U.S. Opportunities in the Management of Atrial Fibrillation

Published January 2002 | 417 Pages | 114 Exhibits | Forecasts Through 2010

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Companies Covered

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.

Table of Contents


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 



1.1 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 Lone Temporal Patterns Paroxysmal Persistent Permanent Other Types

1.3.3 Epidemiology and Prognosis Prevalence Incidence Prognosis

1.3.4 Pathological Triggers and Associated Conditions Acute Causes Tachycardia-Induced Tachycardia Post-operative AF AF Without Associated Heart Disease AF With Associated Heart Disease Neurogenic AF

1.3.5 Presentation and Sequelae Atrial Factors Pathology of Atrium in AF Mechanisms of AF Hemodynamic Consequences of AF Thromboembolism Pathophysiology of Thrombus Formation Clinical Implications

1.3.6 Patient Evaluation and Diagnosis Minimum Evaluation of the Patient with AF Additional Investigation of Selected Patients with Atrial Fibrillation Holter Monitoring and Exercise Testing Transesophageal Echocardiography Electrophysiology Study

1.3.7 Treatment Approaches Drug Therapy: Rhythm Control vs. Rate Control

1.3.8 Acute Management Restoration of Sinus Rhythm Pharmacological Cardioversion Electrical Cardioversion Prevention of Thromboembolism

1.3.9 Long-term Management Maintenance of Sinus Rhythm Pharmacological Therapy Surgical Ablation Catheter Ablation Internal Atrial Defibrillators Permanent Pacing Ventricular Rate Control Pharmacologic Therapy AV Nodal Ablation AV Node Modification Vagal Nerve Stimulation 

1.3.10 Thromboembolic Risk Management in AF Acute Prevention of Thromboembolism Reduction of Future Thromboembolic Risk in AF patients Interventional Reduction of AF Stroke Risk 

1.3.11 Hybrid Therapy Drugs and Electrical Cardioversion Improving Efficacy of Cardioversion Reduction of Atrial Remodeling Drugs and Catheter Ablation Limited Linear Atrial Ablation Ablation of AF Initiating Foci Drugs and Pacemakers Drugs and Pace-Termination Drugs and Pacing Prevention 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 



2.1 Classification Systems

2.2 Drug Therapy Algorithms 

2.3 Antiarrhythmic Drug Therapy 

2.3.1 Pharmacological Cardioversion Recommendations for Cardioversion Pharmaceutical Options With Proven Efficacy Amiodarone Dofetilide Flecainide Ibutilide Propafenone Qunidine Other Agents 

2.3.2 Pharmacological Maintenance of Sinus Rhythm

2.3.3 Pharmacological Rate Control Beta-Blockers Calcium Channel Blockers Digoxin Other Options Recommendations for Rate Control 

2.3.4 Rhythm Control versus Rate Control PIAF Study STAF Study AFFIRM Trial RACE Study 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



3.1 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 Endoscopic (Closed Chest) Approach Beating Heart Approach 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 



4.1 Rationale 

4.2 Applications 

4.2.1 Prevention of Atrial Fibrillation with Right Atrial Pacing Multi-Site and Alternative-Site Atrial Pacing Overdrive Atrial Pacing 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 Medtronic CRM 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



5.1 Catheter Ablation 

5.1.1 Evolution of Atrial Fibrillation Mechanisms and Approaches 

5.1.2. Approaches and Techniques Catheter Maze Focal Ablation Pulmonary Vein Isolation AV Node Ablation AV Node Modification Vagal Nerve Stimulation 

5.1.3 Catheter Ablation Procedure

5.1.4 Trends in Catheter Ablation Improved and Expanded Energy Sources Radiofrequency Microwave Laser Cryoablation Ultrasound Chemical Ablation RF Product Refinements and Enhancements

5.1.5 Technologies and Products Radiofrequency Advanced Catheter Engineering Bard Electrophysiology (C.R. Bard) Biosense Webster (Johnson & Johnson) Biotronik Cardima CathEffects EP Technologies (Boston Scientific) Irvine Biomedical Medtronic SEBRA St. Jude Medical TaCCor Toray VascoMed Microwave AFx Arrow International Cryoablation CryoCath Technologies CryoCor Laser CardioFocus Lightwave Ablation Systems Ultrasound Atrionix (Johnson & Johnson Cordis) Irvine Biomedical 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 Conventional Mapping Studies Advanced 3-D Mapping Sensor-Based Electroanatomic Mapping Navigation Technologies

5.2.3 Technologies and Suppliers Acuson Biosense Webster (Johnson & Johnson) LASSO Circular Mapping Catheter CARTO Electrophysiology Navigation System CardioOptics CathEffects Endocardial Solutions EP MedSystems EP Technologies (Boston Scientific) Constellation Basket Catheter QMS Mapping System Real Time Position Management System Astronomer Plus with SLD ICE Ultrasound Imaging Catheter System Medtronic Stereotaxis St. Jude Medical 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 



6.1 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 EP MedSystems Guidant Rhythm Technologies St. Jude Medical 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 



7.1 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.



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