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  • News bot Oct. 30, 2025, 8:31 p.m.

    📋 Edwards Lifesciences Corp (EW) - Clinical Trial Update

    Filing Date: 2025-10-30

    Accepted: 2025-10-30 16:29:32

    Event Type: Clinical Trial Update

    Event Details:

    Edwards Lifesciences Corp (EW) Announces Clinical Trial Update Edwards Lifesciences Corp (EW) provided an update on its clinical development programs. Clinical Development Highlights:
    • Drug Program: continue
    • Diseases/Conditions: an advisory role
    • Collaboration: CA USA
    • Updated Timeline: Oct. 30, 2025

    🔬 Clinical Development Pipeline (Edwards Lifesciences Corp):

    Product Type Development Stage Therapeutic Area Source
    Mitral Valve Repair DEVICE Approved Mitral Valve Regurgitation ClinicalTrials.gov
    J-Valve Transfemoral (TF) System DEVICE Approved Aortic Valve Regurgitation ClinicalTrials.gov
    MITRIS RESILIA Mitral Valve, Model 11400M DEVICE Preclinical Mitral Stenosis ClinicalTrials.gov
    INNOVALVE system DEVICE Approved Mitral Valve Regurgitation (Degenerative or Functional) ClinicalTrials.gov
    The HemoSphere advanced monitoring platform with Acumen HPI software, and Acumen IQ sensor and Acumen IQ cuff DEVICE Approved Moderate to High-risk Noncardiac Surgery ClinicalTrials.gov
    Acumen HPI Smart Alerts and Smart Trends Software DEVICE Approved Moderate to High-risk Noncardiac Surgery ClinicalTrials.gov
    SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA DEVICE Approved Aortic Stenosis, Calcific ClinicalTrials.gov
    HemoSphere Vita Monitor, VitaWave or VitaWave Plus Finger Cuff Adult, ForeSight Large Sensors DEVICE Approved Blood Pressure ClinicalTrials.gov
    Transcatheter Tricuspid Valve Repair DEVICE Approved Tricuspid Regurgitation ClinicalTrials.gov
    Optimal Medical Therapy DRUG Approved Tricuspid Valve Regurgitation ClinicalTrials.gov
    Edwards EVOQUE System DEVICE Approved Tricuspid Valve Regurgitation ClinicalTrials.gov
    TAVI PROCEDURE Approved Aortic Valve Stenosis ClinicalTrials.gov
    Edwards PASCAL Transcatheter Valve Repair System DEVICE Approved Tricuspid Regurgitation ClinicalTrials.gov
    Edwards Alterra Adaptive Prestent with SAPIEN 3 THV DEVICE Approved Pulmonary Disease ClinicalTrials.gov
    Edwards PASCAL System DEVICE Approved Tricuspid Regurgitation ClinicalTrials.gov
    - Non-Invasive Near-infrared Spectroscopy (NIRS) device (HEM1 with Foresight Elite Sensor) DEVICE Preclinical Subarachnoid Hemorrhage, Aneurysmal ClinicalTrials.gov
    Transcatheter Atrial Shunt System DEVICE Approved Heart Failure ClinicalTrials.gov
    Inspectra TM/O-To-See TM (Tissue oxymetry with near infrared spectroscopy and laser-Doppler) DEVICE Approved Cardiac Output, High ClinicalTrials.gov
    Volume challenge / Change of vasoactive drugs or inotropics OTHER Approved Cardiac Output, High ClinicalTrials.gov
    Passive leg raising OTHER Approved Cardiac Output, High ClinicalTrials.gov
    Vigileo TM / Flotrac TM (Minimally invasive cardiac output system consisting of arterial line sensor and cardiac output monitor) DEVICE Approved Cardiac Output, High ClinicalTrials.gov
    Aortic valve replacement by bioprosthesis PROCEDURE Approved Aortic Valve Replacement ClinicalTrials.gov
    3 dimensional echocardiography PROCEDURE Approved Mitral Valve Regurgitation ClinicalTrials.gov
    minimally invasive cardiac output system consisting of arterial line sensor and cardiac output bedside monitor (device) DEVICE Preclinical Cardiac Output, High ClinicalTrials.gov
    Intravenous Blood Glucose monitoring system DEVICE Preclinical Blood Glucose ClinicalTrials.gov
    FloTrac Sensor DEVICE Phase PHASE4 Esophageal Diseases ClinicalTrials.gov
    Vigileo Monitor DEVICE Phase PHASE4 Esophageal Diseases ClinicalTrials.gov
    Prophylaxis of Thrombosis after aortic valve replacement PROCEDURE Preclinical Aortic Valve Disease ClinicalTrials.gov
    FloTrac™ and EV1000™ DEVICE Approved Critical Illness ClinicalTrials.gov
    CardiAQ TMVI System (Transapical DS) DEVICE Approved Mitral Insufficiency ClinicalTrials.gov
    GlucoClear System DEVICE Preclinical Intensive Care Unit Blood Glucose Monitoring ClinicalTrials.gov
    V Chordal DEVICE Phase PHASE2 Mitral Leaflet Prolapse ClinicalTrials.gov
    carbetocin DRUG Phase PHASE4 Effect of Carbetocin on Cardiovascular System ClinicalTrials.gov
    CardiAQ TMVI System (Transapical & Transfemoral DS) DEVICE Approved Mitral Insufficiency ClinicalTrials.gov
    Perimount 2900/6900 Heart Valve DEVICE Preclinical Mitral Valve or Aortic Valve Replacement ClinicalTrials.gov
    Stented aortic bioprostheses DEVICE Approved Aortic Valve Disease ClinicalTrials.gov
    EDWARDS INTUITY DEVICE Approved Aortic Valve Disease ClinicalTrials.gov
    Nexfin measuremtents DEVICE Preclinical Aortic Stenosis, Calcific ClinicalTrials.gov
    Transcatheter Mitral Valve Re-placement (TMVR) with the CardiAQ-Edwards™ Transcatheter Mitral Valve DEVICE Phase PHASE1 Mitral Valve Regurgitation ClinicalTrials.gov
    pulmonary artery catheter DEVICE Preclinical Thoracic Surgery ClinicalTrials.gov
    Standard of care OTHER Approved Metabolic Stress Hyperglycemia ClinicalTrials.gov
    Intravascular continuous monitoring DEVICE Approved Metabolic Stress Hyperglycemia ClinicalTrials.gov
    Procedure/Surgery: Invasive angiography PROCEDURE Approved Severe Aortic Stenosis ClinicalTrials.gov
    Selective invasive angiography based on CT/CCTA imaging. PROCEDURE Approved Severe Aortic Stenosis ClinicalTrials.gov
    TAVR Implantation with SAPIEN DEVICE Approved Severe ClinicalTrials.gov
    TAVR Implantation with SAPIEN XT DEVICE Approved Severe ClinicalTrials.gov
    Edwards Sapien XT Valve DEVICE Phase PHASE2 Severe Tricuspid Regurgitation ClinicalTrials.gov
    Aspirin DRUG Phase PHASE4 Aortic Valve Disease ClinicalTrials.gov
    Aspirin (80 mg/d) + clopidogrel (75 mg/d) DRUG Phase PHASE4 Aortic Valve Disease ClinicalTrials.gov
    medical management and/or balloon aortic valvuloplasty OTHER Approved Critical Aortic Stenosis ClinicalTrials.gov
    Surgical Valve Replacement DEVICE Approved Critical Aortic Stenosis ClinicalTrials.gov
    Edwards SAPIEN Transcatheter Heart Valve DEVICE Approved Critical Aortic Stenosis ClinicalTrials.gov
    SAPIEN XT NovaFlex delivery system DEVICE Approved Aortic Valve Stenosis ClinicalTrials.gov
    Implantation of CEP Magna Ease Model 3300TFX DEVICE Approved Coronary Artery Disease ClinicalTrials.gov
    Harpoon Artificial ePTFE Chords DEVICE Approved Mitral Valve Regurgitation ClinicalTrials.gov
    TAVR Implantation of the Transcatheter Aortic Valve Prosthesis DEVICE Preclinical Severe Aortic Stenosis ClinicalTrials.gov
    EDWARDS INTUITY Valve System, Model 8300A DEVICE Approved Aortic Valve Disease ClinicalTrials.gov
    ClearSight™ / EV1000NI Clinical Platform DEVICE Preclinical Sepsis ClinicalTrials.gov
    transcatheter valve implantation PROCEDURE Preclinical Aortic Valve Stenosis ClinicalTrials.gov
    ClearSight feasibility testing DEVICE Preclinical Intraoperative Hypotension ClinicalTrials.gov
    EV1000NI Clinical Platform: Noninvasive Hemodynamic Monitoring utilizing ClearSight System DEVICE Preclinical Patient With Clinically Indicated Invasive Monitoring ClinicalTrials.gov
    Transcatheter aortic valve implantation DEVICE Approved Aortic Valve Stenosis ClinicalTrials.gov
    SAPIEN Transcatheter Valve Implantation DEVICE Approved Pulmonary Valve Insufficiency ClinicalTrials.gov
    Edwards CENTERA Self-Expanding Transcatheter Heart Valve DEVICE Approved Aortic Valve Disease ClinicalTrials.gov
    Transcatheter Pulmonic Valve Replacement (TPVR) (Edwards SAPIEN™ THV) DEVICE Preclinical Pulmonary Regurgitation ClinicalTrials.gov
    Edwards SAPIEN 3 Transcatheter Heart Valve DEVICE Approved Aortic Valve Disease ClinicalTrials.gov
    Implantation of CEP Magna Mitral Model 7000TFX DEVICE Approved Mitral Heart Valve Disease ClinicalTrials.gov
    Hemodynamic monitoring DEVICE Preclinical Coronary Artery Bypass Graft ClinicalTrials.gov
    Heart Valve Surgery PROCEDURE Approved Aortic Valve Disorder ClinicalTrials.gov
    Stroke volume monitoring DEVICE Approved Redo Hip Surgery ClinicalTrials.gov
    Noninvasive hemodynamic monitoring PROCEDURE Preclinical Colorectal Surgery ClinicalTrials.gov
    Standard perioperative care PROCEDURE Preclinical Colorectal Surgery ClinicalTrials.gov
    ERAS perioperative care PROCEDURE Preclinical Colorectal Surgery ClinicalTrials.gov
    Cardioband DEVICE Approved Mitral Valve Insufficiency ClinicalTrials.gov
    Cardioband Tricuspid DEVICE Approved Tricuspid Valve Insufficiency ClinicalTrials.gov
    Carpentier-Edwards PERIMOUNT Magna-Ease DEVICE Preclinical Aortic Valve Stenosis ClinicalTrials.gov
    INSPIRIS RESILIA DEVICE Preclinical Aortic Valve Stenosis ClinicalTrials.gov
    SAPIEN XT DEVICE Preclinical Aortic Valve Stenosis ClinicalTrials.gov
    SAPIEN 3 DEVICE Preclinical Aortic Valve Stenosis ClinicalTrials.gov
    AVR and CABG PROCEDURE Preclinical Aortic Valve Stenosis ClinicalTrials.gov
    TAVR Implantation of the THV Prosthesis DEVICE Approved Symptomatic Severe Aortic Stenosis ClinicalTrials.gov
    Biosensors OTHER Preclinical Hemodynamics ClinicalTrials.gov
    Sapien XT™ transcatheter heart valve and delivery system DEVICE Approved Aortic Valve Stenosis ClinicalTrials.gov
    SAPIEN S3 valve DEVICE Approved Aortic Stenosis ClinicalTrials.gov
    Daily Activity Recording BEHAVIORAL Approved Aortic Valve Stenosis ClinicalTrials.gov
    Resistance Exercises BEHAVIORAL Approved Aortic Valve Stenosis ClinicalTrials.gov
    Daily Activity Goal BEHAVIORAL Approved Aortic Valve Stenosis ClinicalTrials.gov
    SAPIEN XT™ Transapical aortic valve replacement DEVICE Approved Aortic Valve Stenosis ClinicalTrials.gov
    Edwards SAPIEN XT transcatheter valve, Model 9300TFX DEVICE Approved Aortic Stenosis ClinicalTrials.gov
    TF TAVI DEVICE Preclinical Aortic Stenosis ClinicalTrials.gov
    TAVI (Transcatheter Aortic Valve Implantation) DEVICE Preclinical Aortic Stenosis ClinicalTrials.gov
    Hypotension Prediction Index DEVICE Preclinical Surgery--Complications ClinicalTrials.gov
    Coordinator OTHER Preclinical Aortic Valve Stenosis ClinicalTrials.gov
    No Hemodynamic Monitored Guided Assesment DEVICE Preclinical Hemodynamic Monitoring ClinicalTrials.gov
    invasive Hemodynamic monitoring via Clearsight/Nexfin Systems from Edwards Lifesciences DEVICE Preclinical Hemodynamic Monitoring ClinicalTrials.gov
    MM OTHER Preclinical Aortic Valve Stenosis ClinicalTrials.gov
    SAVR PROCEDURE Preclinical Aortic Valve Stenosis ClinicalTrials.gov
    Device: Adjustable Annuloplasty Ring (with option to adjust off-pump) DEVICE Approved Mitral Valve Insufficiency ClinicalTrials.gov
    Adjustable Annuloplasty Ring with option to adjust off pump. DEVICE Approved Mitral Valve Insufficiency ClinicalTrials.gov
    Physician Notification Letter BEHAVIORAL Approved Aortic Stenosis ClinicalTrials.gov
    EDWARDS INTUITY valve DEVICE Approved Aortic Valve Stenosis ClinicalTrials.gov
    Edwards Cardioband System DEVICE Preclinical Mitral Regurgitation ClinicalTrials.gov
    Edwards FORMA Tricuspid Transcatheter Repair System DEVICE Approved Tricuspid Valve Regurgitation ClinicalTrials.gov
    Aortic Valve Replacement with EDWARDS INTUITY Valve System DEVICE Approved Aortic Valve Stenosis With Insufficiency ClinicalTrials.gov
    AVITA--Aortic Valve Improved Treatment Approaches BEHAVIORAL Preclinical Aortic Stenosis Symptomatic ClinicalTrials.gov
    HPI guided treatment advice OTHER Approved Intraoperative Hypotension ClinicalTrials.gov
    EW Tricuspid Transcatheter Repair System DEVICE Approved Tricuspid Valve Regurgitation ClinicalTrials.gov
    Hemosphere platform® together with the FloTrac® sensor DEVICE Approved Intraoperative Hypotension ClinicalTrials.gov
    Hemosphere platform® together with the FloTrac Acumen IQ® sensor DEVICE Approved Intraoperative Hypotension ClinicalTrials.gov
    SAPIEN XT THV with the NovaFlex+ delivery system DEVICE Approved Aortic Stenosis ClinicalTrials.gov
    Mitral surgery alone OTHER Approved Cardiac Surgery ClinicalTrials.gov
    Tricuspid valve repair PROCEDURE Approved Cardiac Surgery ClinicalTrials.gov
    Treatment of hypotension following standard of care DEVICE Approved Hypotension During Surgery ClinicalTrials.gov
    HPI (using HemoSphere) - guided algorithm DEVICE Approved Hypotension During Surgery ClinicalTrials.gov
    JUMPSTART exercise program BEHAVIORAL Preclinical Aortic Valve Stenosis ClinicalTrials.gov
    INSPIRIS Resilia (model 11500A) DEVICE Preclinical Heart Valve Prosthesis ClinicalTrials.gov
    Transcatheter aortic valve replacement PROCEDURE Approved Aortic Valve Stenosis ClinicalTrials.gov
    Harpoon Medical Device DEVICE Approved Mitral Valve Regurgitation ClinicalTrials.gov
    Guideline Directed Medical Therapy DRUG Approved Functional Mitral Regurgitation ClinicalTrials.gov
    Edwards SAPIEN 3/SAPIEN 3 Ultra THV DEVICE Approved Aortic Stenosis ClinicalTrials.gov
    Edwards Pericardial Aortic Bioprosthesis Model 11000A DEVICE Approved Pulmonary Valve Insufficiency ClinicalTrials.gov
    HARPOON Beating Heart Mitral Valve Repair System (MVRS) DEVICE Approved Mitral Regurgitation ClinicalTrials.gov
    Non-protocolized Standard of Care OTHER Approved Moderate to High-risk Noncardiac Surgery ClinicalTrials.gov
    AcumenTM HPI Software Feature DEVICE Approved Moderate to High-risk Noncardiac Surgery ClinicalTrials.gov
    SAVR Implantation DEVICE Approved Symptomatic Severe Aortic Stenosis ClinicalTrials.gov
    No intervention OTHER Preclinical Surgery-Complications ClinicalTrials.gov
    HPI based hemodynamic optimization algorithm OTHER Approved Hypotension ClinicalTrials.gov
    Edwards SAPIEN 3 / SAPIEN 3 Ultra THV DEVICE Approved Heart Diseases ClinicalTrials.gov
    Edwards EWJ-202 Transcatheter Tricuspid Valve Replacement System DEVICE Approved Tricuspid Valve Regurgitation ClinicalTrials.gov
    SAPIEN 3 Transcatheter Heart Valve DEVICE Preclinical Aortic Stenosis, Severe ClinicalTrials.gov
    Edwards Alterra Adaptive Prestent with SAPIEN 3 Transcatheter Pulmonary Valve System DEVICE Preclinical Pulmonary Valve Insufficiency ClinicalTrials.gov
    Edwards SAPIEN 3 transcatheter valve, Model 9600TFX DEVICE Approved Mitral Valve Insufficiency ClinicalTrials.gov
    GDT-based hemodynamic management based on Clearsight device DEVICE Approved Intraoperative Hypotension ClinicalTrials.gov
    SAPIEN M3 valve and dock DEVICE Approved Mitral Regurgitation ClinicalTrials.gov
    SAPIEN 3 Ultra RESILIA THV DEVICE Approved Complex Congenital Heart Defect ClinicalTrials.gov
    SAPIEN 3 THV DEVICE Approved Complex Congenital Heart Defect ClinicalTrials.gov
    SAPIEN 3/SAPIEN 3 Ultra RESILIA THV DEVICE Approved Complex Congenital Heart Defect ClinicalTrials.gov
    SAPIEN 3 Ultra System DEVICE Preclinical Aortic Valve Stenosis ClinicalTrials.gov
    The ABC Bicuspid Sizing Algorithm OTHER Preclinical Aortic Stenosis ClinicalTrials.gov
    AVR with or without CABG DEVICE Preclinical Aortic Valve Stenosis ClinicalTrials.gov
    SAPIEN X4 THV DEVICE Approved Aortic Stenosis, Severe ClinicalTrials.gov
    Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000M DEVICE Approved Aortic Stenosis ClinicalTrials.gov
    Transcatheter Aortic Valve Replacement (TAVR) DEVICE Preclinical Aortic Valve Stenosis ClinicalTrials.gov
    SAPIEN 3 Ultra Delivery System with the SAPIEN 3 Ultra THV DEVICE Approved Aortic Valve Stenosis ClinicalTrials.gov
    Innovalve MR system DEVICE Approved Mitral Valve Regurgitation (Degenerative or Functional) ClinicalTrials.gov
    Edwards PASCAL Transcatheter Valve Repair System and Edwards PASCAL Precision Transcatheter Valve Repair System DEVICE Preclinical Mitral Regurgitation ClinicalTrials.gov
    Edwards APTURE transcatheter shunt system DEVICE Approved Heart Failure ClinicalTrials.gov
    Edwards SAPIEN M3 System DEVICE Approved Mitral Regurgitation ClinicalTrials.gov
    ClearSight baby cuff DEVICE Preclinical Blood Pressure ClinicalTrials.gov
    SAPIEN XT THV DEVICE Preclinical Pulmonary Valve Insufficiency ClinicalTrials.gov
    EVOQUE OTHER Preclinical Tricuspid Regurgitation ClinicalTrials.gov
    CEP MAGNA MITRAL PERICARDIAL BIOPROSTHESES DEVICE Approved Coronary Artery Disease ClinicalTrials.gov
    Transcatheter Tricuspid Valve Replacement DEVICE Approved Tricuspid Valve Regurgitation ClinicalTrials.gov
    Atrial Shunt DEVICE Approved Heart Failure ClinicalTrials.gov
    Redo Mitral valve surgery PROCEDURE Approved Mitral Prosthetic Valve Stenosis and Regurgitation ClinicalTrials.gov
    Transcatheter Valve-in-Valve Intervention PROCEDURE Approved Mitral Prosthetic Valve Stenosis and Regurgitation ClinicalTrials.gov
    Transcatheter Aortic Valve Implantation (TAVI) DEVICE Approved Aortic Stenosis ClinicalTrials.gov
    Edwards INSPIRIS RESILIA Aortic Valve DEVICE Preclinical Aortic Valve Disease ClinicalTrials.gov
    APTURE transcatheter shunt DEVICE Approved Heart Failure ClinicalTrials.gov
    INSPIRIS RESILIA Aortic Valve™ DEVICE Preclinical Cardiovascular Diseases ClinicalTrials.gov
    Abbott Mitraclip System DEVICE Approved Degenerative Mitral Valve Disease ClinicalTrials.gov
    HemoSphere Advanced Monitoring Platform with Acumen IQ sensor and Tissue Oximetry Monitoring DEVICE Approved Blood Pressure ClinicalTrials.gov
    HemoSphere Alta Monitor, Swan-Ganz IQ pulmonary arterial catheter, ForeSight IQ Large sensor, and Acumen IQ sensor DEVICE Preclinical Hemodynamic Instability ClinicalTrials.gov
    TAVR with CENTERA THV DEVICE Approved Aortic Valve Stenosis ClinicalTrials.gov
    HARPOON™ Beating Heart Mitral Valve Repair System DEVICE Approved Mitral Regurgitation ClinicalTrials.gov
    Early discharge protocol BEHAVIORAL Preclinical Mitral Regurgitation ClinicalTrials.gov
    Hemosphere Advanced Monitoring System, ClearSight 1.5, Swan-Ganz Catheter, Flotrac, Foresight DEVICE Preclinical Pediatric ALL ClinicalTrials.gov
    EV1000A Clinical Platform with Acumen Hypotension Prediction Index Feature Software DEVICE Preclinical Hypotension ClinicalTrials.gov
    Virtual Reality assisted information OTHER Approved Severe Aortic Valve Stenosis ClinicalTrials.gov
    Edwards PASCAL Precision Transcatheter Valve Repair System DEVICE Preclinical Tricuspid Valve Insufficiency ClinicalTrials.gov
    Innovalve TMVR system DEVICE Approved Mitral Valve Regurgitation (Degenerative or Functional) ClinicalTrials.gov
    MITRIS RESILIA Mitral Valve DEVICE Preclinical Mitral Valve Replacement ClinicalTrials.gov
    Mitral Valve Replacement (MVR) with Sapien3 DEVICE Approved Mitral Annular Calcification ClinicalTrials.gov
    Education on tailored Quality Improvement measures OTHER Preclinical Transcatheter Aortic Valve Implantation (TAVI) ClinicalTrials.gov
    Edwards EVOQUE Eos Mitral Valve Replacement System DEVICE Approved Mitral Valve Regurgitation (Degenerative or Functional) ClinicalTrials.gov
    EV1000 Clinical Platform with Assisted Fluid Management (AFM) Feature DEVICE Approved Non-Cardiac/ Non-Thoracic Surgery ClinicalTrials.gov
    Streamlining of the pre-procedural patient pathway OTHER Preclinical Transcatheter Aortic Valve Implantation (TAVI) ClinicalTrials.gov
    Hypotension probability index (HPI) DEVICE Approved Hypotension ClinicalTrials.gov
    AcumenTM Hypotension Prediction Index software DEVICE Preclinical Hemodynamic Monitoring ClinicalTrials.gov
    TAVR DEVICE Approved Symptomatic Severe Aortic Stenosis ClinicalTrials.gov
    Elective redo transcatheter aortic valve implantation (redo-TAVI) PROCEDURE Preclinical Structural Valve Deterioration ClinicalTrials.gov
    SAPIEN 3 THV with the Commander delivery system DEVICE Approved Aortic Stenosis ClinicalTrials.gov
    Magna Ease DEVICE Preclinical Mitral Valve or Aortic Valve Replacement ClinicalTrials.gov

    💼 Business Developments:

    • Partnership
    • Acquisition: Not available
    • Licensing: Not available
    • Regulatory Approval: Not available
    • Executive Changes: Not available

    Structured Data:

    • Company Name: Edwards Lifesciences Corp
    • CIK: 0001099800
    • Ticker Symbol: EW
    • Period End Date: 2025-10-30
    • Document Type: 8-K

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