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Abbott Laboratories
AGA Medical Corporation
Arrow International Inc.
ArteriA Medical Science Inc.
Bacchus Vascular Inc.
Boston Scientific Corporation
Datascope Corporation
Guidant Corporation
Johnson & Johnson
Kensey Nash Corporation
Medtronic Inc.
Micro Therapeutics, Inc.
Microvena Corporation/EndiCOR Medical Inc.
NMT Medical Inc.
Possis Medical Inc.
Rubicon Medical Corporation
Scion Cardio-Vascular Inc.
Spectranetics Corporation
St. Jude Medical Inc.
Vascular Solutions Inc.
EXECUTIVE SUMMARY
Arterial Closure
Debulking Technologies
Embolic Protection
Mechanical Thrombectomy
Defect Closure
Emerging Technologies
Companies
Summary Exhibit 1: U.S. Adjunctive Coronary Transcatheter Market by Major Category, 2000-2006
Summary Exhibit 2: U.S. Market for Arterial Closure Devices, 2000-2006
Summary Exhibit 3: U.S. Market for Debulking Products, 2000-2006
Summary Exhibit 4: U.S. Market for Embolic Protection Devices, 2000-2006
Summary Exhibit 5: U.S. Market for Mechanical Thrombectomy Devices, 2000-2006
Summary Exhibit 6: U.S. Market for Transcatheter Defect Closure Devices, 2000-2006
1.0 OVERVIEW OF CARDIOVASCULAR DISORDERS
1.1 Components and Function
1.1.1 Heart
1.1.2 Cardiac Cycle
1.1.3 Blood Vessels
1.2 Disorders of Heart and Circulation
1.2.1 Hypertension
1.2.2 Coronary Artery Disease
1.2.3 Congestive Heart Failure
1.2.4 Cardiac Arrhythmias
1.2.5 Stroke
1.2.6 Rheumatic Heart Disease
1.2.7 Acquired Valve Disorders
1.2.8 Congenital Heart Defects
1.3 Cardiovascular Disease Diagnosis
1.3.1 Non-Imaging Techniques
1.3.2 Imaging Techniques
1.3.2.1 Radiographic Imaging
1.3.2.2 Echocardiography
1.3.2.3 Radionuclide Scanning
1.3.2.4 Magnetic Resonance Imaging
1.3.2.5 Coronary Angiography
1.3.2.6 Intravascular Ultrasound
1.3.2.7 Intracoronary Angioscopy
1.3.3 Emerging Diagnostic Modalities
1.3.3.1 In Vitro Cardiac Markers
1.3.3.2 Predictor Tests
1.3.3.3 Monoclonal Antibody-Based Imaging of Thrombosis
1.4 Treatment of Cardiovascular Disease
1.4.1 Medical Management
1.4.1.1 Traditional Medical Management
1.4.1.2 Lipid-Lowering Drugs
1.4.2 Surgical Intervention
1.4.2.1 Coronary Artery Bypass Surgery
1.4.2.2 Valve Surgery and Treatment of Congenital Heart Defects
1.4.2.3 Transmyocardial Revascularization
1.4.2.4 Surgical Management of Atrial Fibrillation
1.4.3 Transcatheter Therapies
1.4.3.1 Percutaneous Transluminal Coronary Angioplasty
1.4.3.2 Coronary Stenting
1.4.3.3 Laser Angioplasty
1.4.3.4 Atherectomy
1.4.3.5 Transcatheter Thrombectomy and Thrombolysis
1.4.3.6 Transcatheter Defect and Valve Repair
1.4.3.7 Percutaneous Transmyocardial Revascularization
1.4.3.8 Catheter Ablation of Arrhythmias
Exhibit 1-1: The Heart
Exhibit 1-2: Selected Data on Deaths and Heart Diseases, 1999
Exhibit 1-3: Estimated Costs of Cardiovascular Disease and Stroke, 2002
Exhibit 1-4: Overview of Major Heart and Circulatory Disorders
Exhibit 1-5: Comparison of Left and Right-Sided Heart Failure
Exhibit 1-6: Selected Types of Arrhythmia
Exhibit 1-7: Major Congenital Heart Defects
Exhibit 1-8: Techniques Used for Diagnosing Cardiovascular Disease
Exhibit 1-9: Principal Drugs Used in the Treatment of Cardiovascular Disease, 2002
Exhibit 1-10: Major Surgical Interventions for Cardiovascular Disease, 2002
Exhibit 1-11: Major Surgical Approaches Used to Perform Cardiothoracic Surgery
Exhibit 1-12: Transcatheter Interventions for Cardiovascular Disease, 2002
2.0 ARTERIAL CLOSURE
2.1 Femoral Closure Approaches
2.1.1 Mechanical Compression
2.1.2 Collagen Plugs
2.1.3 Suture-Mediated Closure Devices
2.1.4 Occlusion Balloon Systems
2.1.5 Other Closure Approaches
2.2 Femoral Closure Devices
2.2.1 Current Products
2.2.1.1 Abbott Laboratories (Perclose division)
2.2.1.2 Datascope
2.2.1.3 Kensey Nash/St. Jude Medical (Daig Division)
2.2.1.4 Marine Polymer Technologies
2.2.1.5 RADI Medical Systems
2.2.1.6 SUB-Q (Boston Scientific)
2.2.1.7 Vascular Solutions
2.2.2 Emerging Products
2.2.2.1 American Red Cross
2.2.2.2 Angiolink
2.2.2.3 BioInterventional
2.2.2.4 CardioDex
2.2.2.5 Cohesion Technologies
2.2.2.6 Confluent Surgical
2.2.2.7 CryoLife
2.2.2.8 Fusion Medical Technologies
2.2.2.9 Haemacure
2.2.2.10 Integrated Vascular Systems
2.2.2.11 Interventional Therapies
2.2.2.12 Medafor
2.2.2.13 Med Enclosure
2.2.2.14 Neomend
2.2.2.15 ONUX Medical
2.2.2.16 Scion Cardio-Vascular
2.2.2.17 Sutura
2.2.2.18 Therus
2.2.2.19 X-SITE Medical
2.3 Radial Access and Closure
2.4 Market Analysis
Exhibit 2-1: Approaches to Femoral Artery Closure
Exhibit 2-2: Current Femoral Closure Suppliers and Products
Exhibit 2-3: Abbott Laboratories' Perclose Products
Exhibit 2-4: Datascope's VasoSeal VHD
Exhibit 2-5: Datascope's VasoSeal ES
Exhibit 2-6: Kensey Nash's Angio-Seal
Exhibit 2-7: RADI Medical Systems' FemoStop Products
Exhibit 2-8: SUB-Q's QuickSeal
Exhibit 2-9: Vascular Solutions' Duett
Exhibit 2-10: Emerging Femoral Closure Suppliers and Devices
Exhibit 2-11: Angiolink's EVS Vascular Closure System
Exhibit 2-12: CardioDex' Epiclose
Exhibit 2-13: Sutura's SuperStitch
Exhibit 2-14: Therus' TheraSeal
Exhibit 2-15: X-SITE Medical's X-PRESS
Exhibit 2-16: Selected Radial Closure Devices
Exhibit 2-17: U.S. Market for Arterial Closure Devices, 2000-2006
Exhibit 2-18: Arterial Closure Market Shares, 2000 and 2001
3.0 DEBULKING TECHNOLOGIES
3.1 Coronary Atherectomy
3.1.1 Technique
3.1.2 Approaches and Products
3.1.2.1 Directional Atherectomy
3.1.2.2 Rotational Atherectomy
3.1.2.3 Extraction Atherectomy
3.1.3 Clinical Efficacy
3.1.4 Emerging Applications
3.1.4.1 General Debulking
3.1.4.2 Instent Restenosis
3.1.4.3 Peripheral Applications
3.1.5 Emerging Products
3.1.5.1 American BioMed
3.1.5.2 Arrow International
3.1.5.3 EndiCOR Medical
3.1.5.4 Fox Hollow Technologies
3.1.5.5 Kensey Nash
3.1.5.6 Prolifix Medical
3.1.5.7 Sherine Med
3.1.5.8 VascoMed
3.1.5.9 Xtrak Medical
3.2 Laser Angioplasty
3.2.1 Technique
3.2.2 Products and Suppliers (Spectranetics)
3.2.3 Emerging Applications
3.2.3.1 Instent Restenosis
3.2.3.2 Peripheral Vascular Disease
3.2.3.3 Cardiac Lead Wire Removal
3.2.3.4 Other Applications
3.2.3.4.1 Acute Coronary Syndromes
3.2.3.4.2 Chronic Total Occlusions
3.2.3.4.3 Saphenous Vein Graft Disease
3.3 Market Analysis
3.3.1 Procedure Forecast
3.3.2 Market Forecast
3.3.3 Competitive Analysis
Exhibit 3-1: Comparison of Coronary Atherectomy Approaches and Products
Exhibit 3-2: Guidant's AtheroCath Directional Coronary Atherectomy Products
Exhibit 3-3: Boston Scientific's Rotablator System
Exhibit 3-4: Boston Scientific's TEC System
Exhibit 3-5: TEC Versus Embolic Protection in Saphenous Vein Graft Interventions
Exhibit 3-6: Potential Debulking Applications for Atherectomy
Exhibit 3-7: Emerging Atherectomy Products and Suppliers
Exhibit 3-8: Prolifix Medical's Helixcision System
Exhibit 3-9: Xtrak Medical's Xtrak System
Exhibit 3-10: The Spectranetics Product Line
Exhibit 3-11: Emerging Laser Angioplasty Applications
Exhibit 3-12: U.S. Debulking Procedures, 2000-2006
Exhibit 3-13: U.S. Market for Debulking Products, 2000-2006
Exhibit 3-14: Atherectomy Market Shares, 2001
4.0 EMBOLIC PROTECTION
4.1 Applications
4.1.1 Saphenous Vein Graft Applications
4.1.2 Carotid Applications
4.1.3 Other Applications
4.2 Technologies and Suppliers
4.2.1 Distal Filter Devices
4.2.1.1 Abbott Laboratories/MedNova
4.2.1.1.1 CardioShield
4.2.1.1.2 NeuroShield
4.2.1.2 Boston Scientific
4.2.1.3 Cordis
4.2.1.4 Guidant
4.2.1.5 Medtronic
4.2.1.6 Microvena
4.2.1.7 Rubicon Medical
4.2.1.8 Scion Cardio-Vascular
4.2.1.9 Sulzer IntraTherapeutics
4.2.2 Distal Balloon Occlusion Devices
4.2.2.1 Abbott Laboratories/Rubicon Medical
4.2.2.2 Kensey Nash
4.2.2.3 Medtronic/PercuSurge
4.2.3 Proximal Balloon Occlusion
4.2.3.1 ArteriA Medical Science
4.2.3.2 Invatec
4.3 Procedure Forecast
4.4 Market Analysis
Exhibit 4-1: Final Results of the SAFER Clinical Trial
Exhibit 4-2: Comparison of Embolic Protection System Designs
Exhibit 4-3: Selected Distal Filter Embolic Protection Devices, 2001
Exhibit 4-4: MedNova's CardioShield/NeuroShield
Exhibit 4-5: Boston Scientific's FilterWire EX
Exhibit 4-6: Cordis' AngioGuard XP
Exhibit 4-7: Guidant's AccuNet
Exhibit 4-8: Medtronic's Interceptor
Exhibit 4-9: Microvena's TRAP VFS
Exhibit 4-10: Scion Cardio-Vascular's Sci-Pro
Exhibit 4-11: Sulzer IntraTherapeutics' IntraGuard
Exhibit 4-12: Selected Distal Occlusion Balloon Embolic Protection Devices, 2001
Exhibit 4-13: Kensey Nash's TriActiv Balloon Protected Flush Extraction System
Exhibit 4-14: Medtronic's GuardWire Plus
Exhibit 4-15: ArteriA's Parodi Anti-Embolism System
Exhibit 4-16: Invatec's Mo.Ma System
Exhibit 4-17: Cost per Year of Life Saved with Embolic Protection Compared to Other Health Investments
Exhibit 4-18: Embolic Protection Procedure Forecast, 2000-2006
Exhibit 4-19: U.S. Market for Embolic Protection Devices, 2000-2006
5.0 MECHANICAL THROMBECTOMY
5.1 Clinical Applications
5.1.1 Hemodialysis Access Grafts
5.1.2 Peripheral Vessel Clearance
5.1.3 Coronary Applications
5.1.4 Emerging Applications
5.2 Thrombectomy Approaches
5.3 Types of Mechanical Devices
5.4 Products
5.4.1 Arrow International
5.4.2 Bacchus Vascular
5.4.3 Boston Scientific
5.4.4 Edwards Lifesciences
5.4.5 EndiCOR Medical
5.4.6 IDev Technologies
5.4.7 Johnson & Johnson Cordis
5.4.8 Micro Therapeutics
5.4.9 Microvena
5.4.10 NeoVascular Technologies
5.4.11 OmniSonics Medical Technologies
5.4.12 Possis Medical
5.4.13 Straub Medical
5.4.14 Vascular Solutions
5.4.15 Xtrak Medical
5.5 Procedure Trends
5.6 Market Analysis
5.6.1 Hemodialysis Grafts
5.6.2 Peripheral Vessels
5.6.3 Coronary Vessels
Exhibit 5-1: Potential Applications for Mechanical Thrombectomy Devices
Exhibit 5-2: Overview of End-Stage Renal Disease
Exhibit 5-3: Thrombosed Hemodialysis Access Grafts, Patient Forecast, 2000-2006
Exhibit 5-4: Peripheral Thrombosis Patients Potentially Requiring Mechanical Thrombectomy, 2000-2006
Exhibit 5-5: Overview of Acute Coronary Syndromes
Exhibit 5-6: Acute Myocardial Infarction Patients Potentially Treated with Mechanical Coronary Thrombectomy, 2000-2006
Exhibit 5-7: Types of Mechanical Thrombectomy Devices
Exhibit 5-8: Selected Mechanical Thrombectomy Devices Targeting Hemodialysis Graft Clearance, 2002
Exhibit 5-9: Selected Mechanical Thrombectomy Devices Targeting Coronary and Peripheral Applications, 2002
Exhibit 5-10: Arrow-Trerotola Percutaneous Thrombectomy Device
Exhibit 5-11: Bacchus Vascular's Solera Thrombectomy Catheter
Exhibit 5-12: Boston Scientific's Oasis Thrombectomy System
Exhibit 5-13: Edwards Lifesciences’ Thrombex PMT System
Exhibit 5-14: EndiCOR Medical's X-Sizer System
Exhibit 5-15: Johnson & Johnson Cordis' Hydrolyzer
Exhibit 5-16: Micro Therapeutics' Castaneda Over-the-Wire Brush
Exhibit 5-17: Microvena's HELIX Clot Buster
Exhibit 5-18: Neovascular Technologies' Gelbfish-Endovac System
Exhibit 5-19: Possis Medical's AngioJet Rheolytic Thrombectomy System
Exhibit 5-20: Straub Medical's Rotarex System
Exhibit 5-21: Vascular Solutions' Acolysis System
Exhibit 5-22: Xtrak Medical's XTD System
Exhibit 5-23: Mechanical Thrombectomy, Procedure Forecast by Segment, 2000-2006
Exhibit 5-24: Mechanical Thrombectomy Devices, Market Forecast by Segment, 2000-2006
Exhibit 5-25: Hemodialysis Graft Thrombectomy Procedures and Market, Forecasts, 2000-2006
Exhibit 5-26: Hemodialysis Graft Thrombectomy Systems, Supplier Shares, 2001
Exhibit 5-27: Peripheral Vessel Thrombectomy Procedures and Market, Forecast, 2000-2006
Exhibit 5-28: Peripheral Vessel Thrombectomy Systems, Supplier Shares, 2001
Exhibit 5-29: Coronary Thrombectomy Procedures and Market, Forecast, 2000-2006
6.0 PERCUTANEOUS CLOSURE OF HEART DEFECTS
6.1 Patent Ductus Arteriosus
6.1.1 PDA Closure Devices
6.1.1.1 AGA Medical
6.1.1.2 Cook Cardiology
6.1.2 Product Trends
6.1.3 Clinical Outcomes
6.2 Atrial Septal Defect
6.2.1 Closure Device Design Criteria
6.2.2 Products
6.2.2.1 AGA Medical
6.2.2.2 Custom Medical Devices
6.2.2.3 W.L. Gore
6.2.2.4 Microvena
6.2.2.5 NMT Medical
6.2.2.6 Dr. Osypka GmbH
6.3 Ventricular Septal Defect
6.3.1 Implantation Options
6.3.2 Closure Devices
6.3.2.1 AGA Medical
6.3.2.2 NMT Medical
6.3.3 Clinical Outcomes
6.4 Patent Foramen Ovale
6.4.1 Cryptogenic Stroke and Paradoxical Embolism
6.4.1.1 Role of Patent Foramen Ovale in Paradoxical Embolism
6.4.1.2 Role of Patent Foramen Ovale in Migraine with Aura
6.4.1.3 Prevention of Stroke Recurrence
6.4.1.4 Stroke Patients Potentially Treated
6.4.2 Closure Devices
6.4.2.1 AGA Medical
6.4.2.2 NMT Medical
6.4.3 Clinical Outcomes
6.5 Potential Patient Population
6.6 Procedure Forecast
6.7 Market Analysis
Exhibit 6-1: Overview of Patent Ductus Arteriosus
Exhibit 6-2: Selected Trancatheter Patent Ductus Arteriosus Closure Devices, 2002
Exhibit 6-3: Selected Transcatheter PDA Closure Devices, 2002
Exhibit 6-4: Comparison of Rashkind Umbrella Occluder and Gianturco Coil for Percutaneous Closure of Patent Ductus Arteriosus
Exhibit 6-5: Results of Five PDA Closure Devices in 354 Patients
Exhibit 6-6: Major Observations on Five PDA Closure Devices
Exhibit 6-7: Overview of Atrial Septal Defect
Exhibit 6-8: Design Criteria for Ideal ASD Closure Device
Exhibit 6-9: Selected Trancatheter Atrial Septal Defect Repair Devices, 2002
Exhibit 6-10: Selected Transcatheter ASD Repair Devices, 2002
Exhibit 6-11: Selected Results of Pivotal Trial of Amplatzer Septal Occluder
Exhibit 6-12: Overview of Ventricular Septal Defect
Exhibit 6-13: Overview of PatentForamen Ovale
Exhibit 6-14: Patent Foramen Ovale and Cryptogenic Stroke
Exhibit 6-15: Potential Candidates for Transcatheter Defect Closure, 2001
Exhibit 6-16: Potential Candidates for Transcatheter Defect Closure, Forecast, 2000-2006
Exhibit 6-17: Transcatheter Defect Closure, Procedure Forecast, 2000-2006
Exhibit 6-18: Transcatheter Defect Closure Devices, Market Forecast, 2000-2006
Exhibit 6-19: Transcatheter Defect Repair Devices, Supplier Shares, 2001
7.0 EMERGING TECHNOLOGIES
7.1 Emerging Reperfusion Therapies
7.1.1 Hyperoxemic Reperfusion
7.1.1.1 TherOx
7.1.2 Intravascular Hypothermia
7.1.2.1 Alsius
7.1.2.2 INNERCOOL therapies
7.1.2.3 Radiant Medical
7.1.3 Market Assessment
7.2 Management of Vulnerable Plaque
7.2.1 Definition and Characterization of Vulnerable Plaque
7.2.2 Emerging Diagnostic Techniques
7.2.2.1 Transcatheter Techniques
7.2.2.1.1 Angioscopy
7.2.2.1.2 Intravascular Ultrasound
7.2.2.1.3 Intravascular Elastography
7.2.2.1.4 Intravascular Optical Coherence Tomography
7.2.2.1.5 Intravascular Thermography
7.2.2.1.6 Intravascular Electrical Impedance Imaging
7.2.2.1.7 Intravascular (Photonic) Spectroscopy
7.2.2.1.8 Intravascular and Transesophogeal MRI
7.2.2.1.9 Intravascular Laser Doppler
7.2.2.1.10 Intravascular Shear Stress Measurement
7.2.2.2 Non-Invasive Techniques
7.2.2.3 Non-Invasive vs. Invasive Assessment of Global and Focal Risk
7.2.3 Treatment of Vulnerable Plaque
7.2.4 Market Assessment
Exhibit 7-1: Emerging Reperfusion Therapies
Exhibit 7-2: The TherOx AO System
Exhibit 7-3: Intravascular Hypothermia Products and Suppliers
Exhibit 7-4: Alsius' CoolGard System
Exhibit 7-5: INNERCOOL therapies' Celsius Control System
Exhibit 7-6: Radiant Medical's SetPoint System
Exhibit 7-7: Overview of Plaque Classification
Exhibit 7-8: Plaque Rupture
Exhibit 7-9: Selected Transcatheter Approaches for Vulnerable Plaque Diagnosis
Exhibit 7-10: Selected Noninvasive Approaches for Vulnerable Plaque Diagnosis
Exhibit 7-11: Potential Vulnerable Plaque Treatment Options
8.0 COMPANY PROFILES
8.1 Abbott Laboratories
8.2 AGA Medical Corporation
8.3 Arrow International Inc.
8.4 ArteriA Medical Science Inc.
8.5 Bacchus Vascular Inc.
8.6 Boston Scientific Corporation
8.7 Datascope Corporation
8.8 Guidant Corporation
8.9 Johnson & Johnson
8.10 Kensey Nash Corporation
8.11 Medtronic Inc.
8.12 Micro Therapeutics, Inc.
8.13 Microvena Corporation/EndiCOR Medical Inc.
8.14 NMT Medical Inc.
8.15 Possis Medical Inc.
8.16 Rubicon Medical Corporation
8.17 Scion Cardio-Vascular Inc.
8.18 Spectranetics Corporation
8.19 St. Jude Medical Inc.
8.20 Vascular Solutions Inc.