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AFx, Inc
Appriva Medical, Inc. (ev3, Inc.)
AtriCure, Inc.
Biotronik GmbH & Company
Boston Scientific Corporation (EP Technologies, Cardiac Pathways)
Cardima, Inc.
CardioFocus, Inc.
CardioOptics, Inc.
Cardiome Pharma Corporation
CathEffects LLC
CryoCath Technologies, Inc.
CryoCor, Inc.
Endocardial Solutions, Inc.
EP MedSystems, Inc.
Epicor, Inc.
Guidant Corporation
Irvine Biomedical Inc.
Johnson & Johnson
Medtronic, Inc.
Rhythm Technologies, Inc.
SNIA Group (ELA Medical, Sorin Biomedica)
Stereotaxis, Inc.
St. Jude Medical, Inc.
Transurgical, Inc.
EXECUTIVE SUMMARY
Overview of Atrial Fibrillation
Drug Therapy
Surgical Management
Implantable Devices
Catheter-Based Ablation Technologies
Adjunctive Transcatheter Technologies
Stroke Prevention
Internal Cardioversion
Competitive Environment
Summary Exhibit 1: Atrial Fibrillation Products, Market Forecast, 2001-2010
Summary Exhibit 2: Trend in Atrial Fibrillation Population by Age, 2001-2010
Summary Exhibit 3: Overview of Atrial Fibrillation Classification Schemes
Summary Exhibit 4: Atrial Fibrillation Drug Therapy, Patients and Product Markets, 2001-2010
Summary Exhibit 5: Selected Surgical Ablation Technologies Used for Atrial Fibrillation, 2002
Summary Exhibit 6: Surgical Ablation of Atrial Fibrillation, Procedure and Market Forecasts, 2001-2010
Summary Exhibit 7: FDA Approved Implantable Devices Targeting Atrial Fibrillation, 2002
Summary Exhibit 8: Atrial Fibrillation Implantable Devices, Market Forecast, 2001-2010
Summary Exhibit 9: Selected Catheter-Based Ablation Technologies, 2002
Summary Exhibit 10: Transcatheter AF Ablation, Patient and Market Forecast, 2001-2010
Summary Exhibit 11: Stroke Prevention, Patient and Market Forecasts, 2005-2010
Summary Exhibit 12: Internal Cardioversion, Procedure and Market Forecasts, 2002-2010
1.0 OVERVIEW OF ATRIAL FIBRILLATION
1.1 Cardiovascular System Components and Functions
1.1.1 Heart
1.1.2 Cardiac Cycle
1.1.3 Blood Vessels
1.1.4 Heart Valves
1.1.5 Electrical Conduction System
1.2 Cardiac Rhythm Disorders
1.3 Atrial Fibrillation
1.3.1 Description
1.3.2 Classifications
1.3.2.1 Lone
1.3.2.2 Temporal Patterns
1.3.2.2.1 Paroxysmal
1.3.2.2.2 Persistent
1.3.2.2.3 Permanent
1.3.2.3 Other Types
1.3.3 Epidemiology and Prognosis
1.3.3.1 Prevalence
1.3.3.2 Incidence
1.3.3.3 Prognosis
1.3.4 Pathological Triggers and Associated Conditions
1.3.4.1 Acute Causes
1.3.4.1.1 Tachycardia-Induced Tachycardia
1.3.4.1.2 Post-operative AF
1.3.4.2 AF Without Associated Heart Disease
1.3.4.3 AF With Associated Heart Disease
1.3.4.4 Neurogenic AF
1.3.5 Presentation and Sequelae
1.3.5.1 Atrial Factors
1.3.5.1.1 Pathology of Atrium in AF
1.3.5.1.2 Mechanisms of AF
1.3.5.2 Hemodynamic Consequences of AF
1.3.5.3 Thromboembolism
1.3.5.3.1 Pathophysiology of Thrombus Formation
1.3.5.3.2 Clinical Implications
1.3.6 Patient Evaluation and Diagnosis
1.3.6.1 Minimum Evaluation of the Patient with AF
1.3.6.2 Additional Investigation of Selected Patients with Atrial Fibrillation
1.3.6.2.1 Holter Monitoring and Exercise Testing
1.3.6.2.2 Transesophageal Echocardiography
1.3.6.2.3 Electrophysiology Study
1.3.7 Treatment Approaches
1.3.7.1 Drug Therapy: Rhythm Control vs. Rate Control
1.3.8 Acute Management
1.3.8.1 Restoration of Sinus Rhythm
1.3.8.1.1 Pharmacological Cardioversion
1.3.8.1.2 Electrical Cardioversion
1.3.8.2 Prevention of Thromboembolism
1.3.9 Long-term Management
1.3.9.1 Maintenance of Sinus Rhythm
1.3.9.1.1 Pharmacological Therapy
1.3.9.1.2 Surgical Ablation
1.3.9.1.3 Catheter Ablation
1.3.9.1.4 Internal Atrial Defibrillators
1.3.9.1.5 Permanent Pacing
1.3.9.2 Ventricular Rate Control
1.3.9.2.1 Pharmacologic Therapy
1.3.9.2.2 AV Nodal Ablation
1.3.9.2.3 AV Node Modification
1.3.9.2.4 Vagal Nerve Stimulation
1.3.10 Thromboembolic Risk Management in AF
1.3.10.1 Acute Prevention of Thromboembolism
1.3.10.2 Reduction of Future Thromboembolic Risk in AF patients
1.3.10.3 Interventional Reduction of AF Stroke Risk
1.3.11 Hybrid Therapy
1.3.11.1 Drugs and Electrical Cardioversion
1.3.11.1.1 Improving Efficacy of Cardioversion
1.3.11.1.2 Reduction of Atrial Remodeling
1.3.11.2 Drugs and Catheter Ablation
1.3.11.2.1 Limited Linear Atrial Ablation
1.3.11.2.2 Ablation of AF Initiating Foci
1.3.11.3 Drugs and Pacemakers
1.3.11.3.1 Drugs and Pace-Termination
1.3.11.3.2 Drugs and Pacing Prevention
1.3.11.4 Conclusion
1.4 AF Patient Profiles
1.4.1 Trend in AF Patients by Age Group
1.4.2 Trend in Patients by Type of AF
1.4.3 AF Patients by Treatment
Exhibit 1-1: The Heart
Exhibit 1-2: Overview of Major Cardiac Arrhythmias
Exhibit 1-3: Overview of Atrial Fibrillation Classification Schemes
Exhibit 1-4: Selected Atrial Fibrillation Statistics
Exhibit 1-5: Prevalence of Atrial Fibrillation By Patient Age
Exhibit 1-6: Projected Prevalence of Atrial Fibrillation in the U.S., 1995-2050
Exhibit 1-7: Atrial Fibrillation: Acute Causes and Related Conditions
Exhibit 1-8: ATRIA Study: Baseline Characteristics of Atrial Fibrillation Patients
Exhibit 1-9: Diagnosis of Atrial Fibrillation
Exhibit 1-10: Treatment Options for Atrial Fibrillation
Exhibit 1-11: Catheter Ablation Approaches for Atrial Fibrillation
Exhibit 1-12: Stroke Rates in Relation to Age Among Patients with Atrial Fibrillation
Exhibit 1-13: Risk Factors for Ischemic Stroke and Systemic Embolism in Patients with Non-Valvular Atrial Fibrillation
Exhibit 1-14: Atrial Fibrillation Patients by Age Group, 2001-2010
Exhibit 1-15: Atrial Fibrillation Patients by Temporal Pattern, 2001-2010
Exhibit 1-16: Atrial Fibrillation Patients Treated, 2001-2010
2.0 PHARMACOLOGIC THERAPY FOR ATRIAL FIBRILLATION
2.1 Classification Systems
2.2 Drug Therapy Algorithms
2.3 Antiarrhythmic Drug Therapy
2.3.1 Pharmacological Cardioversion
2.3.1.1 Recommendations for Cardioversion
2.3.1.2 Pharmaceutical Options With Proven Efficacy
2.3.1.2.1 Amiodarone
2.3.1.2.2 Dofetilide
2.3.1.2.3 Flecainide
2.3.1.2.4 Ibutilide
2.3.1.2.5 Propafenone
2.3.1.2.6 Qunidine
2.3.1.3 Other Agents
2.3.2 Pharmacological Maintenance of Sinus Rhythm
2.3.3 Pharmacological Rate Control
2.3.3.1 Beta-Blockers
2.3.3.2 Calcium Channel Blockers
2.3.3.3 Digoxin
2.3.3.4 Other Options
2.3.3.5 Recommendations for Rate Control
2.3.4 Rhythm Control versus Rate Control
2.3.4.1 PIAF Study
2.3.4.2 STAF Study
2.3.4.3 AFFIRM Trial
2.3.4.4 RACE Study
2.3.4.5 Conclusions
2.3.5 Investigational Antiarrhythmic Drugs
2.4 Antithrombotic Drug Therapy
2.5 Patient and Treatment Forecasts
2.6 Market Analysis
2.6.1 Anticoagulants
2.6.2 Antiarrhythmic Drugs
2.6.3 Rate Control Drugs
Exhibit 2-1: The Vaughan Williams Classification of Antiarrhythmic Drug Actions
Exhibit 2-2: Atrial Fibrillation Drug Therapy Algorithms
Exhibit 2-3: Effective Agents for Pharmacological Cardioversion of Atrial Fibrillation
Exhibit 2-4: Less Effective or Incompletely Studied Agents for Pharmacological Cardioversion of Atrial Fibrillation
Exhibit 2-5: Antiarrhythmic Drug Options for Maintaining Sinus Rhythm in AF
Exhibit 2-6: Treatment Algorithm for Antiarrhythmic Drug Therapy for Maintenance of Sinus Rhythm in Recurrent Paroxysmal or Persistent AF
Exhibit 2-7: Drugs Commonly Used for Rate Control in Atrial Fibrillation
Exhibit 2-8: Antiarrhythmic Drugs Under Development for the Treatment of AF
Exhibit 2-9: Recommendations for Antithrombotic Therapy for Atrial Fibrillation Based on Thromboembolic Risk Stratification
Exhibit 2-10: Selected Anticoagulation Alternatives Under Development for AF
Exhibit 2-11: Drug Therapy for Atrial Fibrillation, Patient and Treatment Forecasts, 2001-2010
Exhibit 2-12: Atrial Fibrillation Drugs, Market Forecast, 2001-2010
Exhibit 2-13: Anticoagulation Drugs for AF, Patients and Market Forecasts, 2001-2010
Exhibit 2-14: Antiarrhythmic Drugs for AF, Patient and Market Forecasts, 2001-2010
Exhibit 2-15: Rate Control Drugs for AF, Patient and Market Forecasts, 2001-2010
3.0 SURGICAL MANAGEMENT OF ATRIAL FIBRILLATION
3.1 Target Patient Population
3.2 Cox-Maze Procedure
3.2.1 Description
3.2.2 Indications
3.2.3 Outcomes
3.2.4 Complications
3.2.5 Costs
3.3 New Approaches
3.3.1 Less Invasive Maze Procedure
3.3.1.1 Endoscopic (Closed Chest) Approach
3.3.1.2 Beating Heart Approach
3.3.1.3 Limited Maze
3.3.2 Energy-Based Maze
3.3.3 Surgical Pulmonary Vein Isolation
3.4 Products and Suppliers
3.4.1 AFx
3.4.2 AtriCure
3.4.3 Boston Scientific
3.4.4 CardioFocus/Edwards Lifesciences
3.4.5 Endocare/CryoCath Technologies
3.4.6 Epicor
3.4.7 Galil Medical
3.4.8 Medtronic
3.4.9 Spectrasonics Imaging
3.5 Procedure Forecast
3.6 Market Analysis
Exhibit 3-1: The Cox-Maze Procedure
Exhibit 3-2: Criteria for Coverage of Surgical Maze Procedure
Exhibit 3-3: New Approaches to Surgical Maze Procedure, 2002
Exhibit 3-4: Comparison of Minimally Invasive Maze Approaches
Exhibit 3-5: Selected Surgical Ablation Technologies for Atrial Fibrillation, 2002
Exhibit 3-6: AFx Microwave Surgical Ablation System Flex Probes
Exhibit 3-7: AtriCure Bipolar System
Exhibit 3-8: Boston Scientific's Cobra System
Exhibit 3-9: CardioFocus' Optimaze Surgical Ablation System
Exhibit 3-10: CryoCath Technologies' SurgiFrost Cryoprobe
Exhibit 3-11: Medtronic Cardioblate Surgical Ablation Pen
Exhibit 3-12: Surgical AF Ablation, Procedure Forecast, 2001-2010
Exhibit 3-13: Surgical AF Ablation Systems, Market Forecast, 2001-2010
4.0 IMPLANTABLE DEVICES FOR THE MANAGEMENT OF AF
4.1 Rationale
4.2 Applications
4.2.1 Prevention of Atrial Fibrillation with Right Atrial Pacing
4.2.1.1 Multi-Site and Alternative-Site Atrial Pacing
4.2.1.2 Overdrive Atrial Pacing
4.2.1.3 Mode Switching
4.2.2 Rapid Atrial Pacing For the Termination of Atrial Arrhythmias
4.2.3 Ablate and Pace: Ventricular Pacing During AF
4.2.4 Low-Energy Atrial Defibrillation
4.3 Patient Population and Choice of Pacing Mode
4.4 Atrial Fibrillation Pacing Issues
4.4.1 Role of Single Chamber Atrial Pacing
4.4.2 Determining Optimal Pacing Site and Mode
4.4.3 Devices with Both Preventative and Termination Algorithms
4.5 Products and Suppliers
4.5.1 Biotronik
4.5.2 ELA Medical
4.5.3 Guidant
4.5.4 Medtronic
4.5.4.1 Medtronic CRM
4.5.4.2 Vitatron
4.5.5 St. Jude Medical
4.6 Market Analysis
4.6.1 AF Pacing Algorithms
4.6.2 Ablate and Pace
4.6.3 Implantable Cardioverter Defibrillators
Exhibit 4-1: Selected Clinical Trials Comparing Different Modes of Pacing in AF
Exhibit 4-2: Mode Switching Algorithms of Commonly Used Pacemakers
Exhibit 4-3: Atrial Antitachycardia Pacing Therapies
Exhibit 4-4: Ablate and Pace: Benefits and Limitations
Exhibit 4-5: Implantable Atrial Defibrillators: Benefits and Limitations
Exhibit 4-6: Selected Implantable Devices for the Management of Atrial Fibrillation
Exhibit 4-7: FDA Approved Pacemakers and Implantable Cardioverter Defibrillators for Atrial Fibrillation Therapy
Exhibit 4-8: Key Results of the ADOPT-A Clinical Trial
Exhibit 4-9: Pacemakers Incorporating AF Suppression Algorithms, Market Forecast, 2001-2010
Exhibit 4-10: Ablate and Pace, Procedure Forecast, 2001-2010
Exhibit 4-11: Ablate and Pace Pacemakers, Market Forecast, 2001-2010
Exhibit 4-12: Implantable Cardioverter Defibrillators with AF Capabilities, Market Forecast, 2001-2010
5.0 CATHETER-BASED MANAGEMENT OF ATRIAL FIBRILLATION
5.1 Catheter Ablation
5.1.1 Evolution of Atrial Fibrillation Mechanisms and Approaches
5.1.2. Approaches and Techniques
5.1.2.1 Catheter Maze
5.1.2.2 Focal Ablation
5.1.2.3 Pulmonary Vein Isolation
5.1.2.4 AV Node Ablation
5.1.2.4.1 AV Node Modification
5.1.2.4.2 Vagal Nerve Stimulation
5.1.3 Catheter Ablation Procedure
5.1.4 Trends in Catheter Ablation
5.1.4.1 Improved and Expanded Energy Sources
5.1.4.1.1 Radiofrequency
5.1.4.1.2 Microwave
5.1.4.1.3 Laser
5.1.4.1.4 Cryoablation
5.1.4.1.5 Ultrasound
5.1.4.1.6 Chemical Ablation
5.1.4.2 RF Product Refinements and Enhancements
5.1.5 Technologies and Products
5.1.5.1 Radiofrequency
5.1.5.1.1 Advanced Catheter Engineering
5.1.5.1.2 Bard Electrophysiology (C.R. Bard)
5.1.5.1.3 Biosense Webster (Johnson & Johnson)
5.1.5.1.4 Biotronik
5.1.5.1.5 Cardima
5.1.5.1.6 CathEffects
5.1.5.1.7 EP Technologies (Boston Scientific)
5.1.5.1.8 Irvine Biomedical
5.1.5.1.9 Medtronic
5.1.5.1.10 SEBRA
5.1.5.1.11 St. Jude Medical
5.1.5.1.12 TaCCor
5.1.5.1.13 Toray
5.1.5.1.14 VascoMed
5.1.5.2 Microwave
5.1.5.2.1 AFx
5.1.5.2.2 Arrow International
5.1.5.3 Cryoablation
5.1.5.3.1 CryoCath Technologies
5.1.5.3.2 CryoCor
5.1.5.4 Laser
5.1.5.4.1 CardioFocus
5.1.5.4.2 Lightwave Ablation Systems
5.1.5.5 Ultrasound
5.1.5.5.1 Atrionix (Johnson & Johnson Cordis)
5.1.5.5.2 Irvine Biomedical
5.1.5.5.3 Transurgical
5.1.6 Procedure Forecast
5.1.7 Market Analysis
5.2 Cardiac Electrophysiology Mapping
5.2.1 Mapping Goals
5.2.2 Techniques and Approaches
5.2.2.1 Conventional Mapping Studies
5.2.2.2 Advanced 3-D Mapping
5.2.2.3 Sensor-Based Electroanatomic Mapping
5.2.2.4 Navigation Technologies
5.2.3 Technologies and Suppliers
5.2.3.1 Acuson
5.2.3.2 Biosense Webster (Johnson & Johnson)
5.2.3.2.1 LASSO Circular Mapping Catheter
5.2.3.2.2 CARTO Electrophysiology Navigation System
5.2.3.3 CardioOptics
5.2.3.4 CathEffects
5.2.3.5 Endocardial Solutions
5.2.3.6 EP MedSystems
5.2.3.7 EP Technologies (Boston Scientific)
5.2.3.7.1 Constellation Basket Catheter
5.2.3.7.2 QMS Mapping System
5.2.3.7.3 Real Time Position Management System
5.2.3.7.4 Astronomer Plus with SLD
5.2.3.7.5 ICE Ultrasound Imaging Catheter System
5.2.3.8 Medtronic
5.2.3.9 Stereotaxis
5.2.3.10 St. Jude Medical
5.2.3.11 Super Dimension Ltd.
5.2.4 Procedure Forecasts
5.2.5 Market Analysis
5.3 Introducer Technologies and Accessories
5.3.1 Procedure and Technology
5.3.2 Complications and Contraindications
5.3.3 Products
5.3.4 Procedure Trends
5.3.5 Market Analysis
Exhibit 5-1: Approaches Used for Catheter-Based Ablation of Atrial Fibrillation
Exhibit 5-2: Current Challenges Associated with Catheter Maze Procedure
Exhibit 5-3: Advantages and Limitations of Focal Ablation
Exhibit 5-4: Advantages and Limitations of Pulmonary Vein Isolation
Exhibit 5-5: Advantages and Limitations of AV Node Ablation
Exhibit 5-6: Comparison of Major Energy Sources Utilized for AF Catheter Ablation
Exhibit 5-7: Selected Radiofrequency AF Catheter Ablation Systems, 2002
Exhibit 5-8: Bard Electrophysiology Stinger Ablation Catheters
Exhibit 5-9: Biosense Webster Navi-Star and Celsius Ablation Catheters
Exhibit 5-10: Cardima Revelation Ablation Microcatheter
Exhibit 5-11: CathEffects' Desai VectorCath RF Ablation Catheter
Exhibit 5-12: EP Technologies' Blazer, Polaris and Chilli-Cooled Ablation Catheters
Exhibit 5-13: Medtronic Ablation Catheters
Exhibit 5-14: SEBRA Electrophysiology System
Exhibit 5-15: Selected St. Jude AF Ablation Catheters
Exhibit 5-16: Selected AF Cryoablation Catheters Under Development, 2002
Exhibit 5-17: CryoCath Technologies' AF Ablation Catheters
Exhibit 5-18: CryoCor Cardiac Cryoablation System (CCCS)
Exhibit 5-19: CardioFocus Light Ring Balloon Catheter
Exhibit 5-20: Ultrasound AF Catheter Ablation Systems Under Development, 2002
Exhibit 5-21: Transurgical High Intensity Focused Ultrasound Ablation System
Exhibit 5-22: Obstacles to Rapid Adoption of AF Catheter Ablation
Exhibit 5-23: Atrial Fibrillation Catheter Ablations, Procedure Forecast, 2001-2010
Exhibit 5-24: Atrial Fibrillation Ablation Catheters, Market Forecast, 2001-2010
Exhibit 5-25: Major Cardiac Mapping Approaches
Exhibit 5-26: Selected Mapping and Navigation Technologies with Potential Application in AF, 2002
Exhibit 5-27: Biosense Webster CARTO System and LASSO Catheter
Exhibit 5-28: CardioOptics' Trans-Blood Vision System
Exhibit 5-29: Endocardial Solutions' EnSite 3000 System
Exhibit 5-30: EP Technologies' Constellation Catheter and QMS2 Mapping System
Exhibit 5-31: EP Technologies' Real Time Position Management System and Catheter
Exhibit 5-32: Medtronic LocaLisa Intracardiac Navigation System
Exhibit 5-33: Stereotaxis' MNS Technology
Exhibit 5-34: Advanced 3-D Intracardiac Mapping and Navigation, Procedure and Market Forecast, 2001-2006
Exhibit 5-35: Selected Introducer Technologies Applicable to Atrial Fibrillation, 2002
Exhibit 5-36: Selected Introducer Technologies, 2002
Exhibit 5-37: AF Transseptal Crossings, Procedure Trend and Market Analysis, 2001-2010
6.0 ADJUNCTIVE TRANSCATHETER TECHNOLOGIES
6.1 Stroke Prevention Products
6.1.1 PLAATO (Appriva Medical/ev3)
6.1.2 Embolic Diversion (MindGuard)
6.2 Internal Cardioversion
6.2.1 Technique
6.2.2 Indications
6.2.3 Products and Suppliers
6.2.3.1 EP MedSystems
6.2.3.2 Guidant
6.2.3.3 Rhythm Technologies
6.2.3.4 St. Jude Medical
6.2.3.5 VascoMed
6.3 Market Assessment
6.3.1 Catheter-Based Stroke Risk Management
6.3.2 Internal Cardioversion
Exhibit 6-1: Selected Catheter-Based AF Stroke Prevention Technologies Under Development, 2002
Exhibit 6-2: Appriva Medical's PLAATO Devices
Exhibit 6-3: MindGuard's Diverter
Exhibit 6-4: Selected AF Internal Cardioversion Technologies, 2002
Exhibit 6-5: EP MedSystems' ALERT System
Exhibit 6-6: Guidant's SYNCRUS System
Exhibit 6-7: Rhythm Technologies' Internal Cardioversion Products
Exhibit 6-8: Potential Market Scenario for AF Stroke Management Devices, 2005-2010
Exhibit 6-9: Potential Market Scenario for Internal Cardioversion Products for AF, 2001-2010
7.0 COMPANY PROFILES
7.1 AFx, Inc
7.2 Appriva Medical, Inc. (ev3, Inc.)
7.3 AtriCure, Inc.
7.4 Biotronik GmbH & Company
7.5 Boston Scientific Corporation (EP Technologies, Cardiac Pathways)
7.6 Cardima, Inc.
7.7 CardioFocus, Inc.
7.8 CardioOptics, Inc.
7.9 Cardiome Pharma Corporation
7.10 CathEffects LLC
7.11 CryoCath Technologies, Inc.
7.12 CryoCor, Inc.
7.13 Endocardial Solutions, Inc.
7.14 EP MedSystems, Inc.
7.15 Epicor, Inc.
7.16 Guidant Corporation
7.17 Irvine Biomedical Inc.
7.18 Johnson & Johnson
7.19 Medtronic, Inc.
7.20 Rhythm Technologies, Inc.
7.21 SNIA Group (ELA Medical, Sorin Biomedica)
7.22 Stereotaxis, Inc.
7.23 St. Jude Medical, Inc.
7.24 Transurgical, Inc.
APPENDIX: COMPANY LIST