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Edwards Lifesciences Corp (EW)

Edwards Lifesciences Corporation is a global medical technology firm specializing in sophisticated products and technologies for structural heart conditions, alongside critical care and surgical patient monitoring. With operations spanning the United States, Europe, Japan, and various international territories, the company offers a comprehensive suite of solutions. Their structural heart disease portfolio encompasses transcatheter heart valve replacement systems designed for minimally invasive procedures, as well as transcatheter repair and replacement options specifically targeting mitral and tricuspid valve pathologies, exemplified by their PASCAL and Cardioband systems. Additionally, they provide advanced surgical structural heart solutions, including the INSPIRIS aortic surgical valve, the KONECT RESILIA pre-assembled aortic tissue valved conduit for complex valve, root, and ascending aorta replacements, and the HARPOON Beating Heart Mitral Valve Repair System for patients suffering from degenerative mitral regurgitation. In the realm of critical care, Edwards supplies advanced hemodynamic monitoring systems that assess patients' cardiac function and fluid status in both surgical and intensive care environments. This offering also features the Acumen Hypotension Prediction Index software, which provides early alerts to clinicians regarding potential dangerously low blood pressure. The company distributes its products to healthcare providers through a combination of its proprietary sales force and independent distributor networks. Founded in 1958, Edwards Lifesciences Corporation maintains its headquarters in Irvine, California.

Sector: Orthopedic, Prosthetic & Surgical Appliances & Supplies

Industry: Medical - Devices

Edwards Lifesciences Corporation logo

Edwards Lifesciences Corporation

NYSE:EWHealthcare
-2.57%$92.01
AH$92.01+0.00%vs close
Mkt Cap$53.03B
Float571.02M
O/S576.4M
Vol
$ Vol
RVOL
Inst Own89.8%
SI1.6%
Earnings
Dilution
Edwards Lifesciences Corporation logoNYSE:EW$92.01-2.57%
Phase Distribution
128 lead-sponsored trials·42 active·64 completed
Phase 1/21
Phase 21
Not applicable126
(78 more as collaborator)
Status Overview
Not yet recruiting3
Recruiting15
Active, not recruiting27
Completed64
Stopped16
Unknown3

Trials need funding. See this company's dilution risk and cash position.

Clinical Trials
Sponsor role
Status
Phase
  • Phase 2
    Terminated

    V-Chordal Adjustable System for Chordal Replacement in Mitral Valve Insufficiency Due to Leaflet Prolapse

    V Chordal

    Mitral Leaflet Prolapse

    Enrollment
    5
    Start
    Nov 2010
    Primary Completion
    May 2012
    Completion
    Mar 2013
    NCT01415947
  • Phase 1/2
    Withdrawn

    CardiAQ-Edwards™ Transcatheter Mitral Valve Replacement (TMVR) Study

    Transcatheter Mitral Valve Re-placement (TMVR) with the CardiAQ-Edwards™ Transcatheter Mitral Valve

    Mitral Valve Regurgitation

    Enrollment
    0
    Start
    Nov 2016
    Primary Completion
    Oct 2019est.
    Completion
    Oct 2024est.
    NCT02722551
  • Observational
    Completed

    Using Minimally Invasive Cardiac Output Data vs. Standard Care for Patients Emergently Admitted to the Intensive Care Unit Who Are Hemodynamically Unstable

    minimally invasive cardiac output system consisting of arterial line sensor and cardiac output bedside monitor (device)

    Cardiac Output, High, Cardiac Output, Low

    Enrollment
    392
    Start
    Jul 2006
    Primary Completion
    Sep 2007
    Completion
    Dec 2007
    NCT00354211
  • Not applicable
    Completed

    THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial

    Edwards SAPIEN Transcatheter Heart Valve, Surgical Valve Replacement

    Critical Aortic Stenosis

    Enrollment
    1,057
    Start
    Apr 2007
    Primary Completion
    Sep 2010
    Completion
    Jul 2017
    NCT00530894
  • Not applicable
    Completed

    COMPASSION - COngenital Multicenter Trial of Pulmonic VAlve Regurgitation Studying the SAPIEN InterventIONal THV

    SAPIEN Transcatheter Valve Implantation

    Pulmonary Valve Insufficiency, Pulmonary Regurgitation +3

    Enrollment
    81
    Start
    Apr 2008
    Primary Completion
    Nov 2015
    Completion
    Dec 2019
    NCT00676689
  • Not applicable
    Completed

    PREVAIL-TF: Transfemoral Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Europe)

    Sapien XT™ transcatheter heart valve and delivery system

    Aortic Valve Stenosis

    Enrollment
    214
    Start
    Dec 2008
    Primary Completion
    Dec 2010
    Completion
    Mar 2016
    NCT00820599
  • Not applicable
    Completed

    Magna® Mitral Pericardial Bioprostheses Post-Approval Study Protocol

    CEP MAGNA MITRAL PERICARDIAL BIOPROSTHESES

    Coronary Artery Disease, Mitral Valve Regurgitation +2

    Enrollment
    329
    Start
    Aug 2007
    Primary Completion
    Mar 2024
    Completion
    Mar 2024
    NCT00853632
  • Observational
    Completed

    Clinical Study of the Intravenous Blood Glucose System in Hospitalized Adult Elective or Non-Emergent Surgery and Medical/Surgical Intensive Care Unit Patients

    Intravenous Blood Glucose monitoring system

    Blood Glucose

    Enrollment
    100
    Start
    Jun 2009
    Primary Completion
    Apr 2010
    Completion
    May 2010
    NCT00906490
  • Not applicable
    Completed

    PREVAIL-J - Transfemoral & Transapical Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Japan)

    Transcatheter aortic valve implantation

    Aortic Valve Stenosis

    Enrollment
    64
    Start
    Apr 2010
    Primary Completion
    Oct 2011
    Completion
    May 2016
    NCT01113983
  • Not applicable
    Completed

    CARDINAL Adjustable Annuloplasty Ring System For Treatment of Mitral Regurgitation

    Adjustable Annuloplasty Ring with option to adjust off pump., Device: Adjustable Annuloplasty Ring (with option to adjust off-pump)

    Mitral Valve Insufficiency

    Enrollment
    30
    Start
    Mar 2010
    Primary Completion
    Feb 2012
    Completion
    Jan 2014
    NCT01137734
  • Not applicable
    Completed

    Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprosthesis, Model 3300TFX

    Implantation of CEP Magna Ease Model 3300TFX

    Coronary Artery Disease, Aortic Valve Disorder +3

    Enrollment
    283
    Start
    Oct 2007
    Primary Completion
    Sep 2018
    Completion
    Sep 2018
    NCT01171625
  • Observational
    Completed

    SOURCE XT REGISTRY

    TAVR Implantation of the Transcatheter Aortic Valve Prosthesis, TAVR Implantation of the Transcatheter Aortic Valve Prosthesis

    Severe Aortic Stenosis

    Enrollment
    2,954
    Start
    Sep 2010
    Primary Completion
    Aug 2014
    Completion
    Nov 2016
    NCT01238497
  • Not applicable
    Completed

    PREVAIL-TA: Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Europe)

    SAPIEN XT™ Transapical aortic valve replacement

    Aortic Valve Stenosis

    Enrollment
    220
    Start
    Sep 2009
    Primary Completion
    Feb 2011
    Completion
    Mar 2016
    NCT01238835
  • Not applicable
    Completed

    Magna Mitral - 23mm

    Implantation of CEP Magna Mitral Model 7000TFX

    Mitral Heart Valve Disease

    Enrollment
    39
    Start
    Mar 2011
    Primary Completion
    Nov 2018
    Completion
    Nov 2018
    NCT01312779
  • Not applicable
    Completed

    PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High Risk

    TAVR Implantation with SAPIEN XT, SAVR Implantation

    Symptomatic Severe Aortic Stenosis

    Enrollment
    2,032
    Start
    Mar 2011
    Primary Completion
    Jan 2016
    Completion
    Jan 2024
    NCT01314313
  • Observational
    Completed

    Pulmonic Valve REplacement Multi-discIpline EMEA Registry

    Transcatheter Pulmonic Valve Replacement (TPVR) (Edwards SAPIEN™ THV)

    Pulmonary Regurgitation, Pulmonary Insufficiency +1

    Enrollment
    127
    Start
    Jan 2011
    Primary Completion
    Jul 2013
    Completion
    Dec 2017
    NCT01356108
  • Observational
    Completed

    Clinical Evaluation of a New Transpulmonary Thermodilution Method to Assess Thermodilution Cardiac Output, Global End Diastolic Volume and Extravascular Lung Water

    -

    Cardiac Output and Preload Assessment, Lung Water Assessment

    Enrollment
    97
    Start
    Jan 2010
    Primary Completion
    Dec 2010
    Completion
    Dec 2010
    NCT01405040
  • Not applicable
    Completed

    PREVAIL-20J - Transfemoral Placement of 20mm Aortic Balloon Expandable Transcatheter Valve Trial

    SAPIEN XT NovaFlex delivery system

    Aortic Valve Stenosis

    Enrollment
    17
    Start
    Jun 2011
    Primary Completion
    Jan 2013
    Completion
    Dec 2017
    NCT01419015
  • Not applicable
    Completed

    Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve

    Aortic Valve Replacement with EDWARDS INTUITY Valve System

    Aortic Valve Stenosis With Insufficiency, Aortic Valve Stenosis

    Enrollment
    295
    Start
    Jan 2010
    Primary Completion
    Dec 2017
    Completion
    Dec 2017
    NCT01445171
  • Observational
    Completed

    MITRAFIT- Cardinal Adjustable Mitral Repair Follow-up International Postmarketing Surveillance (PMS)

    -

    Mitral Regurgitation

    Enrollment
    45
    Start
    May 2012
    Primary Completion
    Jun 2016
    Completion
    Jun 2016
    NCT01617720
  • Not applicable
    Completed

    Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000

    Heart Valve Surgery

    Aortic Valve Disorder, Aortic Valve Insufficiency +3

    Enrollment
    133
    Start
    Jul 2011
    Primary Completion
    Jul 2018
    Completion
    Jul 2018
    NCT01651052
  • Not applicable
    Completed

    The SOLACE-AU Clinical Trial

    TAVR Implantation of the Transcatheter Aortic Valve Prosthesis

    Severe, Symptomatic Aortic Stenosis

    Enrollment
    199
    Start
    Apr 2012
    Primary Completion
    Feb 2016
    Completion
    Aug 2018
    NCT01675596
  • Not applicable
    Completed

    Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve

    EDWARDS INTUITY valve

    Aortic Valve Stenosis, Aortic Valve Stenosis With Insufficiency +2

    Enrollment
    934
    Start
    Sep 2012
    Primary Completion
    May 2021
    Completion
    May 2021
    NCT01700439
  • Not applicable
    Completed

    ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of Edwards Pericardial Bioprostheses With a New Tissue Treatment Platform (COMMENCE)

    Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000M

    Aortic Stenosis, Mitral Stenosis +3

    Enrollment
    777
    Start
    Dec 2012
    Primary Completion
    Aug 2017
    Completion
    Mar 2026
    NCT01757665
  • Not applicable
    Completed

    Safety and Performance Study of the Edwards CENTERA Self-Expanding Transcatheter Heart Valve

    Edwards CENTERA Self-Expanding Transcatheter Heart Valve

    Aortic Valve Disease

    Enrollment
    34
    Start
    Feb 2013
    Primary Completion
    Sep 2013
    Completion
    Aug 2018
    NCT01808274

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