U.S. Opportunities in Interventional Coronary Revascularization

Companies Covered

Abbott Laboratories

Angiotech Pharmaceuticals Inc.

Biocompatibles International plc

Boston Scientific Corporation

Cook Group

Guidant Corporation

Implant Sciences Corporation

Johnson & Johnson

JOMED NV

Medtronic Inc.

Merit Medical Systems Inc.

Novoste Corporation

Radiance Medical Systems Inc.

Table of Contents

EXECUTIVE SUMMARY

Trends in Coronary Revascularization

PTCA Products

Coronary Stents

Antirestenosis Technologies

Companies

 

Summary Exhibit 1: U.S. Interventional Coronary Revascularization Market by Major Category, 1999-2006

Summary Exhibit 2: Coronary Revascularization Procedures by Type, 1999-2006

Summary Exhibit 3: U.S. PTCA Product Markets, 1999-2006

Summary Exhibit 4: Coronary Stents, Market Forecast, 1999-2006

Summary Exhibit 5: Endovascular Brachytherapy, Market Forecast, 2000-2006

Summary Exhibit 6: Interventional Coronary Revascularization Supplier Shares, 2001

Summary Exhibit 7: Interventional Coronary Revascularization Supplier Shares by Segment, 2001

 

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 PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY

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 Corazon Technologies

2.3.2.2.2 IntraLuminal Therapeutics

2.3.2.2.3 LuMend

2.3.2.2.4 Spectranetics

2.3.2.2.5 Stereotaxis

2.4 Procedure Forecasts

2.5 Market Analysis

2.5.1 Balloon Catheters

2.5.1.1 Boston Scientific Market Share

2.5.1.2 Other Supplier Shares

2.5.2 Guiding Catheters

2.5.3 Guidewires

2.5.4 PTCA Accessories

2.5.5 Total Occlusion Crossing Devices

 

Exhibit 2-1: Impact of Age on Results of Angioplasty

Exhibit 2-2: Comparison of PTCA and New Approaches to Coronary Intervention

Exhibit 2-3: Indications for Percutaneous Transluminal Coronary Angioplasty

Exhibit 2-4: Standard PTCA Balloon Catheter Designs

Exhibit 2-5: Selected Standard PTCA Balloon Catheters, 2002

Exhibit 2-6: Selected Guiding Catheters, 2002

Exhibit 2-7: Selected PTCA Guidewires, 2002

Exhibit 2-8: Overview of Selected PTCA Accessories

Exhibit 2-9: New and Emerging PTCA Devices

Exhibit 2-10: Boston Scientific's Cutting Balloon

Exhibit 2-11: IntraLuminal Therapeutics' Safe-Steer System

Exhibit 2-12: LuMend's Frontrunner CTO Catheter

Exhibit 2-13: Coronary Revascularization, Procedure Forecast by Type, 1999-2006

Exhibit 2-14: PTCA Products, Market Forecast by Segment, 1999-2006

Exhibit 2-15: PTCA Balloon Catheters, Market Forecast, 1999-2006

Exhibit 2-16: PTCA Balloon Catheters, Supplier Shares, 2001

Exhibit 2-17: PTCA Guiding Catheters Market Forecast, 1999-2006

Exhibit 2-18: PTCA Guiding Catheter Supplier Shares, 2001

Exhibit 2-19: PTCA Guidewires, Market Forecast, 1999-2006

Exhibit 2-20: PTCA Guidewires, Supplier Shares, 2001

Exhibit 2-21: PTCA Accessories Market, 1999-2006

Exhibit 2-22: PTCA Accessories, Supplier Shares, 2001

Exhibit 2-23: Total Occlusion Crossing Devices Market Forecast, 2000-2006

 

3.0 CORONARY STENTS

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 Abbott Laboratories/Biocompatibles International

3.1.2.2.2 Cordis

3.1.2.2.3 JOMED

3.1.2.2.4 Medtronic

3.1.2.2.5 PHYTIS Medical Devices

3.1.2.2.6 Sorin Biomedica

3.1.2.2.7 Other Developments

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 Abbott Laboratories/Biocompatibles International

3.5.1.2 Boston Scientific

3.5.1.2.1 Medinol NIR Stents

3.5.1.2.2 Self-Expanding Stents

3.5.1.2.3 Emerging Products

3.5.1.2.4 Relationship with Medinol

3.5.1.3 Cook

3.5.1.4 Cordis

3.5.1.4.1 Palmaz-Schatz Stents

3.5.1.4.2 Bx Velocity Stents

3.5.1.4.3 Emerging Products

3.5.1.5 Guidant

3.5.1.5.1 Multi-Link Duet

3.5.1.5.2 Multi-Link Tristar

3.5.1.5.3 Multi-Link Tetra

3.5.1.5.4 Multi-Link Penta, Zeta

3.5.1.5.5 Multi-Link Vision

3.5.1.5.6 Multi-Link Specialty Stents

3.5.1.6 JOMED

3.5.1.6.1 JOSTENT Flex

3.5.1.6.2 JOSTENT Coronary Stent Graft

3.5.1.6.3 JOSTENT Bifurcation and Sidebranch

3.5.1.6.4 U.S. Strategy

3.5.1.7 Medtronic

3.5.1.7.1 Wiktor Stents

3.5.1.7.2 BeStent Products

3.5.1.7.3 Arterial Vascular Engineering Products

3.5.1.7.4 Current and Emerging Products

3.5.1.7.5 Loss of Rapid Exchange

3.5.1.8 Other Developments

3.5.1.8.1 CardioVasc

3.5.1.8.2 MIVI Technologies

3.5.1.8.3 Advanced Stent Technologies

3.5.2 Drug Eluting Stents

3.5.2.1 Cordis

3.5.2.1.1 Early Results

3.5.2.1.2 RAVEL

3.5.2.1.3 SIRIUS and Other Studies

3.5.2.1.4 SurModics

3.5.2.1.5 NitroMed

3.5.2.2 Abbott Laboratories/Biocompatibles International

3.5.2.2.1 Abbott Laboratories

3.5.2.2.2 Batimastat

3.5.2.2.3 Dexamethasone

3.5.2.2.4 Estradiol

3.5.2.2.5 Other Compounds

3.5.2.3 Boston Scientific

3.5.2.3.1 Angiotech Pharmaceuticals

3.5.2.3.2 Quanam Medical Corporation

3.5.2.4 Cook

3.5.2.4.1 ASPECT

3.5.2.4.2 ELUTES

3.5.2.4.3 Other Studies

3.5.2.4.4 Guidant Agreement

3.5.2.5 Guidant

3.5.2.5.1 PharmaLink

3.5.2.5.2 Achieve

3.5.2.6 Medtronic

3.5.2.7 Other Drug Eluting Stent Programs

3.5.2.7.1 Biosensors International

3.5.2.7.2 Conor Medsystems

3.5.2.7.3 Endovasc

3.5.2.7.4 Implant Sciences/CardioTech International

3.5.2.7.5 JOMED

3.5.2.7.6 Terumo

3.5.2.7.7 Other Stent Coatings

3.5.2.8 Gene Therapy Stents

3.5.2.9 Biodegradable Stents

3.5.2.9.1 Igaki-Tamai Stent

3.5.2.9.2 Other Biodegradable Stent Programs

3.5.2.10 Other Developments

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

 

Exhibit 3-1: Study Outcomes Showing Benefits of Direct Stenting

Exhibit 3-2: Comparison of Three Post-Stenting Antithrombotic Drug Regimens

Exhibit 3-3: Current and Emerging Antithrombotic Coronary Stents, 2002

Exhibit 3-4: Emerging Indications for Coronary Stenting

Exhibit 3-5: FDA Coronary Stent Approvals by Year, 1998-2001

Exhibit 3-6: Selected Coronary Stents

Exhibit 3-7: Overview of Drug-Eluting Stent Technology

Exhibit 3-8: Necessary Drug Properties for Drug Eluting Stents

Exhibit 3-9: Selected Drug Eluting Stent Programs, 2002

Exhibit 3-10: Selected Results of RAVEL Study

Exhibit 3-11: Results of TAXUS I  Trial

Exhibit 3-12: Final Results of the SCORE Trial

Exhibit 3-13: Results of ASPECT Trial

Exhibit 3-14: Results of ELUTES Study

Exhibit 3-15: Clinical Results with the Igaki-Tamai Biodegradable Stent

Exhibit 3-16: CABG Surgery versus Transcatheter Approaches for Revascularization

Exhibit 3-17: Coronary Stenting by Type, Procedure Forecast, 1999-2006

Exhibit 3-18: Coronary Stent Usage by Vessels Treated, Device Forecast, 1999-2006

Exhibit 3-19: Coronary Stents by Type, Market Forecast, 1999-2006

Exhibit 3-20: Coronary Stents, Supplier Shares, 1998-2001

Exhibit 3-21: Anticipated Timing of Selected Drug Eluting Stent Programs

Exhibit 3-22: Comparison of Drug-Eluting Stent Studies

 

4.0 ANTIRESTENOSIS TECHNOLOGIES

4.1 Mechanisms of Restenosis

4.2 Overview of Antirestenosis Technologies

4.3 Stent-Based Antirestenosis Programs

4.4 Endovascular Brachytherapy

4.4.1 Radiation Sources

4.4.2 Radioactive Stents

4.4.2.1 Clinical Experience

4.4.2.2 Cordis/IsoStent

4.4.2.3 Guidant

4.4.2.4 Implant Sciences

4.4.2.5 InnerDyne

4.4.2.6 MoBeta

4.4.2.7 Other Developments

4.4.2.7.1 On-Site Radioactive Stent Preparation

4.4.2.7.2 Intravascular Activation Brachytherapy

4.4.2.8 Market Limiters

4.4.3 Guidewire/Sourcetrain Systems

4.4.3.1 Boston Scientific

4.4.3.2 Cordis

4.4.3.3 Guidant

4.4.3.3.1 Galileo

4.4.3.3.2 Peripheral System

4.4.3.4 JOMED

4.4.3.5 Novoste

4.4.3.6 Theragenics

4.4.3.7 Indications

4.4.4 Other Endovascular Brachytherapy Platforms

4.4.4.1 Balloon-Based Systems

4.4.4.1.1 Radiance Medical Systems

4.4.4.2 X-Ray Catheter Delivery Systems

4.4.4.2.1 Medtronic

4.4.4.2.2 Photoelectron

4.4.4.2.3 Xoft microTube

4.4.4.3 Intracoronary Infiltrating Catheter

4.5 Drug Therapy

4.5.1 Systemic Drug Delivery

4.5.1.1 AtheroGenics

4.5.1.2 Sirolimus

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 Angiogene

4.5.2.3.2 Boston Scientific

4.5.2.3.3 EndoBionics

4.6 Gene Therapy

4.6.1 AVI BioPharma

4.6.2 Cardion

4.6.3 Cell Genesys

4.6.4 GenVec

4.6.5 Introgen Therapeutics

4.6.6 Transgene

4.6.7 Valentis

4.7 Energy-Based Therapies

4.7.1 Cryotherapy

4.7.1.1 CryoCath Technologies

4.7.1.2 CryoVascular Systems

4.7.2 Intravascular Sonotherapy

4.7.2.1 Angiosonics

4.7.2.2 PharmaSonics

4.7.3 Photodynamic Therapy/Photoangioplasty

4.7.3.1 DUSA Pharmaceuticals

4.7.3.2 Miravant Medical Technologies

4.7.3.3 Pharmacyclics

4.7.3.4 QLT

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

 

Exhibit 4-1: Mechanisms of Restenosis

Exhibit 4-2: Summary of Antirestenosis Technologies

Exhibit 4-3: Comparison of Endovascular Brachytherapy Approaches

Exhibit 4-4: Overview of Radioactive Stents

Exhibit 4-5: Selected Radioactive Stent Programs, 2002

Exhibit 4-6: Endovascular Brachytherapy: Guidewire and Sourcetrain Systems and Suppliers, 2001

Exhibit 4-7: Cordis' Checkmate System

Exhibit 4-8: Guidant's Galileo System

Exhibit 4-9: Clinical Summary of the INHIBIT Trial

Exhibit 4-10: Novoste's Beta-Cath System

Exhibit 4-11: Clinical Results of START and START 40 Trials

Exhibit 4-12: Other Endovascular Brachytherapy Products and Suppliers, 2002

Exhibit 4-13: Radiance Medical Systems’ RDX System

Exhibit 4-14: Results from the BRITE Study

Exhibit 4-15: Selected Pharmaceutical Agents Ineffective Against Restenosis

Exhibit 4-16: Selected Pharmaceutical Agents Being Investigated for Restenosis, 2002

Exhibit 4-17: Overview of Localized Drug Delivery Methods as Restenosis Therapy

Exhibit 4-18: Selected Gene Therapy Approaches to Treating Restenosis

Exhibit 4-19: Selected Energy-Based Therapies for the Treatment of Restenosis, 2002

Exhibit 4-20: SILENT vs. Beta-Cath Studies: Angiographic Restenosis Rates

Exhibit 4-21: Selected Photodynamic Therapy Programs for Restenosis, 2002

Exhibit 4-22: Preclinical Results of Miravant’s PhotoPoint Technology for Restenosis

Exhibit 4-23: Endovascular Brachytherapy, Procedure Forecast, 2000-2006

Exhibit 4-24: Endovascular Brachytherapy Products, Market Forecast, 2000-2006

Exhibit 4-25: Endovascular Brachytherapy, Supplier Shares, 2001

 

5.0 COMPANY PROFILES

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.

 

APPENDIX:  COMPANY LIST