Edwards Lifesciences Medical Device Company Intelligence Report

SUMMARY

Headquartered in Irvine, California, USA, Edwards Lifesciences designs, develops, manufactures and markets a comprehensive line of products and technologies to treat advanced cardiovascular disease. The company is principally focused on heart valve therapy, critical care, cardiac surgery systems and vascular products.

Edwards claims to be the overall global leader in heart valve therapy, as well as the world leader in tissue valves and repair. The company claims its Perimount valve is the most widely-prescribed tissue heart valve in the world. The latest-generation Perimount valves, Magna and Theon, feature Edwards' new ThermaFix process which is designed to significantly reduce leaflet calcification, one of the primary causes of tissue valve deterioration. Edwards is also currently developing technologies for the percutaneous (catheter-based) repair and replacement of heart valves which can address a greater number of patients than are currently treated with conventional open-heart surgery. Edwards has three percutaneous valve programmes under way and, in March 2005, the first patient was treated in a new US clinical trial of the company's Cribier-Edwards aortic heart valve implanted without open-heart surgery.

In critical care, Edwards offers haemodynamic monitoring systems, disposable pressure transducers and central venous access products for fluid and drug delivery. The company believes the latest addition to its monitoring range, the recently launched FloTrac sensor which works with the company's Vigileo monitor, could become one of the most important developments in critical care monitoring since the Edwards Swan-Ganz pulmonary artery catheter, which it claims is considered the gold standard of haemodynamic monitoring.

This report provides a complete review of the company's activities, from its origins to its latest corporate activity, including mergers and acquisitions, agreements, divestitures, major purchasing contracts and litigation. Sections are included on products

TABLE OF CONTENTS

• OVERVIEW
• CORPORATE HISTORY
• FOUNDATION
• RECENT CORPORATE NEWS
• MERGERS AND ACQUISITIONS
• ev3's Percutaneous Mitral Valve Repair Programme
• Percutaneous Valve Technologies (PVT)
• Whitland Research
• EMBOL-X Embolic Management System
• Jomed's Mitral Valve Repair System
• Japan-based Cardiovascular Joint Venture
• CardioFocus' Surgical Business for Treating Cardiac Arrhythmias
• Research Medical
• Intramed Laboratories
• MINORITY INVESTMENTS
• Vascular Architects
• Foundation Medical Partners
• PLC Systems
• WorldHeart
• DIVESTITURES
• Japanese Cardiopulmonary Business and Pacemaker Distribution Business
• Italian Perfusion Services Business
• German Perfusion Services Unit
• Edwards Lifesciences Cardiovascular Resources
• Bentley Product Line
• Novacor Left Ventricular Assist Business
• AGREEMENTS
• 3F Therapeutics
• PLC Systems
• Crucell N.V.
• Endologix
• Carbomedics
• WorldHeart
• Cook Biotech
• Orbus Medical (OrbusNeich) and Syntheon
• INDUSTRY CONSORTIUMS
• Global Healthcare Exchange
• LITIGATION
• St Jude Medical
• PhotoMedex
• Medtronic, Cook and Gore
• CORPORATE STRUCTURE
• Heart Valve Therapy
• Cardiac Surgery Systems
• Perfusion
• Critical Care
• Vascular
• Other Distributed Products
• STRATEGIC FOCUS
• Heart Valve Therapy
• BioPhysio Heart Valve
• Percutaneous Heart Valve Technologies
• Haemodynamic Monitoring
• Minimally-Invasive Cardiac Output (MICO)
• Peripheral Stent Platform
• Financial Goals
• PRODUCTS
• HEART VALVE THERAPY
• Pericardial Heart Valves
• Perimount Magna with ThermaFix Process
• Perimount Theon Mitral System
• Perimount Aortic Heart Valve
• Perimount Mitral Heart Valve
• Other Tissue Valves
• Porcine Bioprostheses, Aortic and Mitral
• Duraflex Low Pressure Porcine Mitral Bioprosthesis
• Carpentier-Edwards S.A.V. Aortic Porcine Bioprosthesis
• Edwards Prima Plus Stentless Bioprosthesis
• Carpentier-Edwards Bioprosthetic Valved Conduit
• Mechanical Valves
• Starr-Edwards Silastic Ball Valve
• Edwards MIRA Mechanical Valve
• Heart Valve Repair
• GeoForm Annuloplasty Ring
• IMR-ETlogix Annuloplasty Ring
• MC3 Tricuspid Annuloplasty System
• Carpentier-Edwards Classic Annuloplasty Ring
• Carpentier-Edwards Physio Annuloplasty Ring
• Cosgrove-Edwards Annuloplasty System
• Heart Valve Accessories
• CARDIAC SURGERY SYSTEMS
• Embolic Management
• EMBOL-X Slim Protection System
• US Models - EMBOL-X Slim Protection System
• CO2 Laser Revascularisation
• CO2 TMR Heart Laser 2 System
• Cannulae
• Edwards Research Medical Aortic Perfusion Cannulae
• Edwards Research Medical Femoral Cannulae
• Fem-Flex and Fem-Flex II
• Edwards Research Medical Paediatric Cannulae
• Edwards Research Medical Retrograde Cardioplegia Cannulae
• Edwards Research Medical Venous Return Cannulae
• Edwards AViD Vacuum Assist Venous Return Cannulae
• Edwards Research Medical Specialty Cannulae
• Cannulae Accessories
• Edwards Research Medical Antegrade Aortic Root Catheters
• Edwards Research Medical Blood Management and Monitoring
• Vent Catheters
• AnastaFLO Intravascular Shunt
• VisuFlo Surgical Site Visualization Wand
• Monitoring
• Cardioplegia Accessories and Sets
• CRITICAL CARE PRODUCTS
• Minimally-Invasive Monitoring
• FloTrac Sensor
• Vigileo Monitor
• PreSep Central Venous Oximetry Catheter
• Swan-Ganz Catheters
• Edwards Swan-Ganz Intermittent Bolus TD Catheters
• Edwards VIP Catheter and VIP+ Catheter
• Edwards CO-Set+ Closed Injectate Delivery System
• Edwards Swan-Ganz Continuous Haemodynamic Monitoring
• Edwards CCO Catheter
• Edwards CCOmbo Catheter
• Edwards CCOmbo Volumetrics Catheter
• Vigilance Monitor
• Edwards Swan-Ganz Cath Lab Applications
• Swan-Ganz Cath Lab Catheters (Non-Thermodilution)
• Swan-Ganz Oximetry Catheters
• Swan-Ganz Volumetric Catheters
• Swan-Ganz Femoral Vein Insertion Catheters
• Swan-Ganz Monitoring Catheters
• Swan-Ganz Pulmonary Angiography Catheters
• Swan-Ganz Pacing Catheters
• Swan-Ganz Paceport Catheters
• Swan-Ganz Pacing TD Catheters
• Central Venous Access
• Vantex Antimicrobial Central Venous Catheter
• Multi-Med Central Venous Catheter
• Edwards AVA High Flow Device
• Edwards AVA 3Xi Device
• IntroFlex Introducer
• Pressure Monitoring
• TruWave Disposable Pressure Transducer
• VAMP Closed Blood Sampling System
• VAMP Plus System
• VASCULAR PRODUCTS
• LifeStent Peripheral Stents
• LifeStent NT Self-Expanding Biliary Stent
• RESILIENT Study
• LifeStent SDS Peripheral Stent System
• LifeStent LP SDS Peripheral Stent System
• LifeStent XL SDS Peripheral Stent System
• Lifespan Reinforced Expanded ePTFE Vascular Grafts
• Clot Management
• Thrombex PMT (Percutaneous Mechanical Thrombectomy) System
• Fogarty Arterial Embolectomy Catheter
• Fogarty Adherent Clot Catheter
• Fogarty Graft Thrombectomy Catheter
• Fogarty Thru-Lumen Embolectomy Catheter
• Fogarty Irrigation Catheter
• Fogarty Venous Thrombectomy Catheters
• Edwards' Latex Free Embolectomy Catheters
• Fogarty Irrigation Catheters
• Atraumatic Occlusion Products
• Fogarty Disposable Spring Clips and Handleless Clamps
• Edwards EverClip Spring Clip
• Atraumatic Inserts for Fogarty-Hydragrip Surgical Clamps
• EverGrip Insert Sets
• Fogarty Occlusion Catheters
• Carotid Shunts
• Cardiovascular Catheters
• General Surgery Products
• Edwards Cholangiography Catheters
• Edwards Laparoscopic Cholangiography Catheter
• Edwards Cholangiography Kits
• Biliary Balloon Probes
• Haemofiltration
• Aquarius Haemofiltration Machine
• BM25 Machine
• Catheters
• Hemo-Cath Silicone Catheter (double lumen side by side)
• DL Catheter (double lumen side by side)
• TRI-FLOW Catheter (triple lumen)
• DFXL 400 Catheter (high flow)
• PSHF Haemofilters
• Aquamax Haemofilters/Haemodiafilters
• Flexible Silicone Catheter
• Microplas MPS Plasma Filter
• Visualisation
• Edwards Fogarty Valvulotome
• Edwards Intramed Irrigation Pump and Accessories
• Edwards Intramed Single Use Angioscopes
• Edwards Side Branch Occlusion System
• Perfusion Products
• Oxygenators
• Edwards Vital Adult Membrane Oxygenator
• INTERNATIONAL ACTIVITIES
• JAPAN
• CARIBBEAN
• Puerto Rico
• Dominican Republic
• LATIN AMERICA
• Brazil
• EUROPE
• Switzerland
• GLOBAL LOCATIONS
• RESEARCH AND DEVELOPMENT
• RESEARCH ESTABLISHMENTS
• RESEARCH PROJECTS
• Heart Valve Therapy Projects
• Percutaneous Heart Valve Programme
• Coronary Sinus Repair
• Edge-to-Edge Repair
• Percutaneous Aortic Heart Valve
• BioPhysio Aortic Valve
• RESEARCH AGREEMENTS
• PLC Systems
• Sangamo BioSciences
• Sangamo - Development Agreement Terms
• FINANCIAL REVIEW
• FINANCIAL INDICATORS
• FINANCIAL HIGHLIGHTS
• COMMENTARY
• Operating Divisions
• Revenue by Operating Segment, 2003-2004 (US$ million)
• Global Review
• Revenue by Country of Destination, 2003-2004 (US$ million)
• Long-lived Tangible Assets by Geographic Location, 2003-2004 (US$ million)
• FIRST QUARTER OF FISCAL 2005
• OUTLOOK

INDEX OF TABLES

• FINANCIAL INDICATORS
• Revenue by Operating Segment, 2003-2004 (US$ million)
• Revenue by Country of Destination, 2003-2004 (US$ million)
• Long-lived Tangible Assets by Geographic Location, 2003-2004 (US$ million)

INDEX OF CHARTS

• Fig.1: Percentage of Revenue by Operating Segment, 2004
• Fig.2: Percentage of Revenue by Operating Segment, 2000
• Fig.3: Percentage of Revenue by Operating Segment, 2005*
• Fig.4: Percentage of Revenue by Country of Destination, 2004
• Fig.5: Revenue by Destination, 1998-2004 (US$ million)