Summary
Edwards Lifesciences Corp (Edwards) is a global medical technology company which focuses on the development, manufacture and marketing of products and technologies used for the treatment of structural heart disease and critical conditions. It develops and commercializes heart valve products such as tissue heart valves and repair products aimed for the replacement or repair of a patient's diseased or defective heart valve. Edwards also offers hemodynamic monitoring systems, which is used for the measurement of a patient's cardiovascular function in the hospital setting. Edwards sells its products through direct sales forces and a network of independent distributors. The company operates in North America, Europe, Asia-Pacific and other countries the world over. Edwards is headquartered in Irvine, California, the US.
This report is a source for data, analysis, and actionable intelligence on the company’s portfolio of pipeline products. The report provides key information about the company, its major products and brands.
The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage.
Scope:
- The report reviews detailed company profile with information on business description, key company facts, major products and services, key competitors, key employees, locations and subsidiaries and recent developments
- The report analyzes all pipeline products in development for the company Edwards Lifesciences Corp
- The report provides pipeline analysis on all pipeline products of the company (by equipment type, by indication, by development stage, and by trial status)
- The report covers detailed information on each pipeline product with information on pipeline territory, stage of development, device class, regulatory path, indication(s), application(s) and estimated launch date
- The report provides detailed description of products in development, technical specification and functions
- The report also covers ongoing clinical trials (wherever applicable) with information on trial name, trial objective, sponsor, trial design , trial status and phase, estimated start and end date.
Reasons to Buy:
- Develop business strategies by understanding the trends and developments driving the medical devices pipeline and technology landscape
- Design and develop your product development, marketing and sales strategies by understanding the competitor portfolio
- To formulate effective Research & Development strategies
- Develop market-entry and market expansion strategies
- Exploit in-licensing and out-licensing opportunities by identifying products, most likely to ensure a robust return
- Plan mergers and acquisitions effectively by identifying key players of the most promising pipeline
- Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage
- Develop competition strategies by identifying the status and likely launch of the competitors’ pipeline products through review of the clinical trials, stage and of development, etc
- Identify, understand and capitalize the next high-value products that your competitor would add in its portfolio
'
Table of Contents
Table of Contents 2
List of Tables 5
List of Figures 7
Edwards Lifesciences Corp Company Overview 8
Edwards Lifesciences Corp Company Snapshot 8
Edwards Lifesciences Corp Pipeline Products and Ongoing Clinical Trials Overview 8
Edwards Lifesciences Corp – Pipeline Analysis Overview 11
Business Description 11
Edwards Lifesciences Corp - Key Facts 11
Edwards Lifesciences Corp - Major Products and Services 12
Edwards Lifesciences Corp Pipeline Products by Development Stage 14
Edwards Lifesciences Corp Ongoing Clinical Trials by Trial Status 17
Edwards Lifesciences Corp Pipeline Products Overview 20
Acumen Hypotension Probability Indicator 20
Acumen Hypotension Probability Indicator Product Overview 20
Cardiaq Mitral Valve 21
Cardiaq Mitral Valve Product Overview 21
Cardiaq Mitral Valve Clinical Trial 22
Cardinal Adjustable Annuloplasty Ring System - Tricuspid Repair 23
Cardinal Adjustable Annuloplasty Ring System - Tricuspid Repair Product Overview 23
Cardioband System - Mitral Valve Repair 24
Cardioband System - Mitral Valve Repair Product Overview 24
Cardioband System - Mitral Valve Repair Clinical Trial 25
Cardioband System - Tricuspid Regurgitation 26
Cardioband System - Tricuspid Regurgitation Product Overview 26
Cardioband System - Tricuspid Regurgitation Clinical Trial 27
Carpentier-Edwards BioPhysio Aortic Valve 28
Carpentier-Edwards BioPhysio Aortic Valve Product Overview 28
Coapsys 29
Coapsys Product Overview 29
Edwards CENTERA Valve 30
Edwards CENTERA Valve Product Overview 30
Edwards CENTERA Valve Clinical Trial 31
Edwards SAPIEN 3 Transcatheter Heart Valve - Low Risk 32
Edwards SAPIEN 3 Transcatheter Heart Valve - Low Risk Product Overview 32
Edwards SAPIEN 3 Transcatheter Heart Valve - Low Risk Clinical Trial 33
Enhanced FloTrac Algorithm 34
Enhanced FloTrac Algorithm Product Overview 34
FORMA Tricuspid Repair System 35
FORMA Tricuspid Repair System Product Overview 35
FORMA Tricuspid Repair System Clinical Trial 36
FORTIS Mitral Transcatheter Heart Valve 37
FORTIS Mitral Transcatheter Heart Valve Product Overview 37
FORTIS Mitral Transcatheter Heart Valve Clinical Trial 38
GLX Aortic Conduit 39
GLX Aortic Conduit Product Overview 39
HemoSphere 40
HemoSphere Product Overview 40
INSPIRIS RESILIA Aortic Valve 41
INSPIRIS RESILIA Aortic Valve Product Overview 41
INSPIRIS RESILIA Aortic Valve Clinical Trial 42
Integrated Semi-Closed Loop System 43
Integrated Semi-Closed Loop System Product Overview 43
INTUITY Valve System 44
INTUITY Valve System Product Overview 44
INTUITY Valve System Clinical Trial 45
KONECT Conduit 46
KONECT Conduit Product Overview 46
Magna EASE Surgical Valve With GLX 47
Magna EASE Surgical Valve With GLX Product Overview 47
Magna EASE Surgical Valve With GLX Clinical Trial 48
MOBIUS Leaflet Repair System 49
MOBIUS Leaflet Repair System Product Overview 49
MONARC Mitral Repair System 50
MONARC Mitral Repair System Product Overview 50
Next Gen CENTERA 51
Next Gen CENTERA Product Overview 51
Next Gen SAPIEN 52
Next Gen SAPIEN Product Overview 52
Next-Gen EndoVent With Pacing 53
Next-Gen EndoVent With Pacing Product Overview 53
Next-Gen QuickDraw Cannula 54
Next-Gen QuickDraw Cannula Product Overview 54
Next-generation Hemodynamic Monitor 55
Next-generation Hemodynamic Monitor Product Overview 55
PASCAL Transcatheter Mitral Valve Repair System 56
PASCAL Transcatheter Mitral Valve Repair System Product Overview 56
PASCAL Transcatheter Mitral Valve Repair System Clinical Trial 57
Sapien 3 Heart Valve - Heart Failure 58
Sapien 3 Heart Valve - Heart Failure Product Overview 58
Sapien 3 Heart Valve - Heart Failure Clinical Trial 59
Sapien 3 Heart Valve - Mitral Annular Calcification 60
Sapien 3 Heart Valve - Mitral Annular Calcification Product Overview 60
Sapien 3 Heart Valve - Mitral Annular Calcification Clinical Trial 61
Sapien 3 Heart Valve - Pulmonic 62
Sapien 3 Heart Valve - Pulmonic Product Overview 62
Sapien 3 Ultra Delivery System 63
Sapien 3 Ultra Delivery System Product Overview 63
Sapien XT Heart Valve - Inferior Vena Cava (Tricuspid) 64
Sapien XT Heart Valve - Inferior Vena Cava (Tricuspid) Product Overview 64
Sapien XT Heart Valve - Inferior Vena Cava (Tricuspid) Clinical Trial 65
Second Generation Transapical Transcatheter Mitral Valve 66
Second Generation Transapical Transcatheter Mitral Valve Product Overview 66
Transatrial Cardioband System 67
Transatrial Cardioband System Product Overview 67
V-Chordal System - Transfemoral 68
V-Chordal System - Transfemoral Product Overview 68
V-Chordal-Off-Pump 69
V-Chordal-Off-Pump Product Overview 69
Valtech Cardiovalve 70
Valtech Cardiovalve Product Overview 70
Edwards Lifesciences Corp - Key Competitors 71
Edwards Lifesciences Corp - Key Employees 72
Edwards Lifesciences Corp - Key Employee Biographies 73
Edwards Lifesciences Corp - Locations And Subsidiaries 74
Head Office 74
Other Locations & Subsidiaries 74
Recent Developments 77
Edwards Lifesciences Corp, Recent Developments 77
Mar 09, 2017: Boston Scientific Receives Favorable Rulings In Edwards Lifesciences Litigation 77
Feb 01, 2017: Edwards Lifesciences Reports Fourth Quarter Results 77
Jan 17, 2017: Edwards Receives CE Mark For Advanced Hemodynamic Monitor Platform 79
Dec 09, 2016: Centurion Recalls Multi-Med Single Lumen Catheters due to Excess Material that May Split or Separate 79
Dec 08, 2016: Edwards Lifesciences Outlines Growth Strategy At Annual Investor Conference 80
Nov 01, 2016: Early And Sustained Quality Of Life Improvements Seen For Intermediate Risk Patients Treated With Edwards Transcatheter Valves 81
Nov 01, 2016: Patients with Severe Aortic Stenosis and Intermediate Surgical Risk Show Similar Late Quality of Life Outcomes Following Either Transcatheter or Surgical Aortic Valve replacement 82
Nov 01, 2016: Edwards Sapien Valves Demonstrate Excellent Durability In 5-Year Echo Study 82
Oct 31, 2016: EDWARDS INTUITY Elite Rapid Deployment Valve Approved In Canada 83
Oct 25, 2016: Edwards Lifesciences Reports Third Quarter Results 83
Appendix 85
Methodology 85
About GlobalData 87
Contact Us 87
Disclaimer 87
List of Tables
Edwards Lifesciences Corp Pipeline Products and Ongoing Clinical Trials Overview 8
Edwards Lifesciences Corp Pipeline Products by Equipment Type 9
Edwards Lifesciences Corp Pipeline Products by Indication 10
Edwards Lifesciences Corp Ongoing Clinical Trials by Trial Status 10
Edwards Lifesciences Corp, Key Facts 11
Edwards Lifesciences Corp, Major Products and Services 12
Edwards Lifesciences Corp Number of Pipeline Products by Development Stage 14
Edwards Lifesciences Corp Pipeline Products Summary by Development Stage 15
Edwards Lifesciences Corp Ongoing Clinical Trials by Trial Status 17
Edwards Lifesciences Corp Ongoing Clinical Trials Summary 18
Acumen Hypotension Probability Indicator - Product Status 20
Acumen Hypotension Probability Indicator - Product Description 20
Cardiaq Mitral Valve - Product Status 21
Cardiaq Mitral Valve - Product Description 21
Cardiaq Mitral Valve - Early Feasibility Study of the CardiAQ Transcatheter Mitral Valve Implantation (TMVI) System (Transfemoral and Transapical Delivery Systems) For the Treatment of Moderate to Severe Mitral Regurgitation 22
Cardiaq Mitral Valve - Reduction or elimination of Mitral Regurgitation in Degenerative or Functional Mitral Regurgitation with the CardiAQ-Edwards Transcatheter Mitral Valve: The RELIEF Trial 22
Cardinal Adjustable Annuloplasty Ring System - Tricuspid Repair - Product Status 23
Cardinal Adjustable Annuloplasty Ring System - Tricuspid Repair - Product Description 23
Cardioband System - Mitral Valve Repair - Product Status 24
Cardioband System - Mitral Valve Repair - Product Description 24
Cardioband System - Mitral Valve Repair - Annular Contraction for Transcatheter Treatment of Insufficient Mitral Valve (ACTIVE): A Multicenter, Randomized, Controlled Pivotal Trial to Assess Transcatheter Mitral Valve Repair with Cardioband and Guideline Directed Medical Therapy (GDMT) Compared to GDMT Alone in Patients with Functional Mitral Regurgitation (FMR) and Heart Failure 25
Cardioband System - Mitral Valve Repair - Cardioband Adjustable Annuloplasty System for Minimally Invasive Mitral Valve Repair 25
Cardioband System - Mitral Valve Repair - Transcatheter Repair of Mitral Insufficiency with Cardioband System - REPAIR 25
Cardioband System - Tricuspid Regurgitation - Product Status 26
Cardioband System - Tricuspid Regurgitation - Product Description 26
Cardioband System - Tricuspid Regurgitation - Randomized Controlled Pilot Study Comparing Healing with Epidermal Fractional Blistergrafting (Cellutome) to Acellular Technique (Membrane or Cream Dressings) in Superficial to Mid-dermal Burn Wounds 27
Carpentier-Edwards BioPhysio Aortic Valve - Product Status 28
Carpentier-Edwards BioPhysio Aortic Valve - Product Description 28
Coapsys - Product Status 29
Coapsys - Product Description 29
Edwards CENTERA Valve - Product Status 30
Edwards CENTERA Valve - Product Description 30
Edwards CENTERA Valve - Safety and Performance Study of the Edwards Centera Self-expanding Transcatheter Heart Valve 31
Edwards CENTERA Valve - Safety and Performance Study of the Edwards CENTERA-EU Self-expanding Transcatheter Heart Valve 31
Edwards SAPIEN 3 Transcatheter Heart Valve - Low Risk - Product Status 32
Edwards SAPIEN 3 Transcatheter Heart Valve - Low Risk - Product Description 32
Edwards SAPIEN 3 Transcatheter Heart Valve - Low Risk - A Prospective, Randomized, Controlled, Multi-center Study to Establish the Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients Who Have Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement 33
Enhanced FloTrac Algorithm - Product Status 34
Enhanced FloTrac Algorithm - Product Description 34
FORMA Tricuspid Repair System - Product Status 35
FORMA Tricuspid Repair System - Product Description 35
FORMA Tricuspid Repair System - Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System 36
FORMA Tricuspid Repair System - The SPACER Trial - Repair of Tricuspid Valve Regurgitation Using the Edwards Tricuspid Transcatheter Repair System 36
FORTIS Mitral Transcatheter Heart Valve - Product Status 37
FORTIS Mitral Transcatheter Heart Valve - Product Description 37
FORTIS Mitral Transcatheter Heart Valve - Early Feasibility Study of the CardiAQ Transcatheter Mitral Valve Implantation (TMVI) System (Transfemoral and Transapical Delivery Systems) For the Treatment of Moderate to Severe Mitral Regurgitation 38
GLX Aortic Conduit - Product Status 39
GLX Aortic Conduit - Product Description 39
HemoSphere - Product Status 40
HemoSphere - Product Description 40
INSPIRIS RESILIA Aortic Valve - Product Status 41
INSPIRIS RESILIA Aortic Valve - Product Description 41
INSPIRIS RESILIA Aortic Valve - Prospective, Non-randomized, Multicenter Clinical Evaluation of the Edwards Pericardial Aortic and Mitral Bioprostheses (Models 11000a and 11000m) with a New Tissue Treatment Platform (COMMENCE) 42
Integrated Semi-Closed Loop System - Product Status 43
Integrated Semi-Closed Loop System - Product Description 43
INTUITY Valve System - Product Status 44
INTUITY Valve System - Product Description 44
INTUITY Valve System - A Randomized Comparison of the EDWARDS INTUITY Valve System and Commercially Available Aortic Bioprostheses in Subjects Undergoing Surgical Aortic Valve Replacement 45
INTUITY Valve System - Multi-center Experience with the Rapid Deployment Edwards INTUITY Valve System for Aortic Valve Replacement 45
INTUITY Valve System - Surgical Treatment of Aortic Stenosis with a Next Generation Surgical Aortic Valve 45
KONECT Conduit - Product Status 46
KONECT Conduit - Product Description 46
Magna EASE Surgical Valve With GLX - Product Status 47
Magna EASE Surgical Valve With GLX - Product Description 47
Magna EASE Surgical Valve With GLX - Clinical Study to Evaluate the Performance of Magna Ease Heart Valve in Chinese Patients 48
Magna EASE Surgical Valve With GLX - Edwards Receives IDE for U.S. Clinical Trial of New Heart Valve Tissue Treatment Platform 48
MOBIUS Leaflet Repair System - Product Status 49
MOBIUS Leaflet Repair System - Product Description 49
MONARC Mitral Repair System - Product Status 50
MONARC Mitral Repair System - Product Description 50
Next Gen CENTERA - Product Status 51
Next Gen CENTERA - Product Description 51
Next Gen SAPIEN - Product Status 52
Next Gen SAPIEN - Product Description 52
Next-Gen EndoVent With Pacing - Product Status 53
Next-Gen EndoVent With Pacing - Product Description 53
Next-Gen QuickDraw Cannula - Product Status 54
Next-Gen QuickDraw Cannula - Product Description 54
Next-generation Hemodynamic Monitor - Product Status 55
Next-generation Hemodynamic Monitor - Product Description 55
PASCAL Transcatheter Mitral Valve Repair System - Product Status 56
PASCAL Transcatheter Mitral Valve Repair System - Product Description 56
PASCAL Transcatheter Mitral Valve Repair System - CE Mark Study of PASCAL Transcatheter Mitral Valve Repair System 57
Sapien 3 Heart Valve - Heart Failure - Product Status 58
Sapien 3 Heart Valve - Heart Failure - Product Description 58
Sapien 3 Heart Valve - Heart Failure - Transcatheter Aortic Valve Replacement to Unload the Left Ventricle in Patients with Advanced Heart Failure: A Randomized Trial (TAVR UNLOAD) 59
Sapien 3 Heart Valve - Mitral Annular Calcification - Product Status 60
Sapien 3 Heart Valve - Mitral Annular Calcification - Product Description 60
Sapien 3 Heart Valve - Mitral Annular Calcification - Surgical Implantation of Transcatheter valve in Native Mitral Annular Calcification (SITRAL) Study 61
Sapien 3 Heart Valve - Mitral Annular Calcification - The Safety and Feasibility of the SAPIEN XT Transcatheter Heart Valve with NovaFlex and Ascendra Delivery Systems and SAPIEN 3 with Commander Delivery System in Patients with Symptomatic Severe Calcific Mitral Valve Disease with Severe Mitral Annular Calcification and Patients with Failing Mitral Surgical Rings or Bioprostheses Who Are Not Candidates for Mitral Valve Surgery. 61
Sapien 3 Heart Valve - Pulmonic - Product Status 62
Sapien 3 Heart Valve - Pulmonic - Product Description 62
Sapien 3 Ultra Delivery System - Product Status 63
Sapien 3 Ultra Delivery System - Product Description 63
Sapien XT Heart Valve - Inferior Vena Cava (Tricuspid) - Product Status 64
Sapien XT Heart Valve - Inferior Vena Cava (Tricuspid) - Product Description 64
Sapien XT Heart Valve - Inferior Vena Cava (Tricuspid) - Treatment of Severe Secondary Tricuspid Regurgitation in Patients with Advance Heart Failure with Caval Vein Implantation of the Edwards Sapien XT Valve 65
Second Generation Transapical Transcatheter Mitral Valve - Product Status 66
Second Generation Transapical Transcatheter Mitral Valve - Product Description 66
Transatrial Cardioband System - Product Status 67
Transatrial Cardioband System - Product Description 67
V-Chordal System - Transfemoral - Product Status 68
V-Chordal System - Transfemoral - Product Description 68
V-Chordal-Off-Pump - Product Status 69
V-Chordal-Off-Pump - Product Description 69
Valtech Cardiovalve - Product Status 70
Valtech Cardiovalve - Product Description 70
Edwards Lifesciences Corp, Key Employees 72
Edwards Lifesciences Corp, Key Employee Biographies 73
Edwards Lifesciences Corp, Other Locations 74
Edwards Lifesciences Corp, Subsidiaries 74
Glossary 86
List of Figures
Edwards Lifesciences Corp Pipeline Products by Equipment Type 9
Edwards Lifesciences Corp Pipeline Products by Development Stage 14
Edwards Lifesciences Corp Ongoing Clinical Trials by Trial Status 17
