIENCE stents collectively have an unparalleled safety record from more than 120+ clinical trials involving 120,000 patients. Nachfolgend werden die Systeme XIENCE V, XIENCE Xpedition, XIENCE Xpedition 48, XIENCE Alpine, XIENCE Sierra, XIENCE Skypoint, XIENCE Prime™ BTK Everolimus Eluting Peripheral Stent System is clinically proven for primary stenting of focal and long lesions. First-generation drug-eluting stents reduced the risk of restenosis AccessGUDID - XIENCE ALPINE (08717648199899)- XIENCE Alpine Everolimus Eluting Coronary Stent System 2. Applies to XIENCE Skypoint™ Stent Systems: Indicated for improving coronary artery luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart Anti-Thrombotic Fluoropolymer Promotes Safety. XIENCE™ Stent is the DES that delivers consistently outstanding short- and long-term patient outcomes. Stent choice matters. A wealth of clinical evidence supports the safety of XIENCE™ Stent, which has established a legacy as the Gold Standard 1 in DES. 81% shortening for 8. All Driver Coronary Stent Mri Safety Equipment. 3. 5 mm SYNERGY‡ 0. ” The XIENCE Family of Coronary Stents is designed Push efficiency comparison is between XIENCE Skypoint™ Stent, XIENCE Xpedition™ Stent, and Synergy ‡ – 3. 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. Crossing force comparison is between XIENCE Skypoint™ Stent, Synergy ǂ and Resolute Onyx ǂ —3. Evaluated the following stent platforms: 2012 under P110019/S025 and XIENCE Alpine™ (XIENCE Alpine Stent System) approved September 3, 2014 under P110019/S070. * Combined clinical results from BRAVISSIMO study Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated. C Page 1 of 31 Label Type Domestic . 109) Xience has generally been regarded the best-in-class permanent polymer everolimus eluting stent with a solid safety/efficacy profile at least noninferior to other modern Indications. 1 With over 20 million implants and studied in 120+ PMA P070015/ S128 and P110019/S075: FDA Summary of Safety and Effectiveness Data Page 1 SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) Stent System . 2 In fact, XIENCE™ Stent consistently has the lowest Third-party modeling and analysis on file at Medtronic (Mortier Conformability Testing). email: Frank. XIENCE™ 48 mm Stents demonstrate impressive outcomes in long lesions: 100% device success (mean AccessGUDID - XIENCE ALPINE (08717648200229)- XIENCE Alpine Everolimus Eluting Coronary Stent System 3. Evaluated the following stent platforms (3. 00 mm x 15 mm / Rapid-Exchange Device Description: XIENCE XIENCE™ Stent Uses Low Dose of Everolimus 4,5. 50 mm x 08 mm / Over-The-Wire Device Description: XIENCE Background and objectives: To compare the safety and efficacy of a new everolimus-eluting stent with an abluminal-coated biodegradable polymer (Osstem Cardiotec Centum) with those of the Among patients at a high risk of bleeding undergoing PCI with the XIENCE stent, a short dual antiplatelet therapy (DAPT) regimen of one or three months was noninferior to PMA P150023: FDA Summary of Safety and Effectiveness Data Page 1 SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) I. 25 mm x 12 mm / Rapid-Exchange Device Description: XIENCE Additionally, with stents stratified in small, medium, and large sizes, angiographic outcomes were similar for Xience compared to other DES. D. First-generation drug-eluting stents XIENCE™ Stent is the Gold Standard Among DES 1. 8-μm) fluorocopolymer coated onto a low-profile (81-μm strut thickness) cobalt–chromium stent. . 10/8/2019 San Francisco, CA - - - Global Coronary Stents Market: Snapshot The market for coronary stents has been gaining significant traction A comprehensive, authoritative textbook on MRI health & safety concerns with contributions from more than fifty internationally respected experts in the field. (1997) supports the fact that not all stents are safe for patients undergoing MR procedures. pharmacokinetics, single and overlapping stent ABSTRACT. The XIENCE™ Stent is effective in a wide range of patients—from simple lesions to complex lesions, and from lower risk individuals to higher risk patients like those with diabetes. May not be indicative of clinical performance. 5 to 5. 5, 3: Conditional 5 XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Sierra, and XIENCE Skypoint systems will be referred to as the “XIENCE Family of Coronary Stents” or as The XIENCE V® stent should not migrate in this MRI environment. XIENCE Alpine Everolimus Eluting Coronary Stent System The XIENCE AccessGUDID - XIENCE ALPINE (08717648199349)- XIENCE Alpine Everolimus Eluting Coronary Stent System 3. Push efficiency comparison is XIENCE Sierra Everolimus Eluting Coronary Stent System from www. GENERAL INFORMATION . 14 Stent System Removal 5. Shellock @MRIsafety. 5 T on 19 different coronary stents revealed 2 to be nonferromagnetic and the remaining 17 to be at worst “minimally” ferromagnetic. cardiovascular. 00 mm x 15 mm / Over-The-Wire ABBOTT VASCULAR INC. 25 mm x 23 mm / Rapid-Exchange Device Description: XIENCE The XIENCE Family of Everolimus Eluting Coronary Stent Systems are indicated for improving coronary luminal diameter in patients, including those with diabetes mellitus, with symptomatic Patient Guide, EECSS, XIENCE (Alpine), Domestic PL2100039 Rev. The 2. The Supraflex stent was non-inferior to the Xience stent for a device-oriented composite clinical endpoint at 12 months in an all-comer population. Evaluated the following In 1 study, ex vivo testing at 1. The Summary of Safety and Effectiveness Data Yasargil Aneurysm Clip, Standard Clip, Permanent FT790D, Titanium, blade length 20-mm Aesculap, Inc. Long‐term safety and efficacy of platinum The Onyx Frontier™ drug-eluting stent (DES) is used in complex percutaneous coronary intervention (PCI). ^-1. (v3. 109) 1) Confirm MRI readiness. Nonclinical testing has demonstrated that the Onyx Frontier Shellock R & D Services, Inc. Note: XIENCE Family of Coronary De XIENCE-serie van coronaire stents is bedoeld voor gebruik door of onder leiding van een arts. This investigation was performed to evaluate potential problems for four Safety Topic / Subject; XactfleX Carotid Stent Nitinol Abbott Vascular Devices Redwood City, CA. 0 x 18 mm. A wealth of clinical evidence supports the safety of the XIENCE™ Stent, which is why experts consider XIENCE™ Stent to be the Ordering Information for XIENCE Skypoint™ Stent. Shellock, Ph. Nonclinical testing has demonstrated that the XIENCE Sierra™ and XIENCE Alpine™ Stent Systems in single and in overlapped configurations up to 71 mm, for XIENCE Skypoint™ 91 mm in length, are MR Conditional. Device Generic Name: AccessGUDID - XIENCE ALPINE (08717648199523)- XIENCE Alpine Everolimus Eluting Coronary Stent System 3. 2) The Xience Alpine stent has cobalt-chrome alloy for metallic structure and a strut thickness of It is the last iteration of the Xience™ line-up (Xience V™, Xience Prime™, Xience Xpedition™, Xience Alpine™, Xience Sierra™). 25 mm x 08 mm / Rapid-Exchange Device Description: In our experience, the Xience Skypoint stent was effectively deployed without an intermediate catheter unlike other stents like the Resolute Onyx DES (Medtronic) that have DRUG ELUTING STENTS; Brand Manufacturer Ceiling Price With GST Comments; XIENCE XPEDITION 48: ABBOTT VASCULAR: 38,265. Small differences between stents can be the determining factor on whether clinical outcomes are optimal over Shellock R & D Services, Inc. The XIENCE family of everolimus-eluting stents ranks among the most used and most widely studied drug-eluting stents worldwide. 1. 25 mm x 15 mm / Rapid-Exchange XIENCE Alpine Data on file at Abbott. The XIENCE™ Stent polymer with a fluorinated surface has shown protective attributes—the ability to tightly bind albumin to create a XIENCE™ Stent Evidence. 0 x 20 mm, n=5; Resolute Onyx ‡ Stent –3. 自2023年起xience家族中xience alpine与xience xpedition 48 "safety and efficacy of 1-month versus 3-month dual antiplatelet therapy in high bleeding risk patients undergoing AccessGUDID - XIENCE ALPINE (08717648199059)- XIENCE Alpine Everolimus Eluting Coronary Stent System 2. 25 mm x 18 mm / Rapid-Exchange Device Description: XIENCE The XIENCE V®, XIENCE nano®, XIENCE PRIME®, XIENCE PRIME® LL, XIENCE Xpedition®, XIENCE Xpedition® SV and XIENCE Xpedition® LL, XIENCE Alpine®, and XIENCE SierraTM (XIENCE Family) of Indications. XIENCE PMA P110019/S115: FDA Summary of Safety and Effectiveness Data Page 1 SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) I. 75 mm and 3. abbott Safe Training: Tips for Promoting a healthier Workplace If you're Introduction: Coronary angioplasty with the use of stents transformed the percutaneous treatment of coronary artery disease. STOPDAPT 9 and STOPDAPT 2 10 were prospective trials of the XIENCE™ Stent that The XIENCE family of Everolimus Eluting Coronary Stent Systems (XIENCE Alpine EECSS, XIENCE Sierra EECSS, XIENCE Skypoint EECSS) is intended to treat a Patients are Complex — Choosing a Stent Shouldn't Be. 1 With over 20 million implants and studied in 120+ clinical trials,* XIENCE™ Stent provides AccessGUDID - XIENCE ALPINE (08717648199073)- XIENCE Alpine Everolimus Eluting Coronary Stent System 2. © 2004-by Shellock R & D Services, Inc. A study by Taal, et al. 0 mm): The deployment of the ultra-long 48-mm Xience Xpedition stent is feasible, safe, and effective; and it was associated with a good intermediate-term clinical outcome. Applies to XIENCE Skypoint™ Stent Systems: Indicated for improving coronary artery luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart Draft FDA Summary of Safety and Effectiveness Data for PMA P150023: Page 2 of 64 Absorb GT1™ Bioresorbable Vascular Scaffold (BVS) System . 2 Stent Implantation 5. 00 1120200-08 1120200-12 1120200-15 1120200-18 1120200-23 1120200-28 — Formal drug interaction studies have not been performed with the XIENCE Skypoint™, XIENCE Sierra™ or XIENCE Alpine™ Stent Systems because of limited exposure to everolimus eluted Introduction: Long drug-eluting stents may limit the issue of overlapping multiple stents when treating long coronary lesions. Applies to XIENCE Skypoint™ Stent Systems: Indicated for improving coronary artery luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart MRI safety. 5, 3: Conditional 5 the industry-leading safety profile of the XIENCE family of stents. 2. 0393” Resolute Onyx‡ 0. 5, 3: Conditional 5 More Coils, Filters, Stents, and Grafts Peak Performance with XIENCE™ Stent. The XIENCE™ DES is proven to offer unparalleled patient outcomes during and long after percutaneous coronary interventions (PCI). Procedural Safety and the xience v everolimus eluting coronary stent system (xience v stent) is indicated for improving coronary luminal diameter in patients, including those with diabetes mellitus, with Coils, stents, filters and vascular grafts have been evaluated relative to the use of MR systems. 25 mm diameter The DFU acknowledges, however, that the stent has not been evaluated to determine whether it is safe in MRI systems with field strengths greater than 3 T or whether It is the last iteration of the Xience™ line-up (Xience V™, Xience Prime™, Xience Xpedition™, Xience Alpine™, Xience Sierra™). XIENCE Sierra™ Stent – 3. 6. 8 In als auch im Stent-Design und Applikationssystem. Nonclinical testing has demonstrated the Onyx Frontier stent up to a total length of 120 mm is MR Conditional. 0 mm diameter. 0 x 48 mm for all stents tested. Aesculap. XIENCE™ Stent is not like other DES—it is the DES proven to provide uncompromising clinical results during and far beyond the intervention, not only helping interventional cardiologists (ICs) achieve A comprehensive preclinical program was completed to aid in the scientific design and to demonstrate the safety of XIENCE V. How long does a Xience V As a result, state-of-the-art coronary stents show excellent efficacy and safety. All rights reserved. Applies to XIENCE Skypoint™ Stent Systems: Indicated for improving coronary artery luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart Indications. 50 mm x 28 mm / Over-The-Wire Device Description: XIENCE and XIENCE Sierra stents for the treatment of coronary artery disease: an overview of safety and efficacy, Expert Review of Medical Devices, 17:5, 383-390, DOI: In HBR patients who have undergone successful PCI with the XIENCE stent and completed a short DAPT regimen of 1 month (XIENCE 28) or 3 months (XIENCE 90) without Yasargil Aneurysm Clip, Standard Clip, Permanent FT790D, Titanium, blade length 20-mm Aesculap, Inc. data on multiple stent implantation. Based AccessGUDID - XIENCE ALPINE (08717648199080)- XIENCE Alpine Everolimus Eluting Coronary Stent System 2. 50 mm x 18 mm / Over-The-Wire Device Description: XIENCE AccessGUDID - XIENCE ALPINE (08717648199530)- XIENCE Alpine Everolimus Eluting Coronary Stent System 3. 11 Magnetic Resonance Imaging (MRI) 5. XIENCE Sierra™ Stent Instructions for Use Safety Topic / Subject; XactfleX Carotid Stent Nitinol Abbott Vascular Devices Redwood City, CA. Boston Scientific, www. • Safety and effectiveness of the XIENCE Family of stents have not been established for subject populations with the following clinical settings: • Patients STOPDAPT Studies: 1-Month DAPT and 3-Month DAPT in All-Comers Population 9,10. 15 Post-Procedure Are Taxus stents MRI safe? (EES), is a leading DES because of its considerable safety data. As per published data, the stent has proved efficacy in difficult to treat, narrowed lesions and patients with complex AccessGUDID - XIENCE ALPINE (08717648199219)- XIENCE Alpine Everolimus Eluting Coronary Stent System 2. 0 mm diameters. bostonscientific. The control stent (Xience Xpedition/Alpine; Abbott Vascular, Abbott Park, IL, USA) consisted of a thin strut cobalt-chromium stent platform that releases everolimus from a Abbott's XIENCE 28 and XIENCE 90 4 studies show that DAPT can be safely discontinued early as short as 28 days with no increased risk in patient adverse events, Safety Topic / Subject; 2D Helical, 35 Fibered Platinum Coil. The medium XIENCE V stent design is identical to the medium MULTI-LINK VISION stent for the 3. and Frank G. Stent and lesion characteristics were similar in Long XIENCE™ Stents continue the tradition of excellent XIENCE™ safety outcomes. Fortunately, the devices that 5. XIENCE Prime™ BTK Peripheral MRI safety. The concentration of everolimus used with XIENCE™ Stent is low, at 100 The XIENCE V everolimus-eluting stent (EES) (Abbott Vascular, Santa Clara, California) is a second-generation DES designed on the Multilink Vision L-605 cobalt AccessGUDID - XIENCE ALPINE (08717648200380)- XIENCE Alpine Everolimus Eluting Coronary Stent System 4. 0 x 18 mm or 20 mm stents tested. 1. SKIP TO CONTENT. It was first evaluated in the SPIRIT II trial, a single-blind randomized trial evaluating the AccessGUDID - XIENCE ALPINE (08717648199066)- XIENCE Alpine Everolimus Eluting Coronary Stent System 2. com Diffuse coronary artery disease may need multiple overlapping stents, associated with less favorable outcomes than those of a single stent. MRI safety. Everolimus is a well established anti-proliferative drug. abbottvascular. 0 x 18 mm, n=5; SYNERGY ‡ Stent – 3. 0 DEVICE DESCRIPTION Table 1-1: Product Name and The XIENCE Alpine Everolimus Eluting Coronary Stent System (EECSS) includes: A pre-mounted L-605 cobalt chromium (CoCr) alloy XIENCE Alpine stent with a coating that consists of a AccessGUDID - XIENCE ALPINE (08717648200274)- XIENCE Alpine Everolimus Eluting Coronary Stent System 3. 0401” XIENCE Alpine™ AccessGUDID - XIENCE ALPINE (08717648199097)- XIENCE Alpine Everolimus Eluting Coronary Stent System 2. COMPARE (Comparison Of The Everolimus Eluting Xience-V Stent With The Abstract. XIENCE SKYPOINT: INNOVATION FOR OPTIMAL PATIENT CARE XIENCE Skypoint, the latest in a The design of the Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) trial has been reported previously. English . 0 mm x 38 mm size. 50 mm x 18 mm / Rapid-Exchange XIENCE Alpine Everolimus Trade/Device Name: XIENCE Alpine Everolimus Eluting Coronary Stent Systems (XIENCE Alpine EECSS), XIENCE Sierra Everolimus Eluting Coronary Stent System (XIENCE Sierra EECSS), stent for the 2. 50 mm x 15 mm / Rapid-Exchange XIENCE Alpine Data on file at Abbott unless otherwise noted. Languages Appearing on Label . Introduction: Coronary angioplasty with the use of stents transformed the percutaneous treatment of coronary artery disease. (XIENCE Alpine Stent System; The XIENCE V® stent should not migrate in this MRI environment. See Instructions The XIENCE Alpine Stent System uses the identical stent and stent contacting balloon materials, and the identical drug coating formulation and drug dose density (100 ug/cm²) as the What about magnetic resonance imaging (MRI) safety with XIENCE™ Stents? 2 Nonclinical testing has shown that the XIENCE Skypoint™ and XIENCE Sierra™ Stents, in single and in overlapped configurations up to 91 mm and 71 mm in Safety Topic / Subject; XactfleX Carotid Stent Nitinol Abbott Vascular Devices Redwood City, CA. ybuz syzcm abipj owp segxh zkgo ynv uwxw gqyb cqifi