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Although stents will continue to dominate the interventional coronary revascularization products market, the excitement surrounding drug-eluting models tends to overshadow other important product segments. Despite their
relative maturity, PTCA products are projected to see 12% annual growth, which will reflect rising procedures and
new products, such as total occlusion crossing devices, that will further expand indications to encompass
increasingly complex cardiovascular disease. Endovascular brachytherapy systems will present a window of
opportunity for suppliers, with total sales exceeding $560 million for the period from 2002 through 2006; although
the caseload with instent restenosis potentially requiring treatment will decline dramatically with the use of
drug-eluting stents after 2002, endovascular brachytherapy's penetration of that caseload will increase sharply,
contributing to continued, albeit gradually declining sales. This report examines the current and emerging U.S. markets for interventional coronary revascularization technologies, as well as the product offerings and competitive landscape of the manufacturers shaping this
dynamic market. In addition, the analysis forecasts the outlook for this landscape and provides in-depth profiles of
the key companies in this marketplace. EXECUTIVE SUMMARY I. Trends in Coronary Revascularization II. PTCA Products III. Coronary Stents IV. Antirestenosis Technologies V. Companies 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 2.1 Technique 2.2 Clinical Use and Efficacy 2.2.1 Complications 2.2.2 Outcomes versus Competitive Techniques 2.2.3 Non-Femoral Access 2.2.4 Expanding Applications 2.3 Products and Suppliers 2.3.1 Traditional PTCA Devices 2.3.1.1 Balloon Catheters 2.3.1.1.1 Major Designs 2.3.1.1.2 Products 2.3.1.1.3 Pricing 2.3.1.1.4 Emerging Products 2.3.1.2 Guiding Catheters 2.3.1.2.1 Design Goals 2.3.1.2.2 Other Features 2.3.1.2.3 Pricing and Suppliers 2.3.1.3 Guidewires 2.3.1.4 Vascular Access Sheaths 2.3.1.5 Other PTCA Accessories 2.3.2 New and Emerging PTCA Devices 2.3.2.1 Cutting Balloon 2.3.2.1.1 Regulatory Status 2.3.2.1.2 Clinical Results 2.3.2.2 Total Occlusion Crossing Devices 2.3.2.2.1 Competitive Analysis 2.4 Procedure Forecasts 2.5 Market Analysis 2.5.1 Balloon Catheters 2.5.1.1 Competitive Analysis 2.5.2 Guiding Catheters 2.5.3 Guidewires 2.5.4 PTCA Accessories 2.5.5 Total Occlusion Crossing Devices 3.1 Technique 3.1.1 Stent Deployment 3.1.1.1 Direct Stenting 3.1.1.2 Delivery Systems 3.1.2 Adjuvant Anti-Thrombotic Therapy 3.1.2.1 Current Regimens 3.1.2.2 Coated Stents 3.1.2.2.1 Competitive Analysis 3.1.3 Stent Imaging 3.1.3.1 Potential Benefits and Limitations 3.1.3.2 JOMED Josonics Flex Delivery System 3.2 Indications 3.2.1 Small Vessel Stenting 3.2.2 Saphenous Vein Graft Stenting 3.2.3 Stenting in Long Lesions and Diffuse Disease 3.2.4 Multivessel Stenting 3.2.5 Stenting in Acute Myocardial Infarction 3.2.6 Left Main Coronary Artery Stenting 3.3 Training Requirements 3.4 Cost of POBA versus PTCA with Stenting 3.5 Products and Suppliers 3.5.1 Bare Stents 3.5.1.1 Competitive Analysis 3.5.2 Drug Eluting Stents 3.5.2.1 Competitive Analysis 3.6 Procedure Forecasts 3.7 Market Analysis 3.7.1 Sales Model and Forecast 3.7.1.1 Bare Stents 3.7.1.2 Drug Eluting Stents 3.7.2 Supplier Shares 3.7.3 Near-Term Competitive Scenario 3.7.4 Future Competitive Scenario 4.1 Mechanisms of Restenosis 4.2 Overview of Antirestenosis Technologies 4.3 Stent-Based Antirestenosis Programs 4.4 Endovascular Brachytherapy Table of Contents 4.4.1 Radiation Sources 4.4.2 Radioactive Stents 4.4.2.1 Clinical Experience 4.4.2.2 4.4.2.3 Other Developments 4.4.2.3.1 On-Site Radioactive Stent Preparation 4.4.2.3.2 Intravascular Activation Brachytherapy 4.4.2.4 Market Limiters 4.4.3 Guidewire/Sourcetrain Systems 4.4.3.1 Competitive Analysis 4.4.4 Other Endovascular Brachytherapy Platforms 4.4.4.1 Balloon-Based Systems 4.4.4.2 X-Ray Catheter Delivery Systems 4.4.4.2.1 Competitive Analysis 4.4.4.3 Intracoronary Infiltrating Catheter 4.5 Drug Therapy 4.5.1 Systemic Drug Delivery 4.5.2 Localized Drug Delivery 4.5.2.1 Coatings 4.5.2.2 Liposomes (Endovasc) 4.5.2.3 Specialized Drug Delivery Catheters 4.5.2.3.1 Competitive Analysis 4.6 Gene Therapy 4.6.1 Competitive Analysis 4.7 Energy-Based Therapies 4.7.1 Cryotherapy 4.7.1.1 Competitive Analysis 4.7.2 Intravascular Sonotherapy 4.7.2.1 Competitive Analysis 4.7.3 Photodynamic Therapy/Photoangioplasty 4.7.3.1 Competitive Analysis 4.7.4 Thermal Therapy 4.8 Market Analysis 4.8.1 Endovascular Brachytherapy 4.8.1.1 Procedure Forecast 4.8.1.2 Market Forecast 4.8.1.3 Supplier Shares 4.8.2 Other Competing Technologies 5.1 Abbott Laboratories 5.2 Angiotech Pharmaceuticals Inc. 5.3 Biocompatibles International plc 5.4 Boston Scientific Corporation 5.5 Cook Group 5.6 Guidant Corporation 5.7 Implant Sciences Corporation 5.8 Johnson & Johnson 5.9 JOMED NV 5.10 Medtronic Inc. 5.11 Merit Medical Systems Inc. 5.12 Novoste Corporation 5.13 Radiance Medical Systems Inc.
* Single License allows for report sharing within one company location.
Coronary stents represent one of the most successful product launches in the history of the medical products industry and the latest market developments are about to generate a second, major growth phase by largely
solving the single greatest challenge associated with interventional revascularization: restenosis. The imminent
impact of drug-eluting stents will enable the treatment of many patients previously requiring surgical intervention,
thereby expanding overall PTCA and stenting caseloads and increasing product utilization per patient to generate
$5.3 billion in U.S. sales by 2006.
SECTION 1: OVERVIEW OF CARDIOVASCULAR DISORDERS
SECTION 2: PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY
SECTION 3: CORONARY STENTS
SECTION 4: ANTIRESTENOSIS TECHNOLOGIES
SECTION 5: COMPANY PROFILES
APPENDIX: COMPANY LIST
Company listing available upon request.
** Corporate License allows for report sharing within all company locations.
This report is listed in the following markets:
Cardiovascular