Edwards Lifesciences Corporation Product Pipeline Analysis

SUMMARY

Edwards Lifesciences Corporation Product Pipeline Analysis

Summary

This report is an insightful source for data, analysis and strategic insights into a Edwards Lifesciences Corporation's pipeline and investigational products. The report also provides details on clinical trials covering trial phase, description, investigator information, primary and secondary end-points and trial results for products in development.

Scope

• Details of development stage by sector and equipment type.
• Pipeline products grouped by therapy area, development stage and trial phase.
• Detailed information on clinical trials covering trial phase, description, investigator .nformation, primary and secondary end-points and trial results.
• Trial updates, trial start and end dates, patient numbers and the trials primary outcome measures, secondary outcome measures.
• Product updates covering estimated approval dates and estimated launch dates.
• Descriptions of novel technologies relating to pipeline products of the company.
• Patents and patent applications covered for the product.
• News updates on key events relating to the product and its development.

Reasons to buy

• A single source to fulfill competitor information relating to products in development.
• Identify pipeline products that are potential competitor to your product lines.
Understand a company's strategic position by accessing detailed independent intelligence on its product pipeline.
• Access clinical trial information to map trial results and plan targeted marketing activities.
• Take corrective measures on your own development programs and R&D initiatives based on regulatory events of competitor product pipelines.
• Identification of potential investment opportunities.
• Build up knowledge base for potential distribution and marketing partners.
• Helps avoid patent infringement.
• Timelines from concept to market lets you keep track of market potential build for a new product.
Assess a company's future growth by determining its pipeline depth, for probable acquisition opportunities.

TABLE OF CONTENTS

1 Table of Contents 3
1.1 List of Tables 9
1.2 List of Figures 10
2 Company Snapshot 11
2.1 Key Information 11
2.2 Company Overview 11
2.3 Financial Performance 11
2.4 Industry Outlook -- Cardiovascular Devices 11
3 Business Description 12
3.1 Business Overview 12
3.2 Cardiac Surgery Systems Product 12
3.2.1 Overview 12
3.2.2 Financials 12
3.2.3 Key Strategies 12
3.3 Critical Care Product 12
3.3.1 Overview 12
3.3.2 Financials 13
3.4 Heart Valve Therapy Product 13
3.4.1 Overview 13
3.4.2 Financials 13
3.4.3 Market View 13
3.4.4 Key Strategies 13
3.5 Other Distributed Products 13
3.5.1 Overview 13
3.5.2 Financials 13
3.6 Vascular Product 14
3.6.1 Overview 14
3.6.2 Financials 14
3.6.3 Key Strategies 14
3.7 Major Products and Services 14
3.7.1 Overview 14
4 History 16
5 Business Strategy 17
5.1 Mission Statement 17
5.2 Strategy 17
5.3 Corporate Social Responsibility 17
5.3.1 Overview 17
6 Value Chain Analysis 18
6.1 Manufacturing 18
6.1.1 In House Manufacturing 18
6.2 Product Development 19
6.2.1 Regulatory Approvals 19
6.2.2 Clinical Trials 19
6.2.3 Research and Development 20
6.3 Sales and Marketing 20
6.3.1 Partnerships and Alliances 20
6.3.2 Licensing Agreements 20
7 Competitors 21
8 Share Holding Structure 22
9 Key Employees 23
10 Key Employee Biographies 24
11 Company Statement 25
12 Locations And Subsidiaries 28
12.1 Head Office 28
12.2 Other Locations & Subsidiaries 28
13 Recent Developments 30
13.1 Strategy And Business Planning 30
13.1.1 May 22, 2008: Edwards Lifesciences Opens New Singapore Heart Valve Facility 30
13.2 Financial Announcements 30
13.2.1 Jul 22, 2008: Edwards Lifesciences Reports 2Q 2008 Results 30
13.2.2 May 27, 2008: Edwards Lifesciences Spent $0.16 Million Lobbying In Q1 2008 31
13.2.3 Apr 22, 2008: Edwards Lifesciences Provides Financial Guidance For 2008 32
13.2.4 Apr 22, 2008: Edwards Lifesciences Reports Q1 2008 Results 32
13.2.5 Feb 05, 2008: Edwards Lifesciences Reports Q4 2007 Results 33
13.2.6 Oct 22, 2007: Edwards Lifesciences Declares Q3 2007 Results 35
13.2.7 Jul 23, 2007: Edwards Lifesciences Reports Q2 2007 Results 36
13.2.8 Apr 23, 2007: Edwards Lifesciences Reports Q1 2007 Results 37
13.2.9 Feb 05, 2007: Edwards Lifesciences Reports Q4 2006 Results 38
13.2.10 Oct 19, 2006: Edwards Lifesciences Reports Q3 2006 Results 39
13.2.11 Jul 24, 2006: Edwards Lifesciences Reports Q2 2006 Results 40
13.2.12 May 11, 2006: Edwards Lifesciences Announces Approval of New Stock Repurchase 40
13.2.13 Apr 20, 2006: Edwards Lifesciences Reports Q1 2006 Results 41
13.2.14 Feb 02, 2006: Edwards Lifesciences Reports Q4 2005 Results 41
13.3 Corporate Communications 42
13.3.1 Apr 16, 2008: Edwards Lifesciences Director Retires 42
13.3.2 Feb 18, 2008: Edwards Lifesciences Announces Organizational Changes 42
13.3.3 Mar 23, 2007: Edwards Lifesciences Appoints New Corporate Officers 43
13.3.4 Feb 16, 2006: Edwards Lifesciences Elects New Member To The Board 44
13.4 Legal and Regulatory 44
13.4.1 Mar 21, 2008: Cook Wins Patent Infringement Suit With Edwards 44
13.4.2 Feb 12, 2008: Edwards Lifesciences Files Lawsuit Against CoreValve 44
13.4.3 May 10, 2007: Edwards Lifesciences Initiates Litigation Against CoreValve 44
13.4.4 Jan 23, 2006: Edwards Lifesciences and Medtronic Settles Infringement Lawsuit 45
13.5 Product News 45
13.5.1 May 12, 2008: Edwards Lifesciences Introduces New Transcatheter Valve Delivery System At EuroPCR 2008 45
13.5.2 Apr 18, 2008: Edwards Lifesciences Announces First Implants In US Study Of Minimally-Invasive Pulmonic Valve 46
13.5.3 Jan 29, 2008: Edwards Lifesciences Receives FDA Approval To Add Transapical Delivery System To US Clinical Trial Of Transcatheter Heart Valve 46
13.5.4 Jan 29, 2008: Edwards Lifesciences Receives FDA Approval To Add Transapical Delivery System To US Clinical Trial Of Transcatheter Heart Valve 47
13.5.5 Jan 04, 2008: Edwards SAPIEN Transcatheter Heart Valve Training Program Launches In Europe 47
13.5.6 Dec 06, 2007: Edwards Lifesciences Receives European Approval For First Minimally Invasive Surgical Valve Replacement System 47
13.5.7 Oct 23, 2007: Edwards Lifesciences: US may delay approval of new valves 48
13.5.8 Oct 23, 2007: Edwards Lifesciences: US may delay approval of new valves 48
13.5.9 Sep 13, 2007: Edwards Lifesciences Announces First Live Implant Of New BioPhysio Heart Valve 48
13.5.10 Sep 05, 2007: Edwards Lifesciences Receives CE Mark For Edwards SAPIEN Transcatheter Heart Valve 48
13.5.11 Aug 29, 2007: Edwards Lifesciences Introduces First Real-Time, Continuous Central Venous Oxygenation Saturation Monitoring Technology For Critically Ill Children 49
13.5.12 Oct 20, 2006: TCT Program Includes Clinical Presentations Featuring Edwards' Interventional Cardiovascular Technologies 49
13.5.13 Sep 22, 2005: Edwards Launches New Mitral Magna Heart Valve in Europe 49
13.5.14 Nov 18, 2003: FDA Approves Edwards Lifesciences' PERIMOUNT Magna Tissue Heart Valve 50
13.5.15 Oct 16, 2003: New Data Demonstrate Enhanced Durability for Edwards' PERIMOUNT Mitral Valve 50
13.6 Product Approvals 50
13.6.1 Jan 29, 2008: Edwards Lifesciences Receives FDA Approval To Add Transapical Delivery System To US Clinical Trial Of Transcatheter Heart Valve 50
13.6.2 Dec 06, 2007: Edwards Lifesciences Receives European Approval For First Minimally Invasive Surgical Valve Replacement System 51
13.6.3 Sep 05, 2007: Edwards Lifesciences Receives CE Mark For Edwards SAPIEN Transcatheter Heart Valve 51
13.6.4 Nov 18, 2003: FDA Approves Edwards Lifesciences' PERIMOUNT Magna Tissue Heart Valve 51
13.7 Clinical Trials 52
13.7.1 Apr 18, 2008: Edwards Lifesciences Announces First Implants In US Study Of Minimally-Invasive Pulmonic Valve 52
13.7.2 Jan 29, 2008: Edwards Lifesciences Receives FDA Approval To Add Transapical Delivery System To US Clinical Trial Of Transcatheter Heart Valve 52
13.7.3 Sep 13, 2007: Edwards Lifesciences Announces First Live Implant Of New BioPhysio Heart Valve 53
13.7.4 Oct 20, 2006: TCT Program Includes Clinical Presentations Featuring Edwards' Interventional Cardiovascular Technologies 53
13.7.5 Oct 16, 2003: New Data Demonstrate Enhanced Durability for Edwards' PERIMOUNT Mitral Valve 54
14 Edwards Lifesciences Corporation Pipeline Products 55
14.1 Edwards Lifesciences Corporation Product Pipeline Analysis 55
14.1.1 Edwards Lifesciences Corporation Pipeline Products By Equipment Type 55
14.1.2 Edwards Lifesciences Corporation Pipeline Products By Development Stage 57
14.1.3 Edwards Lifesciences Corporation Pipeline Products By Therapy Area 58
14.1.4 Edwards Lifesciences Corporation Pipeline Products By Clinical Trials 58
14.1.5 Edwards Lifesciences Corporation Pipeline Products By News Summary 59
14.2 MONARC Mitral Repair System 60
14.2.1 Product Description 60
14.2.2 Product Status 60
14.2.3 Clinical Trials 61
14.3 MOBIUS Leaflet Repair System 62
14.3.1 Product Description 62
14.3.2 Product Status 62
14.3.3 Clinical Trials 63
14.3.4 Product Milestone 63
14.4 Edwards SAPIEN Transcatheter Heart Valve 64
14.4.1 Product Description 64
14.4.2 Product Status 64
14.4.3 Clinical Trials 65
14.4.4 Product Milestone 67
14.5 PERIMOUNT Magna Ease Aortic Valve 67
14.5.1 Product Description 67
14.5.2 Product Status 68
14.5.3 Product Milestone 68
14.6 PERIMOUNT Magna Heart Valve 69
14.6.1 Product Description 69
14.6.2 Product Status 69
14.6.3 Product Milestone 69
14.7 BioPhysio valve 70
14.7.1 Product Description 70
14.7.2 Product Status 70
14.7.3 Clinical Trials 70
14.7.4 Product Milestone 70
14.8 Ascendra Transapical Delivery System 71
14.8.1 Product Description 71
14.8.2 Product Status 71
14.8.3 Clinical Trials 72
14.8.4 Product Milestone 74
14.9 Physio II Mitral Repair System 75
14.9.1 Product Description 75
14.9.2 Product Status 75
14.10 PERIMOUNT Magna Aortic Heart Valve 75
14.10.1 Product Description 75
14.10.2 Product Status 75
14.10.3 Product Milestone 76
15 Appendix 77
15.1 Methodology 77
15.1.1 Coverage 77
15.1.2 Secondary Research 78
15.1.3 Primary Research 78
15.1.4 Expert Panel Validation 79
15.2 Contact Us 79
15.3 About Global Markets Direct 79
15.4 Disclaimer 79

1.1 List of Tables
Table 1: Edwards Lifesciences Corporation,Key Facts, 2007 11
Table 2: Edwards Lifesciences Corporation, Share Holding Structure 22
Table 3: Edwards Lifesciences Corporation, Key Employees, 2007 23
Table 4: Edwards Lifesciences Corporation, Other Locations 28
Table 5: Edwards Lifesciences Corporation, Subsidiaries 29
Table 6: Edwards Lifesciences Corporation Pipeline Products by Equipment Type 56
Table 7: Edwards Lifesciences Corporation Pipeline Products By Development Stage 57
Table 8: Edwards Lifesciences Corporation Pipeline Products By Therapy Area 58
Table 9: Edwards Lifesciences Corporation Pipeline Products By Clinical Trials 58
Table 10: Edwards Lifesciences Corporation Pipeline Products By News Summaries 60

1.2 List of Figures
Figure 1: Edwards Lifesciences Corporation, Value Chain Analysis 18
Figure 2: Edwards Lifesciences Corporation Pipeline Products By Equipment Type 55
Figure 3: Edwards Lifesciences Corporation Pipeline Products By Equipment Type 56
Figure 4: Edwards Lifesciences Corporation Pipeline Products By Development Stage 57
Figure 5: Edwards Lifesciences Corporation Pipeline Products By News Summary 59
Figure 6: Global Markets Direct Methodology 77