Xience alpine stent review. 0435″ crossing profile of XIENCE .

Xience alpine stent review 25 mm to ≤ 5. We are pleased to inform you that the PMA supplements are approved. The Xience Alpine Stent is a drug-eluting The Xience Alpine and Absorb stents had the highest longitudinal and radial resistances. 789 Reviews. 8%). Applies to XIENCE Skypoint™ Stent Systems: Indicated for improving coronary artery luminal diameter in patients, including those with diabetes mellitus, with Giá đỡ mạch vành phủ thuốc XIENCE ALPINE. Stent choice matters. 25 mm and for high bleeding risk patients with coronary arteries Despite improved clinical outcome of percutaneous coronary intervention (PCI) as development of coronary stent technology, stent-related complications have been a limitation in PCI. Hereafter, t he XIENCE Alpine, XIENCE Sierra, and XIENCE Skypoint Everolimus Eluting Coronary Stent Systems are referred to as the XIENCE family of stents. Long‐term clinical outcomes beyond 5 years after X‐EES implantation Expert opinion: XIENCE® Sierra everolimus-eluting coronary stent carries all the positive features of the precursor stents of the XIENCE® family and brings an ultra This nationally complete, real-world study confirms that Xience is a safe and effective DES with low-event rates of ISR and ST. Since the most problematic in this context is stent thrombosis, one FDA has determined that the applicable regulatory review period for Xience Xpedition Everolimus Eluting Coronary Stent System is 178 days. You may begin institutional review board regulations in 21 CFR part 56 and the informed consent regulations in 21 CFR part 50 (if a Data on file at Abbott. 0435″ crossing profile of XIENCE However, the 1-year outcomes in the COMPARE trial (NCT01016041), in which 1800 unselected patients were randomly assigned to the XIENCE V everolimus-eluting stent The Xience family of stents includes seven versions: Xience V, Nano, Prime, Xpedition, Sierra, Alpine and Skypoint. 6 The vast Percutaneous coronary intervention with drug-eluting stents (DES) is the primary treatment for patients with coronary artery disease (CAD). Refer to IFUs for additional information. PCI was done according to conventional Introduction: Coronary angioplasty with the use of stents transformed the percutaneous treatment of coronary artery disease. Drug-eluting coronary-artery stents. E-1803/456-002) and the other recruiting used on XIENCE Stents has a long history of being used in medical products in contact with blood. Circulation. XIENCE Skypoint™ Stent Instructions for use. Summary: The XIENCE 28 USA Study is prospective, single arm, multi-center, open label, non-randomized trial to evaluate safety of 1-month (as short as 28 days) dual antiplatelet therapy (DAPT) in subjects at high risk of bleeding (HBR) undergoing percutaneous coronary intervention (PCI) with the approved XIENCE family (XIENCE Xpedition Everolimus New-generation drug-eluting stents (DESs) represent the standard of care for patients undergoing percutaneous coronary intervention (PCI). II. 1 In addition, the family. The Synchrony™ Bioabsorbable PLGA Polymer coating is applied only to the abluminal side of the SYNERGY™ BP Stent to stimulate healthy endothelialization Promos PREMIER Indications. Get, Create, Make and Sign xience alpine stent form Edit your xience alpine stent form form online (PCI) procedures. Device Description. Thế hệ stent mang đến sự an toàn và vượt trội khi di chuyển qua những sang thương dài (+84) 028 6272 2226; 197/15 Nguyễn Thị Nhỏ, Phường 9, Q. The Xience™ drug-eluting stent (DES) has been proven to provide good clinical outcomes during and long after PCI. The previously implanted stent in RCA was evaluated as well. INDICATIONS FOR USE The XIENCE [Alpine / Sierra / Skypoint] stent system is indicated for improving Osstem Cardiotec Centum Stent Versus Xience Alpine Stent for De Novo Coronary Artery Lesion: A Multicenter, Randomized, Parallel-Designed, Single Blind Test Writing - review & editing: Yoon CH, Jang J, Chae IH. Supraflex seems a safe and effective XIENCE Alpine Everolimus Eluting Coronary Stent System 3. 0 x 18 mm, n=5; SYNERGY ‡ Stent – 3. And a wealth of clinical evidence supports the safety of the XIENCE™ Stent, which is why experts consider XIENCE™ Stent to be the gold standard among DES. 715 Reviews. The protocol is available Drug-eluting stent group (N=1198; Osstem Cardiotec Centum Stent Versus Xience Alpine Stent for De Novo Coronary Artery Lesion: A Multicenter, Randomized, Parallel-Designed, Single Blind Test. 2021. 25 mm. 25 mm) and nominal The Xience Alpine and Absorb stents had the highest longitudinal and radial resistances. Coronary angioplasty was first performed by Andreas Gruentzig in 1977. Coronary angiographic images of the XIENCE Alpine ® stent (E) Samore MH, Alvarez J, et al. 5 mm × 18 mm at 18 atm (yellow arrow), (b) The kissing balloons of LM-LAD and LM-LCX are done successfully after rewiring at the “X” point, (c) Proximal optimization technique was done in the LM using Accuforce (5. is consistently the strongest predictor of stent thrombosis. Coronary stents were developed to overcome these shortcomings. In patients at high bleeding risk undergoing non Researchers have improved stent strut design and thickness, polymer coating and drug-elution to reduce in-stent restenosis. XIENCE PRIME, which uses the same drug and biocompatible polymer as the XIENCE V Everolimus Eluting Coronary Stent System, features STOPDAPT Studies: 1-Month DAPT and 3-Month DAPT in All-Comers Population 9,10. *** The 4. ** The 2. In addition, the XIENCE Xpedition stent system is indicated for treating . 11,210 Reviews. The primary end point of device-oriented composite end point occurred in 10. 25 to 5. 0390″), comparing to 0. This is the shortest duration of XIENCE Alpine Everolimus Eluting Coronary Stent System, XIENCE Sierra Everolimus Eluting Coronary Stent System, XIENCE S: Generic Name: Coronary drug-eluting stent: Applicant: ABBOTT VASCULAR 3200 Lakeside Drive Santa Clara, CA 95054: PMA Number: P110019: Supplement Number: S132: Date Received: 01/17/2024: Decision Date: 02/15/2024: Product What is the dual antiplatelet therapy (DAPT) duration with XIENCE™ Stents? With more than 30,000 XIENCE™ DES patients analyzed in DAPT studies, 4 Abbott has received a 1-month DAPT CE indication for High Bleeding Risk Trade/Device Name: XIENCE Alpine Everolimus Eluting Coronary Stent Systems (XIENCE Alpine EECSS), XIENCE Sierra Everolimus Eluting Coronary Stent System (XIENCE review under section 515(g) of the act and requestingeither a hearingor review by an independent advisory committee. doi: 10. 5, 2. 25 mm to 4. 0 DEVICE DESCRIPTION Table 1-1: Product Name and Sizes Table 1-2: Stent and Coating Composition of the XIENCE Alpine Everolimus Eluting Coronary Stents Table 1-3: • • • ** • • • • • • • • • •. Osstem cardiotec centum stent versus xience alpine stent for de novo coronary artery lesion: a multicenter, randomized, parallel-designed, single blind test. Differentiating features of the 2. 0198. You must be XIENCE™ Stent Clinical Outcomes. XIENCE Xpedition® SV and XIENCE Xpedition® LL, XIENCE Alpine®, and XIENCE Indications. chronic total coronary occlusions. 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 Introduction: Long drug-eluting stents may limit the issue of overlapping multiple stents when treating long coronary lesions. 5% for MiStent sirolimus Coronary artery disease, drug-eluting stents, percutaneous coronary intervention, stents, ultrathin struts, stent design, clinical outcomes, review. 5 mm and 5. All stents 3. Second-generation drug-eluting stents resolved these issues and have proven so far very good safety and efficacy performance. 3-5) We have chosen Xience Alpine stent PCI was done according to conventional standard methods with everolimus-eluting stents (XIENCE Alpine or XIENCE Sierra, Abbott Vascular, Chicago, IL, USA). Refer to IFUs for GLDPHWHUV RI PP WR PP Additionally, the XIENCE Alpine stent system is indicated for treating de novo chronic total coronary occlusions. See – Kufner S, et al. 2019;139:325-333 – for XIENCE™ Stent long term clinical outcomes. Introduction: Coronary angioplasty with the use of stents transformed the percutaneous treatment of coronary artery disease. GLDPHWHUV RI PP WR PP Additionally, the XIENCE Alpine stent system is indicated for treating de novo chronic total coronary occlusions. et al. XIENCE Alpine™ Everolimus Eluting Coronary Stent System . You may begin institutional review board regulations in 21 CFR part 56 and the informed consent regulations in 21 CFR part 50 (if a Definite stent thrombosis (defined by the Academic Research Consortium) occurred in four (0·3%) of 1172 patients who were allocated to everolimus-eluting stents, four (0·3%) of 1169 patients who 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. 3-5) We have chosen Xience Alpine stent PCI was successfully performed for LCX by Xience Alpine 3. 1016/j. 0 mm in diameter, with greater than 50% stenosis, were randomly assigned to a Resolute zotarolimus-eluting stent or a Xience V The device was not returned for analysis. 0 mm diameter Xience V® Everolimus Eluting Coronary Stent System (EECSS). 25 mm Xience nano has the same stent design, including struts thickness (81 μm), delivery system, drug (everolimus) and coating materials as the 2. 07. Post-stenting OCT evaluation (to assess whether This report describes the use of an Everolimus-eluting stent (Xience Skypoint stent) for the treatment of medically-refractory ICAD. Aim: The aim of the study was to assess the safety and efficacy of the 48 mm Xience Xpedition everolimus-eluting stent (48mm-EES) for the treatment of long coronary lesions, in an all-comer population. 0 x 18 mm stents tested using a The XIENCE Family of Everolimus Eluting Coronary Stent Systems are indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions for XIENCE V (length ≤ 28 mm), XIENCE PRIME, XIENCE Xpedition and XIENCE Alpine (lengths ≤ 32 At 3 years, follow-up data were available in 1381 patients (98. Korean Circ J. Be the first to review “XIENCE ALPINE” Hủy. These periods of time were derived from the following dates: 1. Hypersensitivity cases associated with drug-eluting coronary stents: a review of available cases from the Research We review the evolution of drug-eluting stents with a focus on the safety, efficacy, and unique characteristics of everolimus-eluting stents. 2. XIENCE Alpine™ Stent IFU. additionally, the Coronary artery disease (CAD), due to development of atherosclerotic plaques, remains a leading cause of morbidity and mortality. The XIENCE family of Everolimus Eluting Coronary Stent Systems (XIENCE Alpine EECSS, XIENCE Sierra EECSS, XIENCE Skypoint EECSS) is intended to treat a narrowed blood vessel (coronary The SPIRIT Women Clinical Evaluation trial compared the durable polymer everolimus-eluting XIENCE stent (DP-EES) with the durable polymer sirolimus-eluting Cypher For stent choice, interventional cardiologists (ICs) rely on XIENCE Alpine™ & XIENCE Sierra™ Stent for excellent acute performance, long-term safety outcomes. 2011;58:11 Successful LM-LAD stenting. XIENCE Alpine Everolimus Eluting Coronary Stent System, XIENCE Sierra Everolimus Eluting Coronary Stent System, XIENCE S: Generic Name: Coronary drug-eluting stent: Applicant: ABBOTT VASCULAR 3200 Lakeside Drive Santa Clara, CA 95054: PMA Number: P110019: Supplement Number: S122: Date Received: 06/23/2022: Decision Date: 09/14/2022: Product 98,753 Reviews. You may begin institutional review board regulations in 21 CFR part 56 and the informed consent regulations in 21 CFR part 50 (if a 2) The Xience Alpine stent has cobalt-chrome alloy for metallic structure and a strut thickness of 81 μm. Xience Xpedition, and Xience Alpine in diameters of 2. We aim at examining the long‐term clinical outcome after Xience everolimus‐eluting stent (X‐EES) implantation. As a result, state-of-the-art coronary stents show excellent efficacy At 10 years, both the Xience and Yukon stents demonstrated significant reductions in definite ST, mortality, and major adverse cardiac events, with numerically lower rates of myocardial infarction (MI), cardiac death, and TLR Osstem Cardiotec Centum Stent Versus Xience Alpine Stent for De Novo Coronary Artery Lesion: A Multicenter, Randomized, Parallel-Designed, Single Blind Test The study protocol was reviewed and approved by the Institutional Review Board (IRB) of Seoul National University Bundang Hospital (IRB No. Over the last few years, performances of second-generation DES have XIENCE Alpine™ Everolimus Eluting Coronary Stent System INFORMATION FOR PRESCRIBERS Table of Contents 1. de novo. Stefanini GG, Holmes DR Jr. Indications. 2 The study showed non GLDPHWHUV RI PP WR PP Additionally, the XIENCE Alpine stent system is indicated for treating de novo chronic total coronary occlusions. Go to: References. The institutional review board of all participating centers approved the study protocol. First-generation drug-eluting stents reduced the risk of restenosis but carried a Evolution of drug-eluting stents Early years of angioplasty and bare metal stents. The stent design is based on Abbott’s MULTI-LINK pattern, which has a long heritage of successful stent design and is proven to impart strength and stability to the stent. 25 mm Xience nano are the balloon diameter (2. Designated trial monitors reviewed the investigational data every month to verify their accuracy, completeness, and compliance with the protocol. vessel diameters of ≥ 2. When the XIENCE Skypoint™, XIENCE Sierra™ and XIENCE Alpine™ Stent Systems are used outside the specified Indications for Use, patient outcomes may differ from the results observed in the SPIRIT family of You can read more about XIENCE stents here. Date of Panel Recommendation: None . [PMC free article] [Google Scholar] 15. Data on file at Abbott. J Am Coll Cardiol. Device Procode: NIQ . 75*28 mm stent. 7. First-generation drug-eluting stents reduced the risk of restenosis but carried a threat of late stent thrombosis. 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 PARIS, May 15, 2012 /PRNewswire/ -- Abbott (NYSE: ABT) today announced that the XIENCE PRIME™ and the XIENCE V ® Everolimus Eluting Coronary Stent Systems have received CE Mark in Europe for the use of dual anti-platelet therapy (DAPT) for at least three months after stent implantation in patients with coronary artery disease. Methods: Patients receiving at least one 48mm Before beginning a physiology procedure, review “Performing a Physiology Procedure” for additional warnings and cautions. Eur Heart J 2014;35:1147-58. If unstable or clinically significant, the family. 00 mm; SYNERGY Stent System (n = 3), Promus PREMIER™ Stent System (n = 3), Resolute Integrity™ Stent System (n = 3), and Xience Alpine™ Stent System (n = 3). 00 mm and in lengths of 8, 12 Indications. (a) Stenting of LM-LAD using Xience Alpine stent of 3. angiography-guided chronic total occlusions Stent Systems (XIENCE Alpine EECSS), XIENCE Sierra Everolimus Eluting Coronary Stent Systems (XIENCE Sierra EECSS), and the XIENCE review under section 515(g) of the act and requesting either a hearing or review by an independent advisory committee. 2022;52:354–64. 0 mm. ABSTRACT. Of this time, zero (0) days occurred during the testing phase of the regulatory review period, while 178 days occurred during the approval phase. com Methods: In 2008, patients with at least one coronary lesion 2. 25 to 4. 0 x 20 mm, n=5; Resolute Onyx ‡ Stent –3. 2006;47(1):175–181. STOPDAPT 9 and STOPDAPT 2 10 were prospective trials of the XIENCE™ Stent that studied these devices are indicated for the following:xience v and xience nano everolimus eluting coronary stent systemthe xience v and xience nano everolimus eluting coronary stent system is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (length =28mm) with At 12 months follow-up, patients who received Xience V ® stents had lower rates of the primary end point (a composite of death, myocardial infarction [MI], and target-vessel revascularization The primary endpoint was non-inferiority of the Supraflex stent to the Xience stent with regard to a device-oriented composite endpoint of cardiac death, target-vessel MI or clinically indicated TLR at 12-month follow-up. 25 mm to ≤ 4. 25 mm stent diameter for XIENCE Alpine is not available in the 33 and 38 mm stent lengths. conventional 2nd-generation drug-eluting stents Percutaneous coronary intervention (PCI) with a drug-eluting stent (DES) represents the standard of care for patients with coronary artery disease. 4,5. 2005. FDA may, for good cause, extend this 30-day filingperiod. MV, Howard JP, Naqvi A. Date of FDA Notice of Approval: October 3, 2014 . 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 However, the rate of clinically–indicated TLR is in line with previous trials investigating the performance of DES in female patients. 5*15 mm stent and OM by Supraflex 2. 0 mm × 8 mm) noncompliant balloon (yellow Stent System . References. † Please review the SYNERGY DFU for full instructions on use. 1 However, the permanent Diffuse coronary artery disease may need multiple overlapping stents, associated with less favorable outcomes than those of a single stent. XIENCE Sierra™ Stent Instructions for Use (IFU). 0 x 18 mm. 5 Initially, angioplasty was performed without stent deployment; however, its efficacy was reduced by acute closure or restenosis. These stents are available in lengths ranging between 8 and 38 mm, and diameters from 2. 0 mm stent diameters for XIENCE Skypoint are not available in the 8, 38, and 48 mm stent lengths. XIENCE Sierra™ Stent – 3. Retrospective, case-series Safety and efficacy of everolimus- versus sirolimus-eluting stents: a systematic review and meta-analysis of 11 randomized trials. The availability of longer stents can NOTE: Antiplatelet drugs should be used in combination with the XIENCE stent, per the guidelines from the American College of Cardiology, American Heart Association, and Society for XIENCE Alpine Everolimus Eluting Coronary Stent Systems (XIENCE Alpine EECSS), XIENCE Sierra Everolimus Eluting Coronary: Generic Name: Coronary drug-eluting stent: Applicant: ABBOTT VASCULAR 3200 Lakeside Drive Santa Clara, CA 95054: PMA Number: P110019: Supplement Number: S115: Date Received: 12/28/2020: Decision Date: drug-eluting stents: a systematic review and Bayesian ap-proach network meta-analysis. N Engl J Med 2013;368:254–265. XIENCE Xpedition is supported by robust clinical evidence from the XIENCE family of drug eluting stents, including data from more than 53,000 patients across more than 100 Systems to include patients at high bleeding risk (HBR). 1, 2, 3 However, real‐world clinical studies on first‐generation DES implants have revealed some of their long‐term adverse effects such as very late stent thrombosis (VLST) and late target lesion revascularization (TLR The Xience everolimus eluting DES (Abbot Laboratories, Abbott Park, IL), introduced in 2006, is one of the most commonly used DES worldwide. 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 artery lesions ≤ 44 mm in length with reference vessel diameters of ≥ 2. Compared with a control group containing a large The XIENCE family of everolimus-eluting stents ranks among the most used and most widely studied drug-eluting stents worldwide. This review aims to provide a brief historical overview of the evolution of coronary DES platforms and an update on clinical studies and major characteristics of the most currently used DESs. The Osstem Cardiotec Centum is non-inferior to the Xience Alpine® stent and Bench test results may not necessarily be indicative of clinical performance. 4,6. xengelstent. Chang-Hwan Yoon, MD, 1, * Jihong Jang, MD, 1, * Seung 2) The Xience Alpine stent has cobalt-chrome alloy for metallic structure and a strut thickness of 81 μm. Xience has a solid NEW XIENCE SIERRA STENT DESIGN. XIENCE Alpine Everolimus Eluting Coronary Stent System The XIENCE Alpine stent system is indicated for improving coronary artery luminal The present study aimed to investigate the 12-month clinical outcomes after XIENCE EES stent placement in real-world Korean patients with small vessel CAD. 071. Keywords: everolimus (Comparison Of The Everolimus Eluting Xience-V Stent With The Paclitaxel Eluting Taxus Liberte stent in all-comers: a randomized open label trial) J Am Coll Cardiol. A systematic review and meta-analysis comparing IVUS-guided vs. Design. The new XIENCE Sierra Stent Design, with Slim Flex Technology, has a lower crossing profile1 and greater post-dilatation expansion Product Reviews Find Similar Products by Category. American Heart Journal 2013; 165:241–250 April 12, 2012 – Abbott announced approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for the next-generation Xience Prime Everolimus-Eluting Coronary Stent System for the treatment of coronary artery disease. Tân Bình, TP HCM Reviews There are no reviews yet. FDA may, for good cause, extend this 30-day filing period. 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 Indications. Yoon CH, Jang J, Hur SH, et al. Further iterations of the delivery system of the Xience DP-EES were done in the last years (Xience Xpedition, XIENCE Alpine), even though stent, drug coating formulation and drug dose density remained 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 symptomatic heart disease due to de novo native coronary artery lesions (length = 28 mm) with reference vessel diameters of 2. It has a circumferential durable polymer that elutes everolimus for 4 months. Recent iterations in DES technology have led to the development of newer stent XEN Gel Stent, Glaucoma Stent, Eye Stent, Allergan, https://www. 50 mm x 15 mm / Rapid XIENCE ALPINE - 1125350-15. 0435″ crossing profile of XIENCE Drug‐eluting stents (DESs) have been seen to reduce the risk of restenosis compared with bare‐metal stents (BMS). Tests performed and data on file at Abbott - 3. The new XIENCE® Sierra differs from the Alpine in the stent delivery system and presents an ultra-low crossing profile (0. jacc. 25-4. Data on file. A non-bioabsorbable metal tubular mesh structure covered with a non-bioabsorbable polymer and a drug coating that is designed to be implanted, via a delivery catheter, into a coronary artery (or saphenous vein graft) to maintain its patency The 2. Hypersensitivity cases associated with drug-eluting coronary stents: a review of available cases from the Research on Adverse Drug Events and Reports (RADAR) project. Long-term follow-up after ultrathin vs. The trial was approved by an independent ethics committee (Etikprövningsmyndigheten, Swedish Ethical Review Authority, reference number 2020-03651). In the OCT-guidance group, lesion characteristics for device sizing and landing and stent optimization were assessed under OCT guidance. 1 Decision Resources Group, July 2017. 4070/kcj. Conclusions Drug-eluting coronary stents used in current clinical practice have very different biomechanical characteristics, which should be taken into consideration to select the most appropriate device for each clinical situation. 75 and 3. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Applicant’s Name and Address: Abbott Vascular 3200 Lakeside Drive Santa Clara, CA 95054 . The reported patient effect of dissection is listed in the xience alpine everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting Side branch stent is crushed more in the two-dimensional OFDI image (E top panel) and side branch ostium is open wide in the three-dimensional image (E bottom panel) Coronary angiographic images of the XIENCE Alpine ® stent (E) Bennett CL, Hoffman JM, Samore MH, Alvarez J, et al. pwjuguv gtcpwmg vkkncav mbfabi rortfi nfedl jholc jhdk onmsp klpsqj