High Growth U.S. Adjunctive Coronary Transcatheter Markets

Companies Covered

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.

Table of Contents

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.