U.S. Opportunities in Atrial Fibrillation Technologies

Companies Covered

Atrial Fibrillation Innovation Center

AtriCure, Inc

Atritech, Inc

Boston Scientific Corporation

Cardiac Pathways Corporation

Cardima, Inc

CardioFocus, Inc

CryoCath Technologies, Inc

CryoCor, Inc

Endocardial Solutions, Inc

Endoscopic Technologies, Inc

Epicor Medical, Inc

Guidant Corporation

Hansen Medical, Inc

Irvine Biomedical, Inc

Johnson & Johnson

MedicalCV, Inc

Medtronic, Inc

ProRhythm, Inc

St. Jude Medical, Inc.

Stereotaxis, Inc

Symphony Medical, Inc

Table of Contents

EXECUTIVE SUMMARY

Overview of Atrial Fibrillation

Patients and Treatments

Total Market

Catheter Ablation Technologies

Advanced Cardiac Mapping & Navigation

Surgical Ablation Technologies

Other Nonpharmacologic Therapies

Cardiac Rhythm Management Devices

Ablate and Pace Therapy

Postoperative AF Prophylaxis

Left Atrial Appendage Occlusion

Competitive Environment

 

Summary Exhibit 1: Atrial Fibrillation Patients by Age Group, 2005-2011

Summary Exhibit 2: AF Patients by Temporal Pattern, 2005-2011

Summary Exhibit 3: AF Patients Treated, All Modalities, 2005-2011

Summary Exhibit 4: Atrial Fibrillation Products, Market Forecast, 2005-2011

Summary Exhibit 5: AF Catheter Ablation: Patient, Procedure and Product Forecasts, 2005-2011

Summary Exhibit 6: Advanced Cardiac Mapping Systems and Catheters, Market Forecast, 2005-2011

Summary Exhibit 7: Surgical AF Ablation, Patient and Product Forecasts, 2005-2011

Summary Exhibit 8: Implantable Devices for Atrial Fibrillation, U.S. Market Forecast by Segment, 2005-2011

Summary Exhibit 9: Left Atrial Appendage Occlusion Devices, U.S. Market Forecast, 2007-2011

Summary Exhibit 10: Atrial Fibrillation Products, Supplier Shares, 2006

 

1.0 OVERVIEW OF ATRIAL FIBRILLATION

1.1 Cardiovascular System

1.1.1 Heart

1.1.2 Cardiac Cycle

1.1.3 Blood Vessels

1.1.4 Electrical Conduction System

1.2 Cardiac Rhythm Disorders

1.3 Atrial Fibrillation: Background

1.3.1 Description

1.3.2 Types and Classifications

1.3.2.1 Absence or Presence of Heart Disease

1.3.2.1.1 Lone AF

1.3.2.1.2 Concurrent AF

1.3.2.1.3 Secondary AF

1.3.2.2 Temporal Patterns

1.3.2.2.1 Paroxysmal AF

1.3.2.2.2 Persistent AF

1.3.2.2.3 Permanent AF

1.3.3 Risk Factors

1.3.3.1 Structural Heart Disease

1.3.3.2 Other Cardiac Arrhythmias

1.3.3.3 Endocrine and Metabolic Disorders

1.3.3.4 Surgery

1.3.3.5 Neurogenic Factors

1.3.3.6 Other Acute Events

1.3.3.7 AF Without Associated Heart Disease

1.3.4 Presentation and Sequelae

1.3.4.1 Atrial Factors

1.3.4.1.1 Pathology of Atrium in AF

1.3.4.1.2 Mechanisms of AF

1.3.4.1.3 Role of Autonomic Nervous System

1.3.4.2 Hemodynamic Consequences of AF

1.3.4.3 Thromboembolism

1.3.4.3.1 Pathophysiology of Thrombus Formation

1.3.4.3.2 Clinical Implications

1.3.4.3.3 Unmet Needs & Emerging Solutions

1.3.5 Prognosis

1.4 Atrial Fibrillation Diagnosis

1.4.1 Minimum Evaluation of the Patient with AF

1.4.2 Additional Investigations for AF

1.4.2.1 Holter Monitoring and Exercise Testing

1.4.2.2 Transesophageal Echocardiography (TEE)

1.4.2.3 Electrophysiology Study

1.5 Treatment of Atrial Fibrillation

1.5.1 Acute Management Strategies

1.5.1.1 Restoration of Sinus Rhythm

1.5.1.1.1 Spontaneous Cardioversion

1.5.1.1.2 Pharmacologic Cardioversion

1.5.1.1.3 Electrical Cardioversion

1.5.1.2 Ventricular Rate Control

1.5.2 Maintenance Strategies

1.5.2.1 Debate: Rhythm Control vs Rate Control

1.5.2.2 Maintenance of Sinus Rhythm

1.5.2.2.1 Pharmacologic Rhythm Control

1.5.2.2.2 Pacing-Based Rhythm Control

1.5.2.3 Ventricular Rate Control

1.5.2.3.1 Pharmacologic Rate Control

1.5.2.3.2 AV Node Ablation

1.5.2.3.3 AV Node Modification

1.5.2.3.4 Vagal Nerve Stimulation

1.5.3 Curative Strategies

1.5.3.1 Surgical Ablation

1.5.3.2 Catheter Ablation

1.5.3.2.1 Focal Ablation

1.5.3.2.2 Pulmonary Vein Isolation

1.5.3.2.3 Substrate Ablation

1.5.4 Thromboembolic Risk Management in AF

1.5.4.1 Acute Prevention of Thromboembolism

1.5.4.2 Reduction of Future Thromboembolic Risk

1.5.4.3 Device-Based AF Stroke Prophylaxis

1.5.5 Hybrid Therapy

1.5.5.1 Drugs and Electrical Cardioversion

1.5.5.1.1 Improved Efficacy of Cardioversion

1.5.5.1.2 Reduction of Atrial Remodeling

1.5.5.2 Drugs and Catheter Ablation

1.5.5.3 Drugs and Pacemakers

1.5.5.3.1 Drugs and Pace-Termination

1.5.5.3.2 Drugs and Pacing Prevention

1.5.5.3.3 Conclusion

 

Exhibit 1-1: The Heart

Exhibit 1-2: Overview of Selected Cardiac Arrhythmias

Exhibit 1-3: Classification of Atrial Fibrillation

Exhibit 1-4: Selected Risk Factors for Atrial Fibrillation

Exhibit 1-5: ATRIA Study: Baseline Characteristics of Atrial Fibrillation Patients

Exhibit 1-6: Diagnosis of Atrial Fibrillation

Exhibit 1-7: Treatment Strategies for Atrial Fibrillation

Exhibit 1-8: Cardioversion Strategies for Atrial Fibrillation

Exhibit 1-9: Maintenance Strategies for Atrial Fibrillation

Exhibit 1-10: Curative Strategies for Atrial Fibrillation

Exhibit 1-11: Stroke Rates in Relation to Age Among Patients with Atrial Fibrillation

Exhibit 1-12: Risk Factors for Ischemic Stroke and Systemic Embolism in Patients with Non-Valvular Atrial Fibrillation

Exhibit 1-13: Selected Studies of Catheter Ablation and Drug Therapy

 

2.0 PATIENTS AND PROTOCOLS

2.1 Atrial Fibrillation Statistics

2.1.1 Incidence

2.1.2 Prevalence

2.1.2.1 By Age

2.1.2.1.1 Epidemiological Studies

2.1.2.1.2 Conclusions

2.1.2.2 By AF Temporal Pattern

2.1.2.2.1 Epidemiological Studies

2.1.2.2.2 Conclusions

2.1.2.3 Silent AF

2.1.3 Postoperative Atrial Fibrillation

2.2 Current and Forecast AF Patient Populations

2.2.1 By Age Group

2.2.2 By Temporal Pattern

2.2.3 By Treatment

2.2.3.1 Reasons for Undertreatment

2.2.3.2 Treated Caseload

2.2.4 Postoperative Atrial Fibrillation

 

Exhibit 2-1: Selected Atrial Fibrillation Statistics

Exhibit 2-2: ATRIA Study: Prevalence of Atrial Fibrillation By Age

Exhibit 2-3: Overview of Selected Epidemiological Studies of Atrial Fibrillation

Exhibit 2-4: ATRIA Study: Projected Prevalence of AF in the U.S., 1995-2050

Exhibit 2-5: Outcomes of Selected Epidemiological Studies of AF Prevalence by Age

Exhibit 2-6: 2006 ACC/AHA/ESC Classification of Atrial Fibrillation

Exhibit 2-7: Selected Studies Focusing on Atrial Fibrillation Patients by Type, 2007

Exhibit 2-8: Selected Epidemiological Studies of Silent Atrial Fibrillation

Exhibit 2-9: Incidence of Postoperative Atrial Fibrillation

Exhibit 2-10: Atrial Fibrillation Patients by Age Group, 2005-2011

Exhibit 2-11: Atrial Fibrillation Patients by Temporal Pattern including First Episode, 2005-2011

Exhibit 2-12: Atrial Fibrillation Patients by Temporal Pattern, 2005-2011

Exhibit 2-13: Atrial Fibrillation Patients Treated, All Modalities, 2005-2011

Exhibit 2-14: Atrial Fibrillation Patients Undergoing Device-Based Treatments, 2005-2011

Exhibit 2-15: Postoperative Atrial Fibrillation, Patient Forecast, 2005-2011

 

3.0 CATHETER-BASED MANAGEMENT OF ATRIAL FIBRILLATION

3.1 Evolution of Atrial Fibrillation Mechanisms and Approaches

3.2 Catheter Ablation Procedure

3.3 Approaches and Techniques

3.3.1 Linear Ablation ("Catheter Maze")

3.3.2 Focal Ablation

3.3.3 Pulmonary Vein Isolation

3.3.3.1 Segmental Ostial Isolation

3.3.3.2 Circumferential Ostial Isolation

3.3.3.3 Pulmonary Vein Antrum Isolation

3.3.3.4 Clinical Experience

3.3.4 Substrate Ablation

3.3.5 Combined Approaches

3.4 Trends in Catheter Ablation

3.4.1 Energy Sources

3.4.1.1 Radiofrequency

3.4.1.2 Microwave

3.4.1.3 Laser

3.4.1.4 Cryoablation

3.4.1.5 High Intensity Focused Ultrasound

3.4.2 Product Refinements and Enhancements

3.5 Technologies and Products

3.5.1 Radiofrequency

3.5.1.1 Bard Electrophysiology (C.R. Bard)

3.5.1.2 Biosense Webster (Johnson & Johnson)

3.5.1.2.1 NaviStar Ablation Catheter

3.5.1.2.2 Celsius

3.5.1.2.3 EZ Steer Bi-Directional

3.5.1.2.4 Stockert 70 RF Generator

3.5.1.2.5 Clinical Experience

3.5.1.3 Boston Scientific Electrophysiology

3.5.1.3.1 Blazer Ablation Catheters

3.5.1.3.2 Chilli Cooled Ablation Catheters

3.5.1.3.3 EPT 1000 and Maestro Generators

3.5.1.4 Cardima

3.5.1.4.1 Revelation

3.5.1.4.2 Revelation Tx (RTx)

3.5.1.4.3 Revelation T-Flex

3.5.1.4.4 Revelation Helix & Helix STX

3.5.1.5 CardioOptics

3.5.1.6 CathRx

3.5.1.7 Endosense SA

3.5.1.8 Medtronic

3.5.1.9 St. Jude Medical

3.5.2 Microwave: Medwaves, Inc

3.5.3 Cryoablation

3.5.3.1 CryoCath Technologies

3.5.3.1.1 Freezor CryoAblation Catheter

3.5.3.1.2 Freezor Xtra and Freezor Max

3.5.3.1.3 Arctic Front

3.5.3.1.4 Arctic Circler 

3.5.3.1.5 CryoConsole

3.5.3.2 CryoCor

3.5.4 Laser: CardioFocus

3.5.5 High Intensity Focused Ultrasound: ProRhythm, Inc

3.6 Catheter Ablation Market Analysis

3.6.1 Patient Forecast

3.6.2 Procedure Forecast

3.6.3 Catheter Market Forecast & Supplier Shares

3.6.4 Capital Equipment Market Forecast & Supplier Share

 

Exhibit 3-1: Catheter-Based Approaches to AF Ablation

Exhibit 3-2: Schematic of Catheter Maze Procedure

Exhibit 3-3: Advantages and Limitations of Pulmonary Vein Isolation

Exhibit 3-4: Catheter-Based Pulmonary Vein Isolation (PVI)

Exhibit 3-5: Selected Studies of Pulmonary Vein Isolation for AF Ablation

Exhibit 3-6: Selected Studies of Substrate Ablation for AF

Exhibit 3-7: Selected Studies of Combined Approaches for Catheter Ablation

Exhibit 3-8: Comparison of Major Energy Sources Used for AF Catheter Ablation

Exhibit 3-9: Selected Studies of RF Ablation Catheter Refinements

Exhibit 3-10: Selected RadioFrequency AF Catheter Ablation Systems, 2007

Exhibit 3-11: Bard Electrophysiology Stinger Ablation Catheters

Exhibit 3-12: Biosense Webster Ablation Catheters

Exhibit 3-13: Boston Scientific Catheter Ablation Products

Exhibit 3-14: Cardima Revelation Ablation Microcatheters

Exhibit 3-15: CathRx's Modular Cardiac Catheters

Exhibit 3-16: Endosense TactiCath Catheter

Exhibit 3-17: Medtronic Ablation Catheters

Exhibit 3-18: Selected St. Jude Medical AF Ablation Catheters

Exhibit 3-19 Selected AF Cryoablation Catheter Systems, 2007

Exhibit 3-20: CryoCath Technologies' AF Ablation Technologies

Exhibit 3-21: Selected Studies of CryoCath's AF Cryoablation Products

Exhibit 3-22: CryoCor Cardiac Cryoablation System (CCCS)

Exhibit 3-23: Selected Studies of the CryoCor Cardiac Cryoablation System for AF

Exhibit 3-24: CardioFocus Laser Catheter Ablation System

Exhibit 3-25: Selected Studies of CardioFocus Laser Balloon AF Ablation Catheter

Exhibit 3-26: ProRhythm HIFU Ablation System

Exhibit 3-27: Selected Studies of the ProRhythm HIFU Ablation System for AF

Exhibit 3-28: AF Catheter Ablation, Patient & Procedure Forecast, 2005-2011

Exhibit 3-29: AF Ablation Catheters, Market Forecast, 2005-2011

Exhibit 3-30: AF Ablation Catheters, Supplier Shares, 2006

Exhibit 3-31: Ablation Capital Equipment, Market Forecast, 2005-2011

Exhibit 3-32: Ablation Capital Equipment, Supplier Shares, 2006

 

4.0 CARDIAC ELECTROPHYSIOLOGY MAPPING & NAVIGATION

4.1 Overview of Cardiac Mapping

4.2 Mapping Functions

4.3 Design Criteria

4.4 Techniques and Approaches

4.4.1 Conventional Mapping Studies

4.4.2 Advanced 3-D Mapping

4.4.3 Sensor-Based Electroanatomic Mapping

4.4.4 Navigation Technologies

4.4.5 Image Integration Software

4.4.6 Importance for Atrial Fbrillation

4.4.7 Potential Role in Surgical AF Ablation

4.5 Technologies and Suppliers

4.5.1 Biosense Webster (Johnson & Johnson)

4.5.1.1 LASSO Circular Mapping Catheter

4.5.1.2 CARTO XP System

4.5.1.3 CARTOMERGE

4.5.1.4 CARTO RMT

4.5.1.5 NOGA XP System and NOGASTAR Catheter

4.5.2 Boston Scientific Electrophysiology

4.5.2.1 Constellation Basket Catheter

4.5.2.2 Realtime Position Management System

4.5.2.3 Astronomer Plus with SLD

4.5.3 CardioOptics

4.5.4 Hansen Medical

4.5.5 Magnetecs

4.5.6 Stereotaxis

4.5.6.1 MNS Niobe II with CardioDrive and Navigant

4.5.6.2 Catheters and Accessories

4.5.6.3 Applications

4.5.6.4 Benefits

4.5.6.5 Strategic Alliances

4.5.7 St. Jude Medical/Endocardial Solutions

4.6 Procedure Forecast

4.7 Market Analysis

4.7.1 Systems and Suppliers

4.7.2 Advanced Mapping & Navigation Catheters and Suppliers

 

Exhibit 4-1: Functions of Cardiac Mapping in Atrial Fibrillation

Exhibit 4-2: Design Criteria for Cardiac Mapping and Navigation System

Exhibit 4-3: Major Cardiac Mapping and Navigation Approaches

Exhibit 4-4: Selected 3D Mapping & Navigation Technologies with Application in Atrial Fibrillation, 2007

Exhibit 4-5: Biosense Webster Advanced Cardiac Mapping Products

Exhibit 4-6: Boston Scientific EP Technologies’ Constellation Catheter

Exhibit 4-7: EP Technologies’ Real Time Position Management System and Catheter

Exhibit 4-8: CardioOptics’ SiteSeekir Trans-Blood Vision System

Exhibit 4-9: Hansen Medical Sensei Robotic Catheter System

Exhibit 4-10: Stereotaxis Niobe II System

Exhibit 4-11: St. Jude Medical EnSite System

Exhibit 4-12: Advanced 3D Mapping and Navigation, U.S. Procedure Forecast, 2005-2011

Exhibit 4-13: Advanced 3D Mapping & Navigation Systems, U.S. Market Forecast, 2005-2011

Exhibit 4-14: Advanced 3D Mapping & Navigation Systems, Supplier Shares, 2006

Exhibit 4-15: Advanced 3D Mapping & Navigation Catheters, U.S. Market Forecast, 2005-2011

Exhibit 4-16: Advanced 3D Mapping & Navigation Catheters, Supplier Shares, 2006

 

5.0 SURGICAL MANAGEMENT OF ATRIAL FIBRILLATION

5.1 Indications for AF Surgery

5.2 Goals of AF Surgery

5.3 Surgical Approaches to Atrial Fibrillation

5.3.1 Classical Cox-Maze Procedure

5.3.1.1 Description

5.3.1.2 Complications

5.3.2 Approaches Adapting Cox-Maze Principles

5.3.2.1 Surgical Pulmonary Vein Isolation

5.3.2.2 Modified Maze Procedures

5.3.2.2.1 Challenges

5.3.2.2.2 Complications

5.3.2.2.3 Clinical Outcomes

5.3.3 Left Atrial Appendage Exclusion

5.4 Directed Energy Sources

5.4.1 Radiofrequency Energy

5.4.2 Microwave Energy

5.4.3 Cryothermal Energy

5.4.4 Laser Energy

5.4.5 High-Intensity Focused Ultrasound

5.5 Minimally Invasive Approaches

5.5.1 Endoscopic and Video-Assisted Surgical Ablation

5.5.2 Intracardiac Beating Heart Pulmonary Vein Isolation

5.5.3 Robotically-Assisted Ablation

5.6 Regulatory Issues

5.7 Reimbursement

5.8 Products and Suppliers

5.8.1 Directed Energy Ablation Devices

5.8.1.1 AtriCure

5.8.1.1.1 Ablation Systems

5.8.1.1.2 Handpieces

5.8.1.1.3 Clinical Experience

5.8.1.1.4 High Intensity Focused Ultrasound

5.8.1.2 Boston Scientific/Guidant

5.8.1.2.1 Flex Probes

5.8.1.2.2 Clinical Experience

5.8.1.3 Cardima, Inc

5.8.1.4 CooperSurgical

5.8.1.5 CryoCath Technologies

5.8.1.5.1 SurgiFrost CryoSurgical Ablation System

5.8.1.5.2 FrostByte System

5.8.1.5.3 Freezor Catheters

5.8.1.6 Edwards Lifesciences

5.8.1.6.1 Optiwave 980 Cardiac Laser Ablation System

5.8.1.6.2 Clinical Experience

5.8.1.6.3 Product History

5.8.1.7 ESTECH

5.8.1.8 MedicalCV

5.8.1.9 Medtronic

5.8.1.9.1 Cardioblate 68000 Generator Surgical Ablation System

5.8.1.9.2 Cardioblate Handpieces

5.8.1.9.3 Navigator Tissue Dissector

5.8.1.9.4 Cardioblate Clinical Experience

5.8.1.10 Messerschmidt-Bolkow-Blohn

5.8.1.11 Spectrasonics Inc

5.8.1.12 St. Jude Medical

5.8.2 Adjunctive Technologies

5.8.2.1 Enhanced Medical Systems

5.8.2.2 Innovention Technologies LLC

5.8.2.3 Intuitive Surgical, Inc

5.9 Procedure Forecast

5.10 Market Analysis

5.11 Supplier Shares

 

Exhibit 5-1: Major Surgical Approaches to Treatment of Atrial Fibrillation

Exhibit 5-2: The Cox-Maze III Procedure

Exhibit 5-3: Selected Studies of the Cox-Maze Procedure for AF Ablation

Exhibit 5-4: Surgical Pulmonary Vein Isolation

Exhibit 5-5: Selected Studies of Surgical Pulmonary Vein Isolation

Exhibit 5-6: Outcomes of Modified Maze Procedures, Selected Studies

Exhibit 5-7: Comparison of Directed Energy Sources for Atrial Fibrillation Ablation

Exhibit 5-8: Endoscopic Access for MiniMaze Procedures

Exhibit 5-9: Surgical AF Ablation Suppliers and Technologies, 2007

Exhibit 5-10: AtriCure: Selected AF Ablation Handpieces

Exhibit 5-11: Selected Studies of AtriCure's Surgical AF Ablation Systems

Exhibit 5-12: Boston Scientific Guidant Flex Microwave Ablation Probes

Exhibit 5-13: Selected Studies of Guidant Microwave Surgical Ablation System

Exhibit 5-14: Selected Studies of Guidant Microwave Ablation System Using Minimally Invasive Approaches

Exhibit 5-15: Cardima Surgical Ablation Probe

Exhibit 5-16: Frigitronics CCS-200 Cardiovascular Cryosurgical System

Exhibit 5-17: Selected Studies of Frigitronics CCS-200 Cardiovascular Cryosurgical System

Exhibit 5-18: Selected CryoCath Technologies' Cardiac Cryoablation Products

Exhibit 5-19: Selected Studies of SurgiFrost Cryosurgical Ablation System

Exhibit 5-20: Optiwave 980 Cardiac Laser Ablation System

Exhibit 5-21: ESTECH Cobra Surgical Systems

Exhibit 5-22: Selected Clinical Studies of the Cobra System for AF Ablation

Exhibit 5-23: MedicalCV Atrilaze Surgical Ablation System

Exhibit 5-25: Selected Studies of Cardioblate Systems for Surgical AF Ablation

Exhibit 5-26: St. Jude Medical Epicor Cardiac Ablation System

Exhibit 5-27: Selected Suppliers of Adjunctive Technologies to Support Surgical AF Ablation, 2007

Exhibit 5-28: Enhanced Medical Systems' HeartLander System

Exhibit 5-29: Innoventions LLC's Prototype HARP System

Exhibit 5-30: Clinical Application of HARP Device

Exhibit 5-31: Intuitive Surgical daVinci System

Exhibit 5-32: Surgical AF Ablation, U.S. Procedure Forecast, 2005-2011

Exhibit 5-33: Surgical AF Ablation Systems, U.S. Market Forecast by Product Type, 2005-2011

Exhibit 5-34: Surgical AF Ablation Systems, U.S. Market Forecast by Major Segment, 2005-2011

Exhibit 5-35: Surgical AF Ablation Products, Supplier Shares, 2005-2006

 

6.0 OTHER NONPHARMACOLOGIC THERAPIES

6.1 Rhythm Control

6.1.1 Pacing Therapies

6.1.1.1 Atrial Pacing Strategies

6.1.1.1.1 Multisite Atrial Pacing

6.1.1.1.2 Alternative Site Atrial Pacing

6.1.1.1.3 Overdrive Atrial Pacing

6.1.1.1.4 Atrial Antitachycardia Pacing

6.1.1.2 Clinical Experience

6.1.1.3 Procedure and Market Forecast

6.1.1.4 Suppliers

6.1.2 Implantable Atrial Defibrillators

6.1.2.1 Design Approaches

6.1.2.2 Patient Selection

6.1.2.3 Benefits and Limitations

6.1.2.4 Clinical Experience

6.1.2.5 Products and Suppliers

6.1.2.5.1 Boston Scientific

6.1.2.5.2 Medtronic

6.1.2.5.3 Royal Victoria Hospital

6.1.2.6 Market Analysis

6.1.3 Internal Cardioversion

6.1.3.1 Technique

6.1.3.2 Indications

6.1.3.3 Products and Suppliers

6.1.3.3.1 EP MedSystems

6.1.3.3.2 Rhythm Technologies

6.1.3.3.3 St. Jude Medical

6.1.3.4 Market Assessment

6.2 Rate Control

6.2.1 AV Nodal Ablation

6.2.1.1 Benefits and Limitations

6.2.1.2 Clinical Outcomes

6.2.1.3 Current Recommendations

6.2.1.4 Procedure Forecast

6.2.1.5 Market Analysis

6.2.2 Nondestructive AV Node Modification

6.2.2.1 Slow Pathway Ablation

6.2.2.2 Neuromodulation (Vagal Nerve Stimulation)

6.2.2.2.1 Clinical Rationale

6.2.2.2.2 Approaches

6.2.2.2.3 Products and Suppliers

6.2.2.3 Cell Therapy

6.2.2.4 Gene Therapy

6.2.2.5 Market Assessment

6.3 Management of Postoperative AF

6.3.1 Device-Based Therapies

6.3.1.1 Pacing Therapies

6.3.1.2 Hemostatic Sealant

6.3.1.3 Electrical Cardioversion

6.3.2 Market Analysis

6.4 Stroke Prevention

6.4.1 Left Atrial Appendage Exclusion

6.4.1.1 Clinical Challenges

6.4.1.2 Products and Suppliers

6.4.1.2.1 AGA Medical

6.4.1.2.2 AtriCure

6.4.1.2.3 Atritech

6.4.1.2.4 Epitek

6.4.1.2.5 ev3 (PLAATO)

6.4.1.3 Market Analysis

6.4.1.3.1 Epicardial LAA Exclusion

6.4.1.3.2 Transcatheter LAA Occlusion

6.4.2 Embolic Diversion

 

Exhibit 6-1: Overview of Other Nonpharmacologic Therapies for AF Management

Exhibit 6-2: Overview of Atrial Pacing Strategies for AF

Exhibit 6-3: Atrial Antitachycardia Pacing Therapies

Exhibit 6-4: Selected Clinical Studies of Pacing for AF Prevention

Exhibit 6-5: AF Suppression Pacemakers, U.S. Procedure and Market Forecast, 2005-2011

Exhibit 6-6: FDA-Approved Pacemakers Offering AF Therapies

Exhibit 6-7: AF Suppression Pacemakers, U.S. Supplier Shares, 2005-2006

Exhibit 6-8: Implantable Atrial Defibrillators: Benefits and Limitations

Exhibit 6-9: Selected Clinical Studies of Implantable Atrial Defibrillators

Exhibit 6-10: Selected Implantable Atrial Defibrillation Products, 2006

Exhibit 6-11: Atrial Defibrillators, U.S. Procedure and Market Forecast, 2005-2011

Exhibit 6-12: Atrial Defibrillators, Supplier Shares, 2005

Exhibit 6-13: Selected AF Internal Cardioversion Technologies

Exhibit 6-14: Advantages and Limitations of AV Node Ablation

Exhibit 6-15: Selected Clinical Studies of AV Nodal Ablation

Exhibit 6-16: Ablate and Pace Therapy: U.S. Procedure Forecast, 2005-2011

Exhibit 6-17: Ablate and Pace Therapy: U.S. Market Forecast, 2005-2011

Exhibit 6-18: Overview of Nondestructive Methods for AV Node Modification

Exhibit 6-18: Selected Clinical Studies of AV Node Modification

Exhibit 6-19: Selected Studies of Vagal Nerve Stimulation for Rate Control of AF

Exhibit 6-20: Selected Studies of Gene Therapy for AV Node Modification

Exhibit 6-21: Overview of Device-Based Therapies for the Management of Postoperative Atrial Fibrillation

Exhibit 6-22: Symphony Medical's Fibrisyl-AF Kit

Exhibit 6-23: SYNCRUS Internal Cardioversion System

Exhibit 6-24: Selected Clinical Studies of the SYNCRUS System

Exhibit 6-25: Postoperative AF Prophylaxis, Patient and Market Forecast, 2005-2011

Exhibit 6-26: Device-Based Approaches for Stroke Prevention in AF

Exhibit 6-27: Selected Clinical Outcomes of Surgical LAA Exclusion

Exhibit 6-28: Left Atrial Appendage (LAA) Exclusion Products and Suppliers, 2006

Exhibit 6-29: AGA Medical's Amplatzer Septal Occluder

Exhibit 6-30: AtriCure's Atrial Exclusion Device

Exhibit 6-31: Atritech's WATCHMAN System

Exhibit 6-32: Selected Clinical Studies of Atritech's WATCHMAN System

Exhibit 6-33: Epitek's Anchorage Closure System

Exhibit 6-34: ev3's PLAATO System

Exhibit 6-35: Selected Clinical Studies of the PLAATO System

Exhibit 6-36: Epicardial LAA Occlusion, U.S. Procedure and Market Forecast, 2007-2011

Exhibit 6-37: Transcatheter LAA Occlusion, U.S. Procedure and Market Forecast, 2009-2011

Exhibit 6-38: MindGuard's Diverter

 

7.0 COMPANY PROFILES

7.1 Atrial Fibrillation Innovation Center

7.2 AtriCure, Inc

7.3 Atritech, Inc

7.4 Boston Scientific Corporation

7.4.1 Guidant Corporation

7.4.2 Cardiac Pathways Corporation

7.5 Cardima, Inc

7.6 CardioFocus, Inc

7.7 CryoCath Technologies, Inc

7.8 CryoCor, Inc

7.9 Endoscopic Technologies, Inc

7.10 Hansen Medical, Inc

7.11 Johnson & Johnson

7.12 MedicalCV, Inc

7.13 Medtronic, Inc

7.14 Stereotaxis, Inc

7.15 St. Jude Medical, Inc.

7.15.1 Endocardial Solutions, Inc

7.15.2 Epicor Medical, Inc

7.15.3 Irvine Biomedical, Inc

7.15.4 ProRhythm, Inc

7.16 Symphony Medical, Inc