U.S. Opportunities in Surgical Coronary Revascularization

497 Pages | 147 Exhibits | Forecasts Through 2008

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Companies Covered

A-Med Systems, Inc.

Baxter International, Inc.

CardioVention, Inc.

Chase Medical, Inc.

Coalescent Surgical, Inc.

Cohesion Technologies, Inc.

Computer Motion, Inc.

CryoLife, Inc.

Edwards Lifesciences Corporation

Estech, Inc.

Fusion Medical Technologies, Inc.

Guidant Corporation

Haemacure Corporation

Intuitive Surgical, Inc.

Johnson & Johnson

Jostra AG (Jostra Bentley Corporation)

Medtronic, Inc.

Pall Corporation

SNIA Group SpA/Sorin Biomedica Group

St. Jude Medical, Inc.

Terumo Corporation (Terumo Cardiovascular Systems)

Ventrica, Inc.

Vista Medical Technologies, Inc.

Table of Contents


Procedure Trends

Total Revascularization Products Market

Traditional Cardiopulomonary Bypass Products

Mini Bypass and Intracardiac Pumps

Anastomosis Devices

Beating Heart Surgery Disposables

Vein Harvesting Products

Other Emerging Technologies

Cardiac Surgical Sealants

Transmyocardial Revascularization

Product Suppliers


Summary Exhibit 1: Coronary Revascularization, Procedure Trend by Type, 2001-2008

Summary Exhibit 2: Open-Heart Surgeries by Approach, Procedure Forecast, 2001-2008

Summary Exhibit 3: Surgical Revascularization Products, Market Forecast, 2001-2008

Summary Exhibit 4: Traditional Cardiopulmonary Bypass Products, Market Forecast, 2001-2008

Summary Exhibit 5: Mini Bypass Products and Intracardiac Pumps, Market Forecast, 2001-2008

Summary Exhibit 6: Anastomosis Devices, Market Forecast, 2001-2008

Summary Exhibit 7: Beating Heart Surgery Core Disposables, Market Forecast by Type, 2001-2008

Summary Exhibit 8: Minimally Invasive Vein Harvesting, Market Forecast, 2001-2008

Summary Exhibit 9: Other Emerging Technologies, Market Forecast, 2001-2008

Summary Exhibit 10: Cardiac Surgical Sealants, Market Forecast, 2001-2008

Summary Exhibit 11: Transmyocardial Revascularization, Procedure and Market Forecast, 2001-2008

Summary Exhibit 12: Leading Suppliers of Surgical Revascularization Products, 2002



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 Radiographic Imaging Echocardiography Radionuclide Scanning Magnetic Resonance Imaging Coronary Angiography Intravascular Ultrasound Intracoronary Angioscopy

1.3.3 Emerging Diagnostic Modalities In Vitro Cardiac Markers Predictor Tests Monoclonal Antibody-Based Imaging of Thrombosis

1.4 Treatment of Cardiovascular Disease

1.4.1 Medical Management Traditional Medical Management Lipid-Lowering Drugs

1.4.2 Surgical Intervention Coronary Artery Bypass Surgery Valve Surgery and Treatment of Congenital Heart Defects Transmyocardial Revascularization Surgical Management of Atrial Fibrillation

1.4.3 Transcatheter Therapies Percutaneous Transluminal Coronary Angioplasty Coronary Stenting Laser Angioplasty Atherectomy Transcatheter Thrombectomy and Thrombolysis Transcatheter Defect and Valve Repair Percutaneous Transmyocardial Revascularization Catheter Ablation of Arrhythmias


Exhibit 1-1: The Heart

Exhibit 1-2: Selected Data on Deaths and Heart Diseases, 2000

Exhibit 1-3: Estimated Costs of Cardiovascular Disease and Stroke, 2003

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, 2003

Exhibit 1-10: Major Surgical Interventions for Cardiovascular Disease, 2003

Exhibit 1-11: Major Surgical Approaches Used to Perform Cardiothoracic Surgery

Exhibit 1-12: Transcatheter Interventions for Cardiovascular Disease, 2003



2.1 Cardiopulmonary Bypass

2.1.1 Extracorporeal Circuit

2.1.2 Complications

2.1.3 Products Blood Pumps Roller Pumps Centrifugal Pumps Oxygenators Design and Function Add On Features New Materials Products and Suppliers Accessories Blood Filters Hemoconcentrators Cannulae and Tubing Product Trends Cardio Medical Solutions CardioVention Chase Medical COBE/Sorin Embol-X Estech Guidant Jostra Bentley Medtronic Novare Surgical Systems Terumo New Materials and Coatings

2.2 Blood Recovery and Salvage

2.2.1 Cardiotomy Suction

2.2.2 Blood Salvage Autotransfusion Process Products and Technology

2.3 Myocardial Protection

2.3.1 Cardioplegia Circuit

2.3.2 Access for Cardioplegia

2.3.3 Cold versus Warm Cardioplegia

2.3.4 Products and Technology

2.4 Procedure Forecasts

2.4.1 Coronary Artery Bypass Graft Surgery

2.4.2 Valve Procedures

2.4.3 Other Procedures

2.5 Product Markets and Supplier Shares

2.5.1 Traditional Products Blood Pumps Traditional Bypass Disposables Supplier Shares

2.5.2 Emerging Bypass Disposables

2 5.2.1 Anastomosis Devices Anastomosis Assist Devices Embolic Protection Devices Mini Bypass Systems


Exhibit 2-1: Product Requirements for Open Heart Surgery Supported by Cardiopulmonary Bypass

Exhibit 2-2: Schematic of Cardiopulmonary Bypass Circuit

Exhibit 2-3: Potential Complications Associated with Cardiopulmonary Bypass

Exhibit 2-4: Components of Extracorporeal Circuit

Exhibit 2-5: Comparison of Roller and Centrifugal Pumps

Exhibit 2-6: Selected Heart-Lung Machines, 2003

Exhibit 2-7: Images of Selected Heart-Lung Machines, 2003

Exhibit 2-8: Selected Centrifugal Pump Systems, 2003

Exhibit 2-9: Images of Selected Centrifugal Pump Systems, 2003

Exhibit 2-10: Comparison of Soft-Shell and Hard-Shell Venous Reservoirs

Exhibit 2-11: Selected Membrane Oxygenators, 2003

Exhibit 2-12: Images of Selected Membrane Oxygenators, 2003

Exhibit 2-13: Selected Filters Employed in Cardiopulmonary Bypass Circuit

Exhibit 2-14: Selected Emerging Technologies for Reducing Bypass Complications

Exhibit 2-15: Cardio Medical Solutions Baladi Inverter

Exhibit 2-16: CardioVention CORx System

Exhibit 2-17: Chase Medical Tr3iumph Soft Occlusion Aortic Cannula

Exhibit 2-18: Embol-X Aortic Filter System

Exhibit 2-19: Estech Remote Access Perfusion Catheter

Exhibit 2-20: Guidant Heartstring Proximal Seal System

Exhibit 2-21: Jostra Bentley MECC System

Exhibit 2-22: Medtronic Portable Bypass System (PBS)

Exhibit 2-23: Novare Surgical Systems’ Enclose Anastomotic Assist Device

Exhibit 2-24: Features of Selected Autotransfusion Systems, 2003

Exhibit 2-25: Major Indications for Open Heart Surgery

Exhibit 2-26: Factors Impacting Revascularization Procedures Through 2010

Exhibit 2-27: Trend in CABG Surgery by Approach, Procedure Forecasts, 2001-2008

Exhibit 2-28: Stopped Heart versus Beating Heart CABG Surgery, Procedure Forecast, 2001-2008

Exhibit 2-29: Total Cardiopulmonary Bypass Caseload, Procedure Forecast, 2001-2008

Exhibit 2-30: Total Cardiopulmonary Bypass Products, Market Forecast, 2001-2008

Exhibit 2-31: Blood Pumps, Market Forecast by Type, 2001-2008

Exhibit 2-32: Traditional CPB Disposables, Market Forecast by Type, 2001-2008

Exhibit 2-33: Cardiopulmonary Bypass Products, Supplier Shares, 2002

Exhibit 2-34: Emerging Bypass Disposables, Market Forecast, 2001-2008

Exhibit 2-35: CPB Anastomosis Devices, Market Forecast by Type, 2001-2008

Exhibit 2-36: CPB Anastomosis Assist Devices, Market Forecast, 2001-2008

Exhibit 2-37: Embolic Protection Devices, Market Forecast, 2001-2008

Exhibit 2-38: CPB Mini Bypass Circuits, Market Forecast, 2001-2008



3.1 Beating Heart Techniques

3.2 Products

3.2.1 Stabilization and Positioning Products Abbey Surgical Chase Medical CoroNeo DMC Medical Limited Edwards Lifesciences ESTECH Geister Medizintechnik GmbH Genzyme Biosurgery Guidant Johnson & Johnson Ethicon (CardioVations, Heartport) Medcanica/POPCAB LLC MediVas OPCAB Medtronic

3.2.2 Anastomosis Devices Design Criteria Products Abbott Laboratories Aptus Medical Cardica Coalescent Surgical Converge Medical Cryolife Johnson & Johnson Cardiovations Jomed Kensey Nash Onux Medical St. Jude Medical Stanford University SuturTek U.S. Surgical Corporation Utrecht University Medical Center Vasconnect Vascular Innovations Ventrica

3.2.3 Anastomosis Assist Devices Guidant Novare Surgical Systems

3.2.4 Intrasurgical Cardiac Assist A-Med Systems HemoDynamic Systems Ltd. Impella Cardiotechnik Medtronic

3.2.5 Minimally Invasive Vein Harvesting Graft Sources Radial Artery Grafts Gastroepiploic Artery Grafts Internal Thoracic Artery Grafts Minimally Invasive Harvesting Techniques Harvesting Technique Advantages and Limitations Endoscopic versus Direction Vision Approaches Products

3.2.6 Intraluminal Shunts Design Application Advantages and Limitations Clinical Experience Products and Suppliers

3.3 Trend in Beating Heart Procedures

3.4 Markets Analysis

3.4.1 Cardiac Stabilizers, Positioners and Accessories

3.4.2 Anastomosis Devices

3.4.3 Anastomosis Assist Devices

3.4.4 Intracardiac Assist

3.4.5 Vein Harvesting Systems


Exhibit 3-1: Comparison of Beating Heart CABG Surgery Techniques, 2003

Exhibit 3-2: Selected Cardiac Stabilizers, Positioners and Retractor Systems, 2001

Exhibit 3-3: Abbey Surgical Angelini Articulated Retractor

Exhibit 3-4: Chase Medical TR3IPOD Stabilizer System

Exhibit 3-5: CoroNeo CorVasc Stabilizer and Retractor

Exhibit 3-6: DMC Medical Cardioview Positioner

Exhibit 3-7: Edwards Lifesciences PauZition Heart Positioner

Exhibit 3-8: ESTECH Universal Stabilizerwith STableSoft

Exhibit 3-9: Geister Medizintechnik Lectiang Stabilizer

Exhibit 3-10: Genzyme Immobilizer Cardiac Stabilizer

Exhibit 3-11: Guidant Beating Heart Products

Exhibit 3-12: CardioVations AXIS 360o and Flexsite Stabilization Systems

Exhibit 3-13: Medcanica POPCAB Stabilizer Patent Drawings

Exhibit 3-14: Medtronic Octopus 4 System

Exhibit 3-15: Medtronic Starfish NS Heart Positioner

Exhibit 3-16: Major Design Approaches for Automated Anatomosis Devices

Exhibit 3-17: Selected Automated Anastomosis Devices, 2003

Exhibit 3-18: Coalescent Surgical U-Clip Device

Exhibit 3-19: Deployment of Jomed SOLEM GraftConnector

Exhibit 3-20: Onux Medical Touche Suturing System

Exhibit 3-21: St. Jude Medical Symmetry Bypass System with Aortic Connector

Exhibit 3-22: Suturtek FastClose Device

Exhibit 3-23: U.S. Surgical VCS Clip

Exhibit 3-24: Ventrica Magnetic Vascular Positioner

Exhibit 3-25: Deployment of Ventrica MVP System

Exhibit 3-26: Selected Anastomosis Assist Devices, 2003

Exhibit 3-27: Guidant Heartstring Proximal Seal System

Exhibit 3-28: Novare Surgical Systems Enclose Anastomosis Assist Device

Exhibit 3-29: Selected Intracardiac Assist Devices, 2003

Exhibit 3-30: A-Med A-Syst and PARAFlow Right Heart Support Systems

Exhibit 3-31: Impella Cardiotechnik impella elect

Exhibit 3-32: Comparison of CABG Graft Sources

Exhibit 3-33: Advantages and Limitations of Minimally Invasive Vein Harvesting

Exhibit 3-34: Selected Minimally Invasive Vein Harvesting Systems, 2003

Exhibit 3-35: CardioVations' Clearglide Precision Bipolar Device

Exhibit 3-36: Genzyme Biosurgery SaphLITE System

Exhibit 3-37: Guidant VasoView System

Exhibit 3-38: U.S. Surgical GSI ENDOsaph Vein Harvest System

Exhibit 3-39: Advantages and Limitations of Intraluminal Shunting for Beating Heart CABG Surgery

Exhibit 3-40: Features of Selected Intracoronary and Intraluminal Shunts, 2003

Exhibit 3-41: Selected Intracoronary and Intraluminal Shunts, 2003

Exhibit 3-42: Minimally Invasive CABG Surgery, Procedure Forecast, 2001-2008

Exhibit 3-43: Minimally Invasive Cardiac Surgery Products, Market Forecast, 2001-2008

Exhibit 3-44: Stabilizers, Positioners and Accessories, Market Forecast, 2001-2008

Exhibit 3-45: Stabilizers, Positioners & Accessories, Supplier Shares, 2002

Exhibit 3-46: Beating Heart Anastomosis Devices, Market Forecast, 2001-2008

Exhibit 3-47: Beating Heart Anastomosis Assist Devices, Market Forecast, 2001-2008

Exhibit 3-48: Beating Heart Cardiac Assist Products, Market Forecast, 2001-2008

Exhibit 3-49: Minimally Invasive Vein Harvesting Systems, Market Forecast, 2001-2008

Exhibit 3-50: Minimally Invasive Vein Harvesting Systems, Supplier Shares, 2002



4.1 Endoscopic CABG

4.1.1 Products and Suppliers Computer Motion Procedure Requirements Clinical Experience Regulatory Status and Marketing Development Plans Johnson & Johnson/CardioVations/Heartport Products Procedure Clinical Experience Development Plans

4.1.2 Clinical Challenges and Benefits

4.1.3 Product Requirements

4.1.4 Market Analysis

4.2 Cardiac Robotics

4.2.1 Background

4.2.2 Technology Automated Mechanical Assist Devices Telemanipulators Autonomous Robots

4.2.3 Applications in Cardiac Surgery

4.2.4 Regulatory Issues

4.2.5 Reimbursement versus Benefits

4.2.6 Products Armstrong Healthcare Limited EndoAssist PathFinder endoVia Computer Motion AESOP ZEUS Robotic Surgical System Intuitive Surgical Micro Dexterity Systems Components NeuroDex and MicroDex University of California at Berkley Workstation Features Tactile Feedback Device Development Plans

4.2.7 Procedure Trend

4.2.8 Market Analysis

4.3 Advanced Visualization Systems

4.3.1 Technology

4.3.2 Requirements for Success

4.3.3 Products and Suppliers Estech Least Invasive Cardiac Surgery Intuitive Surgical Medisecur AG Microvision Inc. Medical Industry Alliances Clinical Resources Confocal 3-D Camera Olympus Optical Company Karl Storz Endoscopy VisionSense Vista Medical Technologies 3-D Endoscope Series 8000 System Other Visualization Systems Strategic Alliances VRex

4.3.4 Market Analysis


Exhibit 4-1: Computer Motion EndoStabilizer

Exhibit 4-2: Key Outcomes for Endo-ACAB Procedure

Exhibit 4-3: Port-Access International Registry Patient Characteristics

Exhibit 4-4: Mortality and Morbidity of Port-Access Cardiac Surgery

Exhibit 4-5: Endoscopic CABG Surgery, Procedure and Market Forecast, 2001-2008

Exhibit 4-6: Types of Surgical Robotics

Exhibit 4-7: Selected Robotic Systems with Potential Application to Cardiac Surgery, 2002

Exhibit 4-8: EndoAssist Mechanical Assist Device

Exhibit 4-9: Computer Motion ZEUS and AESOP Systems

Exhibit 4-10: Intuitive Surgical da Vinci System

Exhibit 4-11: Microdexterity RAMS Schematic and MicroDex Prototype

Exhibit 4-12: Robotic-Assisted Beating Heart Cardiac Surgery, Procedure Forecast, 2001-2008

Exhibit 4-13: Cardiac Robotic Systems, Market Forecast by Type, 2001-2008

Exhibit 4-14: Cardiac Robotic Systems, Supplier Shares, 2002

Exhibit 4-15: Methods of Achieving Three-Dimensional Endoscopic Visualization

Exhibit 4-16: Selected Current and Emerging Advanced Visualization Systems, 2003

Exhibit 4-17: Stand-Alone Advanced Visualization Systems, Market Forecast, 2001-2008



5.1 Surgical Sealant Design Criteria

5.2 Types of Surgical Sealants

5.3 Fibrin Sealants

5.3.1 Mechanism of Action

5.3.2 Development History

5.3.3 Commercial versus Non-Commercial Products

5.3.4 Autologous Platelet Gels Interpore Cross International Harvest Technologies PlasmaSeal ThermoGenesis Vivolution A/S

5.3.5 Allogenic Products

5.3.6 Viral Screening and Inactivation of Blood Products New Risks Viral Inactivation and Removal Methods

5.3.7 Commercial Fibrin Sealants/Surgical Hemostasis Products American Red Cross AuraZyme Pharmaceuticals Aventis Behring Baxter Hyland Immuno Cohesion Technologies/Angiotech Pharmaceuticals Fusion Medical Technologies/Baxter Haemacure Corporation

5.4 Recombinant Surgical Hemostasis Products

5.4.1 Cell Culture Technology (FibroGen/ZymoGenetics)

5.4.2 Transgenic Technology Pharming PPL Therapeutics

5.5 Alternatives to Hemostatic Sealants

5.5.1 Berlin Heart AG

5.5.2 C. R. Bard

5.5.3 Closure Medical Corporation

5.5.4 Cohesion Technologies/Angiotech Pharmaceuticals

5.5.5 CryoLife

5.5.6 Genzyme Biosurgery/Focal

5.5.7 Surgical Sealants Inc

5.5.8 Tissuemed

5.6 Market Analysis


Exhibit 5-1: Design Criteria for Ideal Surgical Sealant

Exhibit 5-2: Comparison of Major Categories of Surgical Sealants

Exhibit 5-3: Selected Biological Hemostatis Sealant Products, 2003

Exhibit 5-4: Current and Emerging Viral Inactivation and Removal Technologies

Exhibit 5-5: Advantages and Limitations of Non-Hemostatic Sealants

Exhibit 5-6: Selected Alternatives to Hemostasis Products, 2003

Exhibit 5-7: Cardiac Surgical Sealants, Market Forecast by Type, 2001-2008

Exhibit 5-8: Cardiac Surgical Sealants, Supplier Shares, 2002



6.1 Clinical Background

6.2 TMR Technique

6.3 Clinical Results

6.3.1 Long-Term Results

6.3.2 Adjunctive Use with CABG

6.3.3 Patient Selection

6.4 Proposed Mechanisms of Action

6.4.1 Channel-Mediated Perfusion

6.4.2 Angiogenesis

6.4.3 Myocardial Denervation

6.4.4 Placebo Effect

6.5 Products and Suppliers

6.5.1 AngioTrax

6.5.2 Cardiodyne

6.5.3 CardioGenesis

6.5.4 Montreal Heart Institute

6.5.5 Okayama University

6.5.6 PhotoMedex

6.5.7 PLC Medical Systems

6.5.8 Spectranetics/U.S. Surgical

6.6 Market Analysis

6.6.1 Procedure Forecast

6.6.2 Market Forecast

6.6.3 Competitive Analysis


Exhibit 6-1: Standard Angina Classification

Exhibit 6-2: Characteristics of "No Option" Angina Patients

Exhibit 6-3: Comparison of TMR and PMR

Exhibit 6-4: Transmyocardial Revascularization: Potential Mechanisms of Action

Exhibit 6-5: Selected Transmyocardial Laser Revascularization Programs

Exhibit 6-6: The CardioGenesis TMR 2000 Holmium:YAG Laser TMR System

Exhibit 6-7: PLC Medical Systems' Heart Laser 2 TMR System

Exhibit 6-8: Transmyocardial Revascularization, Procedure Forecast, 2001-2008

Exhibit 6-9: Transmyocardial Revascularization, Market Forecast, 2001-2008

Exhibit 6-10: Transmyocardial Revascularization, Market Shares, 2002



7.1 A-Med Systems, Inc.

7.2 Baxter International, Inc.

7.3 CardioVention, Inc.

7.4 Chase Medical, Inc.

7.5 Coalescent Surgical, Inc.

7.6 Cohesion Technologies, Inc.

7.7 Computer Motion, Inc.

7.8 CryoLife, Inc.

7.9 Edwards Lifesciences Corporation

7.10 Estech, Inc.

7.11 Fusion Medical Technologies, Inc.

7.12 Guidant Corporation

7.13 Haemacure Corporation

7.14 Intuitive Surgical, Inc.

7.15 Johnson & Johnson

7.16 Jostra AG (Jostra Bentley Corporation)

7.17 Medtronic, Inc.

7.18 Pall Corporation

7.19 SNIA Group SpA/Sorin Biomedica Group

7.20 St. Jude Medical, Inc.

7.21 Terumo Corporation (Terumo Cardiovascular Systems)

7.22 Ventrica, Inc.

7.23 Vista Medical Technologies, Inc.




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